UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
ASSOCIATION OF AMERICAN PHYSICIANS
& SURGEONS, INC., et al.,
Plaintiffs,
v.
FOOD & DRUG ADMINISTRATION, et al.,
Defendants,
and
DURAMED PHARMACEUTICALS, INC.,
Defendant-Intervenor.
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Civil Action No. 07-0668-JDB
MOTION TO ALTER AND AMEND JUDGMENT, FOR JUDGMENT ON
PARTIAL FINDINGS, FOR RECONSIDERATION OF DISMISSAL, AND
FOR LEAVE TO FILED AMENDED AND SUPPLEMENTAL
COMPLAINT
Pursuant to FED. R. CIV. P. 52(c), 59(e), and 60(b), plaintiffs Association of American
Physicians & Surgeons, Inc., Concerned Women for America, Family Research Council, and
Safe Drugs for Women (collectively, “Plaintiffs”) respectfully move this Court to reconsider and
to alter and amend the judgment of dismissal entered on March 4, 2008 and to enter judgment for
the Plaintiffs on Counts II, IV, and VI against defendants Food & Drug Administration (“FDA”),
its Commissioner, the United States, and defendant-intervener Duramed Pharmaceuticals, Inc.
(collectively, “Defendants”). In support thereof, as well as in the alternative, pursuant to FED. R.
CIV. P. 15(a), 15(b), and 15(d), Plaintiffs also seek this Court’s leave to file the enclosed
amended and supplemental complaint. Defendants indicated that they will oppose Plaintiffs’ mo-
tions.
A proposed order is attached. The opportunity for oral argument is requested.
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 1 of 49
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Dated: March 18, 2008 Respectfully submitted,
/s/ Lawrence J. Joseph
Lawrence J. Joseph, D.C. Bar No. 464777
1250 Connecticut Ave., NW, Suite 200
Washington, DC 20036
Telephone: (202) 669-5135
Telecopier: (202) 318-2254
Counsel for Plaintiffs
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 2 of 49
CERTIFICATE OF SERVICE
I hereby certify that on this 18th day of March 2008, I electronically filed the foregoing
“Motion to Alter and Amend Judgment, for Judgment on Partial Findings, for Reconsideration of
Dismissal, and for Leave to Filed Amended and Supplemental Complaint” (together with its ac-
company memorandum of law, exhibits, and proposed order) with the Clerk of the Court using
the CM/ECF system, which I understand to have caused service of Jane M. Lyons of the U.S.
Attorney’s Office for the District of Columbia, on behalf of the federal defendants, and of Ri-
chard M. Cooper, on behalf of defendant-intervenor Duramed Pharmaceuticals, Inc.
/s/ Lawrence J. Joseph
Lawrence J. Joseph
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 3 of 49
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
ASSOCIATION OF AMERICAN PHYSICIANS
& SURGEONS, INC., et al.,
Plaintiffs,
v.
FOOD & DRUG ADMINISTRATION, et al.,
Defendants,
and
DURAMED PHARMACEUTICALS, INC.,
Defendant-Intervenor.
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)
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)
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Civil Action No. 07-0668-JDB
MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS’
MOTION TO ALTER AND AMEND JUDGMENT, FOR JUDGMENT ON
PARTIAL FINDINGS, FOR RECONSIDERATION OF DISMISSAL, AND
FOR LEAVE TO FILED AMENDED AND SUPPLEMENTAL
COMPLAINT
Lawrence J. Joseph, D.C. Bar No. 464777
1250 Connecticut Ave., NW, Suite 200
Washington, DC 20036
Telephone: (202) 669-5135
Telecopier: (202) 318-2254
Counsel for Plaintiffs
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 4 of 49
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TABLE OF CONTENTS
Procedural Background ................................................................................................................4
Factual Background ......................................................................................................................4
Standards of Review .....................................................................................................................5
Rule 12(b)(1) ......................................................................................................................5
Rule 12(b)(6) ......................................................................................................................6
Rule 15(a) ...........................................................................................................................7
Rule 15(b) ...........................................................................................................................8
Rule 15(d) ...........................................................................................................................8
Rule 52(c) ...........................................................................................................................8
Rule 59(e) ...........................................................................................................................9
Rule 60(b) ...........................................................................................................................9
Argument ........................................................................................................................................9
I. This Court Has Jurisdiction ............................................................................................10
A. Subject-Matter Jurisdiction ................................................................................10
B. Sovereign Immunity ............................................................................................11
1. APA Waiver of Sovereign Immunity ...................................................11
a. Final Agency Action ...................................................................11
b. Adequate-Remedy Bar ................................................................12
c. Committed to Agency Discretion ..............................................13
2. Court’s Equity Jurisdiction ....................................................................14
3. Officers Not Sovereign ...........................................................................14
C. Standing ................................................................................................................16
1. Cognizable Injuries in Fact ....................................................................16
a. Unlawful Conduct .......................................................................17
b. Exposure to Competition ............................................................18
c. Informational Injury ....................................................................19
d. Patients’ Rights ............................................................................21
e. Collateral Estopppel ....................................................................22
f. Procedural Injury .........................................................................22
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 5 of 49
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2. Associational and Third-Party Standing ...............................................23
3. Zone of Interest ........................................................................................26
a. Ultra Vires Exception .................................................................26
b. Injuries Arguably within Zone ...................................................27
c. Suitable Challenger .....................................................................28
D. Jurisdiction for Injunctive or Declaratory Relief .............................................29
II. Complaint States Claim that Entitles Plaintiffs to Relief ...........................................29
A. Plaintiffs Exhausted FDA’s Petition Regulations ...........................................30
B. Exhaustion Not Required if Approval Remains Operative ............................32
C. Non-APA Exhaustion Not Required .................................................................33
III. Plan B’s Approval, Labeling and Distribution Violate FFDCA ...............................34
A. Counts II and VI: Unlawful Dual Rx-OTC Labeling .....................................35
1. §310.200 Cannot Switch Regulation for Order ...................................38
2. §310.200 Did Not Switch Regulation for Order .................................40
B. Count IV: Unlawful “Behind the Counter” Product .......................................43
C. Count VIII: Unlawful Exhaustion Regulations ...............................................44
IV. Court Should File AMended Complaint.......................................................................44
Conclusion ....................................................................................................................................45
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PROCEDURAL BACKGROUND
On April 12, 2007, plaintiffs Association of American Physicians & Surgeons, Inc.
(“AAPS”), Concerned Women for America (“CWA”), Family Research Council (“FRC”), and
Safe Drugs for Women (“SDW) (collectively, “Plaintiffs”) filed this action to challenge both the
substance and the procedure of the approval of a Supplemental New Drug Application
(“SNDA”) for levonorgestrel tablets, 0.75 mg (hereinafter “Plan B”) for age-bifurcated, dual
prescription (“Rx”) and over-the-counter (“OTC”) distribution by defendants Food & Drug Ad-
ministration, its Commissioner, and the United States (collectively, “FDA”). This Court granted
a motion to intervene by the manufacturer, Duramed Pharmaceuticals, Inc. (“Duramed”) pur-
suant to FED. R. CIV. P. 24(a)(2). On August 17, 2007, Plaintiffs filed their first amended com-
plaint (“FAC”), which Duramend and FDA (collectively “Defendants”) moved to dismiss pur-
suant to FED. R. CIV. P. 12(b)(1), also arguing under FED. R. CIV. P. 12(b)(6) that Counts II, IV,
V, and VI fail to state a claim. On March 4, 2008, the Court dismissed the action in its entirety
for lack of standing and for failure to state a claim. In conjunctions with motions to amend or
reconsider that judgment, Plaintiffs seek leave to file their second amended complaint (“SAC”)
to include new evidence, conform to the evidence and arguments provided in their opposition to
the motions to dismiss, and to add allegations post-dating the FAC.
FACTUAL BACKGROUND
When a district court reviews the actions of an administrative agency, it sits as an appel-
late court reviewing the administrative record on which the agency acted. Marshall County
Health Care Auth. v. Shalala, 988 F.2d 1221, 1226 (D.C. Cir. 1993). Where the record in ques-
tion is judicially noticeable, the “district court can consult the [administrative] record to answer
the legal question before the court” without converting a motion to dismiss into a motion for
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summary judgment. James Madison Ltd. v. Ludwig, 82 F.3d 1085, 1095 & n.6 (D.C. Cir. 1996).
Similarly, a court may rely on judicially noticeable information in deciding a motion under Rule
52(c). Parker v. Long Beach Mortg. Co., __ F.Supp.2d __, 2008 WL 53276, *7 (E.D.Pa.); ac-
cord Melton v. Cmty. for Creative Non-Violence, 1993 WL 367113, *4-*5 & *7 nn.3-4 (D.D.C.
1993); Stevens v. East Alabama Health Care Auth., 2005 WL 3288735, *1 & n.2 (M.D.Ala.
2005). Under the judicially noticeable facts or evidence, Plaintiffs raised the issues that underlie
Counts I through VI with FDA in response to an FDA Federal Register notice on Barr’s petition
(Pls.’ Mot. Ex. 1, at 27-53, 157-59), FDA considered the comments as part of its evaluation of
Barr’s SNDA (FDA Mot. Ex. 8, at 1), and FDA acted pursuant to 21 C.F.R. §310.200(b) (FDA
Mot. Ex. 9, at 2 n.3). Notwithstanding that FDA conceded that the comments addressed the dual
Rx-OTC issue, Tr. at 74-75, that Plaintiffs plead that they raised the Rx rulemaking issue, FAC
¶72, and that FDA filed a document that admits it considered the comments in approving the
SNDA, see FDA Mot. Ex. 8, at 1, the Court relied on Duramed’s reply brief for the proposition
that no record exists and that Plaintiffs did not present their challenges to FDA. Op. at 25 (quot-
ing Duramed Reply at 22). At oral argument, Plaintiffs’ counsel advised the Court that they
would seek judicial notice of their comments to demonstrate their presentation of their views to
FDA, but (as noted in two supplemental notices) the flu ran its course through counsel’s family,
Suppl. Joseph Decl. ¶¶4-6 (Pls.’ Mot. Ex. 2), and then Defendants withheld their response to
Plaintiffs inquiry pursuant to Local Rule 7(m) for several days, notwithstanding that their legal
theory is incompatible with the admission of Plaintiffs’ comments. See Pls.’ Mot. Ex. 3.
STANDARDS OF REVIEW
Rule 12(b)(1). To assess subject-matter jurisdiction, courts “must assume the challenging party’s
view of the merits.” Ciba-Geigy Corp. v. EPA, 801 F.2d 430, 439 (D.C. Cir. 1986) (ripeness);
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Sierra Club v. Gorsuch, 715 F.2d 653, 658 (D.C. Cir. 1983) (same for final agency action);
Catholic Social Service v. Shalala, 12 F.3d 1123, 1126 (D.C. Cir. 1994) (courts “must assume
the validity of a plaintiff’s substantive claim at the standing inquiry,” even if that “substantive
claim may be difficult to establish”). In ruling on Rule 12(b)(1) motions, courts take the plain-
tiff’s factual allegations as true and also “presume[] that general allegations embrace those spe-
cific facts that are necessary to support the claim.” Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871,
889 (1990); accord Nat’l Wildlife Fed’n v. Burford, 835 F.2d 305, 311-12 (D.C. Cir. 1987). Al-
though courts may explore matters outside the pleadings to determine their jurisdiction, Land v.
Dollar, 330 U.S. 731, 735 n.4 (1947); Herbert v. National Academy of Sciences, 974 F.2d 192,
197 (D.C. Cir. 1992), they first should provide notice to the parties and an opportunity to submit
affidavits and other materials. Gordon v. Nat’l Youth Work Alliance, 675 F.2d 356, 360 (D.C.
Cir. 1982); Herbert, 974 F.2d at 198 (“ruling on a Rule 12(b)(1) motion may be improper before
the plaintiff has had a chance to discover the facts necessary to establish jurisdiction”).
Rule 12(b)(6). Motions to dismiss under Rule 12(b)(6) allege that the pleadings fail to state a
claim upon which relief can be granted. FED. R. CIV. P. 12(b)(6). “FED. R. CIV. P. 8(a)(2) re-
quires only a short and plain statement of the claim showing that the pleader is entitled to relief,
in order to give the defendant fair notice of what the… claim is and the grounds upon which it
rests.” Bell Atl. Corp. v. Twombly, 127 S.Ct. 1955, 1964 (2007) (citations and interior quotations
omitted). “[A] complaint attacked by a Rule 12(b)(6) motion… does not need detailed factual
allegations,” id., provided that the plaintiff alleges “more than labels and conclusions, and a for-
mulaic recitation of the elements of a cause of action.” 127 S.Ct. at 1965. “Factual allegations
must be enough to raise a right to relief above the speculative level, on the assumption that all
the allegations in the complaint are true (even if doubtful in fact).” Id. (citations, interior quota-
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tions, and footnote omitted). With “other things… equal,” courts “prefer[] adjudication of cases
on their merits rather than on the basis of formalities.” Ciralsky v. CIA, 355 F.3d 661, 674 (D.C.
Cir. 2004). Under that judicial preference, such dismissals are appropriate where a “plaintiff has
no claim to state,” but inappropriate where the “plaintiff has imperfectly stated what may be an
arguable claim.” Alley v. R.T.C., 984 F.2d 1202, 1208 (D.C. Cir. 1993) (emphasis added).
“[O]nce a claim has been stated adequately, it may be supported by showing any set of facts con-
sistent with the allegations in the complaint.” Twombly, 127 S.Ct. at 1969.
The federal policy of deciding cases on the basis of substantive rights involved
rather than on technicalities requires that the plaintiff be given every opportu-
nity to cure a formal defect in the pleading. This is true even when the district
judge doubts that the plaintiff will be able to overcome the shortcomings in the
initial pleading. Thus, the cases make it clear that leave to amend the com-
plaint should be refused only if it appears to a certainty that the plaintiff cannot
state a claim.
5B CHARLES ALAN WRIGHT & ARTHUR R. MILLER, FEDERAL PRACTICE AND PROCEDURE, §1357
(3d ed. 2004 & Supp. 2007); Alley, 984 F.2d at 1208.
Rule 15(a). Under Rule 15(a), plaintiffs who already have filed an amended complaint may
amend their complaint only with the consent of the opposing parties or the court’s leave, which
courts “should freely give… when justice so requires.” FED. R. CIV. P. 15(a)(2). After dismissal
of an action, courts still must allow amendment “when justice so requires,” but only if the plain-
tiff meets the higher standard of Rule 59(e). Firestone v. Firestone, 76 F.3d 1205, 1208 (D.C.
Cir. 1996). Notwithstanding the discretion that courts have to decide whether to allow amend-
ment, a denial without sufficient reason (e.g., futility of amendment, undue delay, bad faith, dila-
tory motive, undue prejudice, or repeated failure to cure deficiencies by previous amendments)
constitutes an abuse of discretion. Caribbean Broad. Sys., Ltd. v. Cable & Wireless PLC, 148
F.3d 1080, 1083 (D.C.Cir.1998). Denial of leave to amend based on futility is warranted if the
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proposed claim would not survive a motion to dismiss. James Madison Ltd. v. Ludwig, 82 F.3d
1085, 1099 (D.C.Cir.1996). Moreover, courts can grant leave to amend while simultaneously
granting a motion to dismiss. Arent v. Shalala, 866 F.Supp. 6 (D.D.C. 1994)
Rule 15(b). Under Rule 15(b), a party “may move – at any time, even after judgment – to amend
the pleadings to conform them” to issues not raised by the pleadings but tried by the parties’ ex-
press or implied consent. FED. R. CIV. P. 15(b)(2).
Rule 15(d). Under Rule 15(d), a court “may, on just terms, permit a party to serve a supplemen-
tal pleading setting out any transaction, occurrence, or event that happened after the date of the
pleading to be supplemented,” even if “the original pleading is defective in stating a claim.” FED.
R. CIV. P. 15(d). Courts typically analyze Rule 15(d) motions under the same standard as those
under Rule 15(a). See U.S. v. Hicks, 283 F.3d 380, 385 (D.C. Cir. 2002).
Rule 52(c). In pertinent part, Rule 52(c) provides that “[i]f during a trial without a jury a party
has been fully heard on an issue and the court finds against the party on that issue, the court may
enter judgment as a matter of law against that party with respect to a claim… that cannot under
the controlling law be… defeated without a favorable finding on that issue.” FED. R. CIV. P.
52(c). Prior to 1991, such “judgments as a matter of law” applied only against plaintiffs under
former Rule 41(b), but the 1991 addition of Rule 52(c) (as clarified by its 1993 amendment)
plainly authorizes courts to enter such judgments against defendants:
This amendment makes clear that judgments as a matter of law in nonjury tri-
als may be entered against both plaintiffs and defendants and with respect to
issues or defenses that may not be wholly dispositive of a claim or defense.
FED. R. CIV. P. 52(c) Advisory Committee Note to 1993 Amendment; Morales Feliciano v. Rul-
lan, 378 F.3d 42, 59 (1st Cir. 2004) (“judgment under Rule 52(c) can be entered for or against
either a plaintiff or a defendant, regardless of the allocation of the burden of proof”); cf. St.
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Mary’s Honor Ctr. v. Hicks, 509 U.S. 502, 509-10 (1993) (where defendant “has failed to intro-
duce evidence which, taken as true, would permit the conclusion that [the defendant could pre-
vail]… the court must award judgment to the plaintiff as a matter of law under… Federal Rule of
Civil Procedure 52(c) (in the case of bench trials)”) (emphasis in original).
Rule 59(e). Rule 59(e) authorizes a “motion to alter or amend a judgment [within] 10 days after
entry of the judgment,” FED. R. CIV. P. 59(e), which “need not be granted unless the district court
finds that there is an intervening change of controlling law, the availability of new evidence, or
the need to correct a clear error or prevent manifest injustice.” Firestone, 76 F.3d at 1208 (cita-
tions and interior quotations omitted). With “other things… equal,” however, courts “prefer[]
adjudication of cases on their merits rather than on the basis of formalities.” Ciralsky v. C.I.A.,
355 F.3d 661, 674 (D.C. Cir. 2004). Courts sometimes respond to Rule 59(e) motions by finding
alternative bases for dismissal. Dage v. Johnson, __ F.Supp.2d __, 2008 WL 510332 (D.D.C.
2008) (Bates, J.).
Rule 60(b). Rule 60(b) authorizes a court to “relieve a party or its legal representative from a
final judgment, order, or proceeding” for several enumerated following reasons, FED. R. CIV. P.
60(b), including (1) ”mistake, inadvertence, surprise, or excusable neglect;” (2) ”newly discov-
ered evidence;” (3) ”fraud…, misrepresentation, or misconduct by an opposing party;” (4) ”the
judgment is void;” and (6) ”any other reason that justifies relief.” FED. R. CIV. P. 60(b)(1)-
(4), (6). The “mistake” in the first paragraph need not be mistake by the moving party. See FED.
R. CIV. P. 60 Advisory Committee Note to 1946 Amendment. The standards for granted relief
under Rule 60(b) are similar to those under Rule 59(e).
ARGUMENT
Where jurisdiction merges with the merits (i.e., “where the question of jurisdiction is de-
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pendent on decision of the merits”), courts may combine the merits and jurisdictional stages.
Land, 330 U.S. at 735; Herbert, 974 F.2d at 198 (if “disputed jurisdictional facts… are inextrica-
bly intertwined with the merits of the case [the court] should usually defer its jurisdictional deci-
sion until the merits are heard”). When (as here) plaintiffs allege that agency action authorizes
illegal conduct, a dismissal for lack of standing (even one expressly without prejudice) operates
as a dismissal with prejudice. Compare Nat’l Wrestling Coaches Ass’n v. Dep’t of Educ., 366
F.3d 930, 947 (D.C. Cir. 2004) (“Our holding today thus does not prevent appellants from ob-
taining review of their claims on the merits, when raised in a judicially reviewable case or con-
troversy”) (“NWCA”) with Coll. Sports Cncl. v. Dep’t of Educ., 465 F.3d 20, 23 (D.C. Cir. 2006)
(“The statutory and constitutional issues raised in this case have been conclusively settled by this
court in NWCA”). Accordingly, Plaintiffs respectfully request that the Court either reverse the
dismissal for pleading defects or address the merits of Plaintiffs’ claims where standing merges
with the merits (namely, Counts II, III, IV, VI).
I. THIS COURT HAS JURISDICTION
A. Subject-Matter Jurisdiction. Counts II, IV, and VI allege violations of FFDCA and
the Durham-Humphrey Amendments and therefore “arise under” federal law for 28 U.S.C.
§1331. See Herero People’s Reparations Corp. v. Deutsche Bank, A.G., 370 F.3d 1192, 1195
(D.C. Cir. 2004) (claim arises under federal law when the complaint alleges a violation of federal
law). Indeed, since 1976, §1331 has provided subject-matter jurisdiction to virtually all chal-
lenges to federal administrative agencies and officers. Califano v. Sanders, 430 U.S. 99, 105
(1977) (“cases seeking ‘nonstatutory’ review of Federal administrative action, absent the juris-
dictional amount in controversy… ‘arise under’ the Federal Constitution or Federal statutes, and
the committee believes they are appropriate matters for the exercise of Federal judicial power
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regardless of the monetary amount involved”) (quoting S. REP. NO. 94-996 at 12 (1976)). “The
obvious effect of [eliminating §1331’s amount-in-controversy requirement against federal agen-
cies and officers], subject only to preclusion-of-review statutes created or retained by Congress,
is to confer jurisdiction on federal courts to review agency action, regardless of whether the APA
of its own force may serve as a jurisdictional predicate.” Sanders, 430 U.S. at 107 (emphasis
added). Because no statute precludes review, §1331 plainly gives this Court jurisdiction over this
type of challenge.
B. Sovereign Immunity. Although no defendant raised it as a basis for dismissal, the doc-
trine of sovereign immunity would constitute an affirmative barrier to this Court’s granting relief
against FDA or the United States and so constitutes an affirmative part of plaintiffs’ showing to
support the requested relief against those defendants. As explained in Sections I.B.2 and I.B.3,
infra, Dr. von Eschenbach lacks sovereign immunity for ultra vires actions. As a private corpo-
ration, Duramed lacks sovereign immunity altogether.
1. APA Waiver of Sovereign Immunity. In APA’s 1976 amendments, Congress
“eliminat[ed] the sovereign immunity defense in all equitable actions for specific relief against a
Federal agency or officer acting in an official capacity.” Sea-Land Serv., Inc. v. Alaska R.R., 659
F.2d 243, 244 (D.C. Cir. 1982) (quoting S. Rep. No. 94-996, 8 (1976)) (emphasis added). Signif-
icantly, APA’s “waiver of sovereign immunity applies to any suit whether under the APA or
not.” Chamber of Commerce v. Reich, 74 F.3d 1322, 1328 (D.C. Cir. 1996) (emphasis added).
a. Final Agency Action. In pertinent part, the APA applies only to final agency
action. 5 U.S.C. §704. FDA is an APA agency, 5 U.S.C. §§551(1), 701(b), and the challenged
actions are “agency action,” which the APA defines to include “an agency rule, order,… or the
equivalent or denial thereof, or failure to act.” 5 U.S.C. §551(13). And “order” means:
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the whole or a part of a final disposition, whether affirmative, negative, in-
junctive, or declaratory in form, of an agency in a matter other than rule mak-
ing but including licensing[.]
Id. §551(6) (emphasis added). Congress used the term “agency action” to “bring[] together pre-
viously defined terms in order to simplify the language for judicial review provisions of Section
10 and to assure the complete coverage of every form of agency power, proceeding, action, or
inaction.” S. Doc. 248, at 197-98 (emphasis added); id. 255 (same). “In that respect, the term
[agency action] includes the supporting procedures, findings, conclusions, or statements of rea-
sons or basis for the action or inaction.” Id. (emphasis added). Thus, “agency action” has “com-
plete coverage” of every form of proceeding or action, including inaction.
The finality of FDA’s action also is unquestionable. Bennett v. Spear sets a two-part test
to determine whether agency action is final: (1) it “must mark the ‘consummation’ of the agen-
cy’s decision making process” and not “merely tentative or interlocutory” in nature; and (2) it
“must be one by which rights or obligations have been determined, or from which legal conse-
quences will flow.” 520 U.S. 154, 177-78 (1997) (internal citations and quotations omitted).
Here, FDA acted finally to approve Plan B’s unlawful dual Rx-OTC distribution, without the
rulemaking requirements required to remove a drug from the prescription requirements of
§503(b)(1). At the very least, FDA’s action has the legal consequence of insulating Duramed
from state-law challenges to its unlawful distribution of Plan B. See, e.g., S.D. CODIFIED LAWS
§36-11A-46(10) (state misbranding laws insulate manufacturers—but not others – from liability
for distributing drugs under FDA-approved label). Moreover, FDA purports to have authorized
Duramed to distribute Plan B under its dual Rx-OTC labeling, which certainly determines a right
with legal consequences.
b. Adequate-Remedy Bar. Duramed cites NWCA, 366 F.3d at 945, for the prop-
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osition that pharmacists cannot challenge FDA under the APA because they have an adequate
alternate remedy under 5 U.S.C. §704 to challenge others (e.g., their employers or state pharma-
cy boards). First, that judicial-review discussion is dicta because the plaintiffs lacked standing.
Ctr. for Law & Educ. v. Dep’t of Educ., 396 F.3d 1152, 1156 (D.C. Cir. 2005); Brief for the Res-
pondent in Opp’n, at 11, NWCA, No. 04-922 (U.S.), 2005 WL 997132 (“[b]ecause petitioners
lack standing…, [judicial review] is not properly presented here”). Second, the NWCA panel ma-
jority lacked the authority to overturn an en banc D.C. Circuit decision. Adams v. Bell, 711 F.2d
161, 167-68 & nn.35, 36 (D.C. Cir. 1983); accord 711 F.2d at 182 & n.58 (Wright, J., dissent-
ing).1 Third, it “borders on the incredible” to contend that an implied private right of action
against private parties displaces the “distinct form of proceeding” against an agency’s final ac-
tion. Int’l Ladies’ Garment Workers’ Union v. Donovan, 722 F.2d 795, 807 (D.C. Cir. 1983);
accord Int’l Union v. Brock, 477 U.S. 274, 285 (1986) (“although review of individual eligibility
determinations in certain benefit programs may be confined [to other venues], claims that a pro-
gram is being operated in contravention of a federal statute or the Constitution can nonetheless
be brought in federal court”) (collecting cases). Plaintiffs lack any adequate alternate remedy.
Transohio Savings Bank v. O.T.S., 967 F.2d 598, 906 (D.C. Cir. 1992) (alternate remedy inade-
quate if cannot provide rescission).
c. Committed to Agency Discretion. Under 5 U.S.C. §701(a)(2), courts will
find agency actions “committed to agency discretion by law” in “those rare instances where sta-
tutes are drawn in such broad terms that in a given case there is no law to apply.” Citizens to
1 The NWCA panel majority’s dicta relies on cases based on agency inaction, unlike
Adams v. Bell, which addressed final agency action under the governing statutes.
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Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971) (interior citations omitted, em-
phasis added); Heckler v. Chaney, 470 U.S. 821, 830 (1985) (“if no judicially manageable stan-
dards are available for judging how and when an agency should exercise its discretion,” then
§701(a)(2) precludes review). Of course, that an agency has discretion does not preclude judicial
review. 5 U.S.C. §706(2)(A) (judicial review of abuse of discretion). Defendants have not (and
cannot) identify any discretion committed to them to evade limits on their statutory authority.
2. Court’s Equity Jurisdiction. This Court long has had equity jurisdiction over fed-
eral officers that exceeds the jurisdiction of other district courts. Kendall v. Stokes, 37 U.S. (12
Pet.) 524, 580-81 (1838); Stark v. Wickard, 321 U.S. 288, 290 n.1 (1944); Peoples v. Dep’t of
Agric., 427 F.2d 561, 564 (D.C. Cir. 1970); Gamen v. Heckler, 746 F.2d 844, 851 (D.C. Cir.
1984). Essentially, the Court has common-law powers over such officers because its Maryland
predecessor had common-law powers over state officers, before Maryland ceded the district as a
federal enclave. Kendall, 37 U.S. at 580-81; Peoples, 427 F.2d at 565; Gamen, 746 F.2d at 851.
3. Officers Not Sovereign. For federal officers acting ultra vires, it is well settled
that sovereign immunity does not shield the officer from injunctive or declaratory relief because
the “officer is not doing the business which the sovereign has empowered him to do or he is
doing it in a way which the sovereign has forbidden.” Washington Legal Found. v. U.S. Sentenc-
ing Comm’n, 89 F.3d 897, 901 (D.C. Cir. 1996); Larson v. Domestic & Foreign Commerce
Corp., 337 U.S. 682, 689 (1949) (“where the officer’s powers are limited by statute, his actions
beyond those limitations are considered individual and not sovereign actions”). The D.C. Circuit
characterized as “breathtakingly broad” an Executive claim of non-reviewability in which courts
could review only those exercises of discretion that “violate a direct prohibition of another sta-
tute (or the Constitution),” Chamber of Commerce v. Reich, 74 F.3d 1322, 1329 (D.C. Cir.
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 17 of 49
15
1996), but even there “government concedes that a cause of action would lie… [against Execu-
tive action] that violated or caused others to violate an express prohibition of that Act or another
statute.” Id. (emphasis in original). What is clear then is that agency action in violation of the
organic statute or other relevant statutes is ultra vires the agency’s authority.
Relying on a Larson quotation in Pennhurst State School & Hosp. v. Halderman, 465
U.S. 89 (1984), however, the Court would exclude from the ultra vires doctrine both “substan-
tive and procedural errors” in the exercise of delegated power. Op. at 18. Because it involved an
agency delegated “broad discretion to provide ‘adequate’ mental health services” and plaintiffs
who argued “that [the agency] have not provided such services adequately.” Pennhurst, 465 U.S.
at 102, nothing in Pennhurst provided an opportunity to overturn the proposition that “where the
officer’s powers are limited by statute, his actions beyond those limitations are considered indi-
vidual and not sovereign actions.” Larson, 337 U.S. at 689, or Larson’s holding:
We hold that if the actions of an officer do not conflict with the terms of his va-
lid statutory authority, then they are the actions of the sovereign.
Larson, 337 U.S. at 695 (emphasis added). In sum, “substantive and procedural errors” that
“conflict with the terms of his valid statutory authority” are ultra vires Dr. von Eschenbach’s au-
thority, and he cannot claim sovereign immunity.2 Id.; Clark v. Library of Congress, 750 F.2d
89, 102 (D.C. Cir. 1984); Chamber of Commerce v. Reich, 74 F.3d 1322, 1328 (D.C. Cir. 1996);
Stafford v. Briggs, 444 U.S. 527, 539 (1980) (“[naming] the officer or employee, both in his offi-
cial capacity and acting under color of legal authority, [includes] also those cases where the ac-
2 Although the Court considers it undisputed that FDA has authority to approve an Rx-to-
OTC switch, Op. at 18 n.4, it is indisputable both that FDA did not apply that authority (which
requires a rulemaking) here and that the Plan B SNDA was not an Rx-to-OTC switch (i.e., the
final product is not OTC).
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16
tion is nominally brought against the officer in his individual capacity even though he was acting
within the apparent scope of his authority and not as a private citizen”) (quoting H.R. Rep. No.
1936, 86th Cong., 2d Sess., 3-4 (1960)); cf. Arent v. Shalala, 70 F.3d 610, 615 (D.C. Cir. 1995)
(Chevron analysis “is focused on discerning the boundaries of Congress’ delegation of authority
to the agency; and as long as the agency stays within that delegation, it is free to make policy
choices in interpreting the statute, and such interpretations are entitled to deference”).
C. Standing. Constitutional standing consists of a cognizable injury in fact caused by the
defendant and redressable by the court. Injury “need not be to economic or… comparably tangi-
ble” because an “identifiable trifle” suffices. Pub. Citizen v. FTC, 869 F.2d 1541, 1547-48 (D.C.
Cir. 1989). While direct injuries pose “little question” of causation or redressability, plaintiffs
have a heightened showing when government action affects third parties, who then cause injury.
Lujan v. Defenders of Wildlife, 504 U.S. 555, 561-62 (1992). Standing can be expanded by third-
party or associational standing and narrowed by prudential concerns such as the zone-of-interest
test. See Sections I.C.2-I.C.3, infra.
1. Cognizable Injuries in Fact. Duramed argued incorrectly that Plaintiffs need
standing for each count. Duramed Reply at 1. While “standing is not dispensed in gross,” Lewis
v. Casey, 518 U.S. 343, 358 n.6 (1996), standing doctrine has no nexus requirement outside tax-
payer standing. Duke Power Co. v. Carolina Envtl. Study Group, Inc., 438 U.S. 59, 78-81
(1978); DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 353 & n.5 (2006) (“once a litigant has
standing to request invalidation of a particular agency action, it may do so by identifying all
grounds on which the agency may have failed to comply with its statutory mandate”) (interior
quotations omitted). Thus, Plaintiffs must establish standing to challenge FDA’s approval under
any of their substantive bases for standing in order to challenge the unlawfulness of that approval
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 19 of 49
17
under all of their legal theories for vacatur of that approval:
[T]he fact of economic injury is what gives a person standing to seek judicial
review under the statute, but once review is properly invoked, that person may
argue the public interest in support of his claim that the agency has failed to
comply with its statutory mandate.
Sierra Club v. Morton, 405 U.S. 727, 737 (1972); In re Long-Distance Telephone Service Fed-
eral Excise Tax Refund Litigation, 501 F.Supp.2d 34, 45 (D.D.C. 2007) (“once standing is estab-
lished on a particular injury caused by the defendant and redressable in court, standing is estab-
lished for the entire applicable claim”).
a. Unlawful Conduct. The Court reasons that it is a “stretch” to suggest that
pharmacists face prosecution “when there has been no determination that Plan B is misbranded.”
Op. at 20. While both Congress and FDA’s regulations on dual Rx-OTC drugs in fact have “de-
termin[ed] that Plan B is misbranded,” Section III.A, infra (quoting S. Rep. No. 82-946, at 10
(1951) and 21 C.F.R. §310.200(d)), the Court’s primary error is even more fundamental: the
Plaintiffs argue that Plan B is misbranded. FAC ¶¶50, 102, 137(A)(iv)-(v). Because the subject-
matter analysis assumes Plaintiffs’ merits view, Catholic Social Service, 12 F.3d at 1126, Plain-
tiffs respectfully submit that the Court’s entire analysis of justiciability is fatally flawed.3
Nor is Plaintiffs’ merits view farfetched: the plain terms of §503(b)(1) render Plan B mi-
sbranded when held for OTC sale. 21 U.S.C. §353(b)(1). Moreover, as a regulated profession,
pharmacists need not risk prosecution for violating the ethical requirements of their profession
(or the ethical requirements of their religious faith) by dispensing a misbranded drug. Compare
3 The Court appears to have relied on the Rule 12(b)(6) standard that courts are not bound
by a complaint’s “legal conclusion couched as a factual allegation.” Op. at 6 (quoting Trudeau v.
FTC, 456 F.3d 178, 193 (D.C. Cir. 2006)).
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18
NRDC v. SEC, 606 F.2d 1031, 1042 (D.C. Cir. 1979) (investors who wish to behave in “ethically
sound manner” have standing to redress “arguabl[e] impair[ment]” from “lack of [allegedly re-
quired] information”) with Op. at 20. If a court (or agency) adopted a local rule that required vi-
olating the Rules of Professional Conduct, attorneys certainly could sue for declaratory or in-
junctive relief before exposing themselves to ethical charges.
b. Exposure to Competition. Although Plaintiffs framed physicians’ injury as
exposure to unlawful competition, FAC ¶¶19-20, the Court would require that a physician has
suffered a loss of revenue. Op. at 16. Before engaging in burdensome discovery with patients,
prospective patients, and neighboring pharmacies, Plaintiffs respectfully request that the Court
analyze the injuries that Plaintiffs plead under the standard of their merits view. See Section
I.C.1.a, supra (standing assumes Plaintiffs merits views).
How a plaintiff frames its injury can be outcome determinative in otherwise-identical sit-
uations. See CC Distributors, Inc. v. U.S., 883 F.2d 146, 151 (D.C. Cir. 1989) (“Gull Airborne is
inapplicable to this case for the simple reason that the disappointed bidder there framed its injury
in terms of the loss of a government contract, not the loss of an opportunity to compete for such
a contract” as CC Distributors did) (distinguishing Gull Airborne Instruments, Inc. v. Weinberg-
er, 694 F.2d 838 (D.C. Cir. 1982)). Here, Plaintiffs have framed their injury as exposure to com-
petition. FAC ¶¶19-20; Bristol-Myers Squibb Co. v. Shalala, 91 F.3d 1493, 1499 (D.C. Cir.
1996) (“injury claimed here is not lost sales, per se;… [r]ather the injury claimed is exposure to
competition”). Moreover, it is both indisputable and (at the pleading stage) admitted that physi-
cians face exposure to competition from OTC sales of Plan B.
Moreover, for the standing inquiry (and on the merits), it is indisputable that OTC Plan
B’s competition is unlawful because dual Rx-OTC Plan B is misbranded when held for OTC
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19
sale. 21 U.S.C. §353(b)(1); 21 C.F.R. §310.200(d). Moreover, even if Plan B were not mis-
branded when held for OTC sale, the fact that FDA’s action (approval of the SNDA) authorized
pharmacists to compete with physicians, when before they lawfully could not. See, e.g.,
M.C.L.A. §§333.16215, 333.17708(2)-(3), 333.17745(12) (limiting the dispensing of prescrip-
tion drugs in Michigan to various types of physicians and dentists and to staff under their super-
vision); M.C.L.A. §333.17764 (criminalizing sale of misbranded drug). As such, and contrary to
the Court’s reasoning about unfettered third-party choices, Op. at 16-17, injury is “fairly trace-
able to the administrative action contested…. if that action authorized the conduct or established
its legality.” Tel. & Data Systems, Inc. v. FCC, 19 F.3d 42, 47 (D.C. Cir. 1994) (emphasis add-
ed); Los Angeles v. Lyons, 461 U.S. 95, 105-06 (1983); Simon v. Eastern Kentucky Welfare
Rights Org., 426 U.S. 26, 45 n.25 (1976) (private injury traceable to government action if inju-
rious conduct “would have been illegal without that action”); Animal Legal Defense Fund v.
Glickman, 154 F.3d 426, 441-42 (D.C. Cir. 1998) (en banc); Air Reduction Co. v. Hickel, 420
F.2d 592, 594 (D.C. Cir. 1969).
c. Informational Injury. The Court’s analysis of informational standing rests on
series of errors. First, the endocrine-disruptor study at issue in American Farm Bureau was in-
ternal to EPA, whereas the drug labeling here is intended to benefit physicians, pharmacists, and
consumers. Compare Op. at 12-13 with 43 Fed. Reg. 4214, 4213 (1978) (“When a pharmacist,
physician, nurse, or other person dispenses the drug product to the patient, he or she is the dis-
penser within the meaning of the act and bears the responsibility for providing… the [patient]
labeling…. Patient labeling serves primarily as an informational adjunct to the physician-patient
encounter and is intended to reinforce and augment oral information given by the physician”)
(final rule on oral-contraceptive patient inserts), 44 Fed. Reg. 37,434, 37,435 (1979) (“prescrip-
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 22 of 49
20
tion drug labeling is intended to provide physicians with a clear and concise statement of the data
and information necessary for safe and effective use of the drug”) (final rule on “physician” Rx
labeling), and id. at 37,436 (“This statutory scheme for drug labeling is intended to provide phy-
sicians… with the information they need to prescribe a drug under conditions that maximize the
drug’s effectiveness and minimize its risks”); see also 21 C.F.R. §10.85(d)(1), (e) (FDA bound
by its rulemaking preambles); MacPherson v. Searle & Co., 775 F.Supp. 417, 420 (D.D.C. 1991)
(“The inserts must be written in lay terminology to FDA specifications and are intended specifi-
cally for the information of the actual users of the drug”).
Second, the Court’s reliance on Havens Realty incorrectly suggests that the information-
providing statute must contain its own cause of action for denial of the required information,
Compare Op. at 12-13 with Pub. Citizen v. U.S. Dep’t of Justice, 491 U.S. 440, 449-51 (1989)
(“Pub. Citizen v. DOJ”) (finding informational standing under Federal Advisory Committee Act,
which lacks any cause of action). Third, distinguishing the Public Citizen’s “Smokeless Tobac-
co” case, the Court focuses on the Smokeless Tobacco Act’s statutory requirements for labeling,
Op. at 13-14, without considering FFDCA’s similar statutory requirements. See 21 U.S.C.
§§352(a), (c), 353(b)(4), 355(d)(7). This statutory labeling requirement is particularly germane
for pharmacists, whose lot the Durham-Humphrey Amendments intended to improve. Op. at 22.
As explained in Section III.A, infra, Plan B’s unprecedented dual Rx-OTC labeling is both mi-
sbranded per se and falsely suggests that pharmacists lawfully may dispense that product OTC to
adults, notwithstanding the prohibition of §503(b)(1). Fourth and finally, the Court incorrectly
analyzes redressability under informational standing by assuming vacatur would leave Plaintiffs
without redresss. Compare Op. at 14-15 with FEC v. Akins, 524 U.S. 11, 25 (1998). As Akins
recognizes, vacatur of the agency action would put the parties back in the position they should
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21
have been in all along (here, a rulemaking in which Plaintiffs could seek label language and/or
FDA’s requiring Barr to submit sufficient data to satisfy the informational needs of physicians,
pharmacists, and patients). Akins held that such remands provide enough redress even if FDA (or
Barr) potentially could take actions on remand that would leave Plaintiffs no better off. Akins,
524 U.S. at 25 (remand redresses injury “even though the agency (like a new jury after a mistri-
al) might later, in the exercise of its lawful discretion, reach the same result for a different rea-
son”). Plaintiffs plainly have informational standing to seek the label changes (or data4) that
would redress their rights to information that FFDCA authorizes them to have.
d. Patients’ Rights. The parties, this Court, and the D.C. Circuit appear to agree
that the speculative nature of consumers’ injury from unsafe and ineffective emergency contra-
ceptives (like crash-proof tires) denies consumers standing to enforce their statutory right to safe
and effective products. Op. at 15-16. Under the circumstances, physicians can assert third-party
standing because they have suffered a constitutional injury in fact (Sections I.C.1.a-I.C.1.d, su-
pra), have a close relationship with patients, and “some hindrance” prevents the third party’s as-
serting its own rights. Am. Immigration Lawyers Ass’n v. Reno, 199 F.3d 1352, 1361-62 (D.C.
2000). Like lack of standing for speculative need for emergency contraceptive, “unawareness of
the injury” qualifies as a sufficient hindrance, id., at 1363, which applies here. See Ritter Decl.,
¶9 (“patients tend to trust in the safety inherent in government approval generally and FDA ap-
4 The 2007 Amendments to the Pediatric Research Equity Act (“PREA”) also provide
Plaintiffs a right to information, but were not included in Plaintiffs amended complaint in August
because Congress did not enact the statute until September. Under the circumstances, Rule 15(d)
authorizes amending the complaint to reflect materials that were not previously before the Court.
See SAC ¶58 (PREA amendments would apply and require disclosure of information if Court
vacates SNDA); 21 USC §355c(g)(2), (h)(1)-(2).
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22
proval specifically, these patients will neither appreciate nor even recognize the risks”). Similar-
ly, in Powers, the third party had “little incentive” to bring suit because “of the small financial
stake involved and the economic burdens of litigation.” 499 U.S. at 415. If patients learn about
Plan B (e.g., its overstated efficacy, unproven safety for repeat use, and lack of safety data for
young women), they simply will avoid it. As in Powers, they will have little incentive to sue.5 As
such, physicians can “by default [become] the right’s best available proponent.” American Immi-
gration Lawyers Ass’n, 199 F.3d at 1362 (quotations omitted).
e. Collateral Estopppel. The Court infers that Plaintiffs may have waived colla-
teral estoppel form AAPS v. FDA, No. 00-2898-HHK (Oct. 25, 2001). See Op. at 12 n.2. Plain-
tiffs concede only that that litigation was not mutual as to Duramed and so cannot bind Duramed
on any matters in which Duramed has a direct interest (e.g., vacatur of Duramed’s SNDA). See
Cutler v. Hayes, 818 F.2d 879, 887-90 (1987) (prior standing decision binding on private parties
who participated in FDA litigation). For declaratory relief against FDA not expressly involving
Duramed, however, Duramed’s rights are derivative of the sovereign’s rights, and the holding
against the sovereign binds Duramed. City of Tacoma v. Taxpayers of Tacoma, 357 U.S. 320,
340-341 (1958). On these issues, AAPS asserts mutual collateral estoppel against the sovereign
and its privies. U.S. v. Mendoza, 464 U.S. 154, 158 (1984) (citing Montana v. U.S., 440 U.S.
147, 153 (1979)).
f. Procedural Injury. If (and only if) Plaintiffs have substantive standing, they
5 The Court suggests that consumers’ interests “may not be truly at stake” because con-
sumers can reject Plan B if they learn of its shortcomings. Op. at 19. That presupposes that all
affected consumers in fact learn about Plan B’s shortcomings and ignores Plaintiffs’ ability to
assert the third-party rights of prospective patients. See Section I.C.2, infra.
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23
also can have standing to assert procedural injuries such as the denial of the rulemaking man-
dated by §503(b)(3) and §310.200(b). Fla. Audubon Soc. v. Bentsen, 94 F.3d 658, 665 (D.C. Cir.
1996) (en banc). Because Congress recognized that the Rx-OTC distinction affects consumers,
pharmacists, physicians, and drug manufacturers,6 the rulemaking that Congress mandated is
“designed to protect [the] threatened concrete interest of his that is the basis of [such plaintiffs’]
standing.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 573 n.8 (1992).
In addition to administrative procedural injuries, Plaintiffs also suffer the “civil proce-
dure” injury of FDA’s purporting to deny Plaintiffs the opportunity to bring this litigation. Given
that litigation is a form of First Amendment petition, Cal. Motor Transport Co. v. Trucking Un-
limited, 404 U.S. 508, 510 (1972) (“right of access to the courts is indeed but one aspect of the
right of petition”), Plaintiffs can assert this civil-procedural injury without the Florida Audubon
limits on purely procedural standing. Int’l Primate Protection League v. Adm’rs of Tulane Educ.
Fund, 500 U.S. 72, 77 (1991) (opportunity to file in “forum of… choice” is a cognizable injury
in fact); Elrod v. Burns, 427 U.S. 347, 373 (1976) (“loss of First Amendment freedoms, for even
minimal periods of time, unquestionably constitutes irreparable injury”).
2. Associational and Third-Party Standing. In a clever Latin turn of phrase that
confuses third-party standing with associational standing, Duramed’s counsel accuse Plaintiffs of
seeking not jus tertii standing, but “jus quarti” associational standing for seeking to assert the
rights of members’ members. Duramed Reply, at 2. Properly understood, jus tertii or third-party
6 See S. REP. NO. 82-946, at 2 (“the bill... will benefit drug manufacturers, retail druggists,
medical practitioners, and the public.”); H.R. REP. 700, at 9 (House “committee [was] deeply
conscious of the fact that the power to determine which drugs are prescription drugs and which
are over-the-counter drugs is one which affects drug manufacturers, drug wholesalers, retail
druggists, pharmacists, physicians, and, last but not least, the general public”).
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24
standing involves a litigant’s asserting the rights of a third party, FAIC Securities, Inc. v. U.S.,
768 F.2d 352, 357 (D.C. Cir. 1985); Schnapper v. Foley, 667 F.2d 102, 113 (D.C. Cir. 1981),
and associational or representational standing involve a litigant’s asserting the rights of its mem-
bers. Warth v. Seldin, 422 U.S. 490, 511 (1975) (under “representational standing,” “an associa-
tion may have standing solely as the representative of its members”); Hunt v. Washington State
Apple Advertising Comm’n, 432 U.S. 333, 343 (1977). That third-party standing and association-
al standing are different should be evident by their vastly different legal tests.7
Although no court in this jurisdiction has ever equated the two doctrines, a dissenting
judge once put them on the same continuum:
No such inquiry is necessary or has ever been required to support the limited
jus tertii standing of an organization in favor of its members. The issue of as-
sociational standing is far removed from the normal difficulties of jus tertii
standing because the association is the class of injured parties….
Ripon Soc., Inc. v. Nat’l Republican Party, 525 F.2d 567, 615 (D.C. Cir. 1975) (Bazelon, C.J.,
dissenting). Even there, Chief Judge Bazelon recognized the “far remove[]” between third-party
standing and associational standing. Id. Plaintiffs respectfully submit that Judge Urbina of this
Court properly characterized Duramed’s comparison as “misdirection”:
The defendants’ 12(b)(1) motion fails for misdirection. The defendants pre-
mise their Rule 12(b)(1) challenge on the belief that NABVETS claims jus ter-
tii standing. In actuality, however, NABVETS asserts its standing claim under
the theory of associational or organizational standing.
7 Third-party standing requires that the first-party plaintiff (a) has suffered a constitutional
injury in fact, (b) has a close relationship with the third party, and (c) some hindrance prevents
the third parties’ asserting their own rights. Am. Immigration Lawyers Ass’n v. Reno, 199 F.3d
1352, 1361-62 (D.C. 2000). Associational standing requires that “(a) [the association’s] mem-
bers would otherwise have standing to sue in their own right; (b) the interests it seeks to protect
are germane to the organization’s purpose; and (c) neither the claim asserted nor the relief re-
quested requires the participation of individual members in the lawsuit.” Hunt, 432 U.S. at 343.
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25
Lipsman v. Sec’y of Army, 257 F.Supp.2d 3, 6 (D.D.C. 2003) (citation and footnotes omitted).
Like Judge Urbina, this Court should disregard this misdirection.
With that background, it is clear both that an association of associations can assert assoc-
iational standing on behalf of the individual members of its member associations, N.Y. State Club
Ass’n, Inc. v. New York, 487 U.S. 1, 9 (1988), and that an association can assert third-party
standing based on the relationships between its members and third parties. Fraternal Order of
Police v. U.S., 152 F.3d 998, 1001-02 (D.C. Cir. 1998); Nat’l Cottonseed Prod. Ass’n v. Brock,
825 F.2d 482, 490 (D.C. Cir. 1987). Indeed, for third-party standing, the plaintiff (or plaintiff
organization) need not identify a specific third party: unspecified third parties such as potential
customers suffice. Nat’l Cottonseed Prod. Ass’n, 825 F.2d at 490 (citing FAIC Securities, 768
F.2d at 358); Craig v. Boren, 429 U.S. 190, 194-95 (1976); Carey v. Population Services, Int’l,
431 U.S. 678, 683 (1977) (allowing vendor with constitutional standing to assert privacy rights
of third-party “potential customers” for nonprescription contraceptives). Finally, once a plaintiff
or associational plaintiff has established constitutional standing, that plaintiff may rely on third-
party standing to satisfy the merely prudential zone-of-interest test. FAIC Securities, 768 F.2d at
357-61; Carey, 431 U.S. at 682-86.8 Indeed, the zone-of-interest test and third-party standing are
8 FDA invokes Mountain States Legal Found. v. Glickman, 92 F.3d 1228, 1232 (D.C. Cir.
1996), for the proposition that plaintiffs cannot rely on one interest to establish a constitutional
injury-in-fact and a different interest to meet the zone-of-interest test. FDA Mot. to Dismiss, at
16-17. That general holding has no bearing on the specific issue here: whether a plaintiff with
constitutional standing can rely on third-party standing to meet the zone-of-interest test. First,
Mountain States simply did not present the third-party issue. Second, if Mountain States had pre-
sented that issue, this Court would have an obligation to follow the earlier precedent of a intra-
Circuit split in authority. Indep. Cmty. Bankers of Am. v. Bd. of Governors of Fed. Reserve Sys.,
195 F.3d 28, 34 (D.C. Cir. 1999) (earlier-adopted panel decision controls because one three-
judge panel cannot overrule another).
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26
distinct inquiries, Am. Immigration Lawyers Ass’n, 199 F.3d at 1357, and “[s]atisfying the ‘zone
of interests’ test is usually easy when the plaintiff is able to establish third party standing.” Id.
3. Zone of Interest. The following sections argue that the zone-of-interest test is in-
apposite to ultra vires actions, that Plaintiffs are within the zones of interest, and that (if not)
Plaintiffs are suitable challengers. First, however, the zone-of-interest test is prudential – not
constitutional – and can be waived legislatively. Ctr. for Auto Safety v. NHTSA, 793 F.2d 1322,
1335-36 (D.C. Cir. 1986). In its legislative rulemakings, FDA waived constitutional and pruden-
tial standing, so prudential standing presents no barrier. 40 Fed. Reg. 40,689 (1975) (“It is the
opinion of the Commissioner that every citizen has standing in the courts to contest any action of
the agency, and that no objection relating to such standing will be interposed by the agency in
such cases”) (proposed rule); 42 Fed. Reg. 4688 (1977) (“commenters specifically commended
the Commissioner’s decision not to raise a lack of ‘standing’ as a basis for opposing review of
agency decisions”) (final rule). FDA’s taking that position in rulemaking preambles “obligates
the agency to follow it until it is amended or revoked.” 21 C.F.R. §10.85(d)(1), (e).
a. Ultra Vires Exception. Section I.B.3, supra, disputes the Court’s narrow read-
ing of ultra vires. Because the standing doctrine assumes Plaintiffs’ merits views, this Court
should assume that FDA lacks authority for a dual Rx-OTC product, which renders the zone-of-
interest test inapposite or implicates zone of interests of the overriding constitutional principles
presented by a lawless agency, making up the rules as it goes. Haitian Refugee Ctr. v. Gra-
cey, 809 F.2d 794, 812 (D.C. Cir. 1987); Catholic Social Serv. v. Shalala, 12 F.3d 1123, 1126
(D.C. Cir. 1994); Law Offices of Seymour M. Chase, PC v. FCC, 843 F.2d 517, 524 (D.C. Cir.
1988) (Williams, J., concurring) (“the zone-of-interests test is inapposite because the challenger
contends (in effect) that ultra vires acts of the agency have interfered with some common law or
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27
possibly constitutional interest”). By operating outside its delegation, FDA purports to make law
without the constitutional process for making law, violating “the separation-of-powers principle,
the aim of which is to protect… the whole people from improvident laws.” Metro. Washington
Airports Auth. v. Citizens for the Abatement of Aircraft Noise, 501 U.S. 252, 271 (1991) (internal
quotations omitted); cf. Ass’n of Data Processing Serv. Org’ns v. Camp, 397 U.S. 150, 153
(1970) (test asks whether plaintiff is “arguably within the zone of interests to be protected or re-
gulated by the statute or constitutional guarantee in question”).
b. Injuries Arguably within Zone. The “zone of interest” prong of standing is a
prudential doctrine that asks “whether the interest sought to be protected by the complainant is
arguably within the zone of interests to be protected… by the statute.” Nat’l Credit Union Ad-
min. v. First Nat’l Bank & Trust, Co., 522 U.S. 479, 492 (1998) (emphasis and alteration in orig-
inal) (“NCUA”). This Court found Plaintiffs’ asserted injuries outside the zone only for physi-
cians’ competitive and economic injuries. Op. at 17-18 & n.4. The test “struck the balance in a
manner favoring review, but excluding those would-be plaintiffs not even arguably within the
zone of interests to be protected or regulated by the statute.” Clarke v. Securities Industry Ass’n,
479 U.S. 388, 396-397 (1987).
The “zone of interest” test is a guide for deciding whether, in view of Con-
gress’ evident intent to make agency action presumptively reviewable, a par-
ticular plaintiff should be heard to complain of a particular agency decision. In
cases where the plaintiff is not itself the subject of the contested regulatory ac-
tion, the test denies a right of review if the plaintiff’s interests are so marginal-
ly related to or inconsistent with the purposes implicit in the statute that it can-
not reasonably be assumed that Congress intended to permit the suit. The test
is not meant to be especially demanding; in particular, there need be no indica-
tion of congressional purpose to benefit the would-be plaintiff.
Clarke, 479 U.S. at 399-400 (footnotes and citations omitted; emphasis added). Under the test,
“it suffic[es] to establish reviewability that the general policy implicit in the [relevant statutes]
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28
was ‘apparent’ and that ‘those whose interests are directly affected by a broad or narrow inter-
pretation of the Acts are easily identifiable.’” Clarke, 479 U.S. at 399 n.14.
Plaintiffs respectfully submit that – once this Court factors the unlawfulness of dual Rx-
OTC competition into its standing analysis – physicians’ competitive interests vis-à-vis phar-
macist are “arguably within the zone of interests” and plainly “affected by a broad or narrow in-
terpretation” of the Durham-Humphrey Amendments. See NCUA, 522 U.S. at 499 (“Although it
is clear that respondents’ objectives in this action are not eleemosynary in nature, under our prior
cases that, too, is beside the point”) (footnotes omitted).
c. Suitable Challenger. Even if not intended beneficiaries, plaintiffs satisfy the
zone of interests as “suitable challengers” if they have “interests… sufficiently congruent with
those of the intended beneficiaries that [they] are not more likely to frustrate than to further the
statutory objectives.” First Nat’l Bank & Trust Co. v. Nat’l Credit Union Admin., 988 F.2d 1272,
1275 (D.C. Cir. 1993). Although the Court finds physicians’ competitive injuries contrary to the
statutory purpose, Op. at 18 n.4, that finding can preclude suitable-challenger standing only for
the safety issue, not for the various bright-line statutory violations (e.g., §503(b)’s Rx-OTC di-
chotomy/rulemaking requirement and PREA’s data requirements) that Plaintiffs challenge:
Irrespective of whether the statutory scheme contemplates that competitive in-
terests will advance statutory goals, the court has held that the Hazardous
Waste Treatment Council line of cases is inapposite when a competitor sues to
enforce a statutory demarcation, such as an entry restriction, because the po-
tentially limitless incentives of competitors [are] channeled by the terms of the
statute into suits of a limited nature brought to enforce the statutory demarca-
tion.
Honeywell Int’l, Inc. v. EPA, 374 F.3d 1363, 1370 (D.C. Cir. 2004) (citing cases) (emphasis add-
ed, alteration in original), withdraw on part on other grounds, 393 F.3d 1315 (D.C Cir. 2005).
Physicians are suitable here because “entry-like restrictions” are less subject to manipulation
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29
than the open-ended safety standards. Id.
D. Jurisdiction for Injunctive or Declaratory Relief. Injunctive relief requires irrepara-
ble harm and inadequacy of legal remedies. Beacon Theatres, Inc. v. Westover, 359 U.S. 500,
506-07 (1959). The complaint meets that test. FAC ¶¶36-39. Moreover, those prerequisites do
not apply to requests for declaratory relief under the Declaratory Judgment Act, 28 U.S.C.
§§2201-2202. The fact that another remedy would be equally effective affords no ground for de-
clining declaratory relief, 28 U.S.C. §2201; Hurley v. Reed, 288 F.2d 844, 848 (D.C. Cir. 1961);
Tierney v. Schweiker, 718 F.2d 449, 457 (D.C. Cir. 1983), and showing “irreparable injury… is
not necessary for the issuance of a declaratory judgment.” Tierney, 718 F.2d at 457 (citing Steffel
v. Thompson, 415 U.S. 452, 471-72 (1974)); 10B WRIGHT & MILLER, FED. PRAC. & PROC.
Civ.3d §2766 (“[i]f the normal requirements of federal jurisdiction are present…, the court has
jurisdiction” for declaratory relief). Thus, even if not entitled to injunctive relief such as vacatur,
Plaintiffs are entitled to declaratory relief.
II. COMPLAINT STATES CLAIM THAT ENTITLES PLAINTIFFS TO RELIEF
In mistaken reliance on Defendants, the Court erroneously concludes that Plaintiffs failed
to exhaust FDA’s regulations. Op. at 23-28. It is unclear whether the Court considered that “ju-
risdictional,” Op. at 6, correctable under Rule 8(a), or a merits issue under Rule 12(b)(6). Jones
v. Bock, 127 S.Ct. 910, 926 (2007) (courts not free to require plaintiffs to plead exhaustion be-
cause “adopting different and more onerous pleading rules to deal with particular categories of
cases should be done through established rulemaking procedures, and not on a case-by-case basis
by the courts”); Simpkins v. D.C. Government, 108 F.3d 366, 371 (D.C. Cir. 1997) (exhaustion
jurisdictional, not merits, dismissal) with Federated Dept. Stores, Inc. v. Moitie, 452 U.S. 394,
399 n.3 (1981) (Rule 12(b)(6) dismissal is with prejudice). Although the amended complaint
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30
cures all of the foregoing issues under the Rule 60(b) standards, the Court made several errors
that implicate Rule 59(e).
At the outset, if Plaintiffs lack standing, any Rule 12(b)(6) judgment would be void under
Rule 60(b)(4) because “[a]ny statements by this Court on the question of the judicial review bar
would be unnecessary dicta.” Ctr. for Law & Educ., 396 F.3d at 1156. Indeed, such statements
here would be incorrect dicta because, if Plaintiffs establish their substantive standing, they also
would then have procedural standing to invalidate FDA’s regulatory exhaustion requirement in
Count VIII. See Section I.C.1.f, supra (procedural standing contingent on substantive standing);
Murphy Exploration & Production Co. v. Dept. of Interior, 270 F.3d 957, 958-59 (D.C. Cir.
2001) (plaintiff can challenge rule “apart from the original rulemaking… when [that] rule is
brought before this court for review of further [agency] action applying it”) (interior quotations
omitted). Even if Plaintiffs had failed altogether to participate in the Plan B process, their com-
plaint would state a claim on which relief could be granted (namely, invalidating both the SNDA
and FDA’s exhaustion regulations).
A. Plaintiffs Exhausted FDA’s Petition Regulations. In pertinent part, FDA defines an
“Interested person” as “a person who submits a petition or comment or objection… in an infor-
mal or formal administrative proceeding.” 21 C.F.R. §10.3(a) (emphasis added); cf. FAC ¶72
(plaintiffs submitted comments in ANPRM).9 Consistent with §503(b)(3), moreover, under
FDA’s regulations, a manufacturers’ SNDA to effect an Rx-to-OTC switch expressly constitutes
9 Garlic v. FDA, 783 F.Supp. 4, 5 (D.D.C. 1992), required exhaustion by plaintiffs who
neither petitioned nor participated in another party’s petition. Plaintiffs’ participation in Barr’s
petition renders Garlic inapposite. The Court’s suggestion (Op. at 25, emphasis in original) that
a party may seek review only of “its challenge” would create an anomaly: commenters opposing
a petition could not challenge FDA’s granting a petition without first re-petitioning for vacatur.
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31
a “petition” under §10.25(a). See 21 C.F.R. §§10.25(a)(1) (including forms under 21 C.F.R.
§314.50 among the FDA forms that constitute a petition under §10.25(a)), 310.200(b) (“Any in-
terested person may file a petition seeking such exemption, which petition may be pursuant to
Part 10 of this chapter, or in the form of a supplement to an approved new drug application”),
314.50 (“Applications and supplements to approved applications are required to be submitted in
the form… required under this section”) (emphases added). Thus, §310.200(b) unquestionably
makes Barr’s §314.50 application a petition under §10.25(a), and §10.3(a) unquestionably makes
Plaintiffs “interested persons” in that petition process.
“In reviewing a petition the Commissioner may use the following procedures… (3) A
Federal Register notice requesting information and views.” 21 C.F.R. §10.30(h)-(h)(3). FDA’s
ANPRM unquestionably was a “Federal Register notice requesting information and views”
about the issues raised by Barr’s SNDA, see 70 Fed. Reg. 52,050 (2005), and FDA unquestiona-
bly considered the ANPRM in deciding to grant Barr’s SNDA:
In our August 26, 2005, letter to you we stated that the Agency was unable to
reach a decision on the approvability of your application at that time because
of unresolved difficult and novel issues raised by your sNDA. On the same
day, the Agency issued an Advanced Notice of Proposed Rulemaking
(ANPRM) seeking input from the public on certain issues regarding Rx to
OTC switches, which related to the regulatory issues raised by your applica-
tion. The comment period on the ANPRM closed on November 1, 2005, and
the Agency received approximately 47,000 comments. FDA then hired a con-
tractor to summarize and categorize the comments, and we received the con-
tractor’s final reports on May 19, 2006. FDA has reviewed the comments and,
while they have provided the Agency with valuable insights regarding how the
Agency might enforce an age-based restriction like the one proposed by your
amended sNDA, we concur with the overwhelming majority of the comments
(from individuals both for and against the approval of your sNDA) that it is
not necessary to engage in rulemaking to resolve the novel regulatory issues
raised by your application.
We are now proceeding with further evaluation of your sNDA.
Letter from Andrew von Eschenbach, M.D., Acting Commissioner of Food and Drugs, to Joseph
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32
A. Carrado, M.Sc., R.Ph., Duramed Research, Inc., at 1 (July 31, 2006) (FDA Mot. Ex. 8, at 1)
(emphasis added); see also SAC ¶80 (Dr. von Eschenbach’s testified to Congress that FDA con-
sidered ANPRM issues).10
Because Plaintiffs did comment on the Federal Register notice that the Commissioner is-
sued in response to Barr’s petition, and FDA considered those comments in deciding to proceed
with Barr’s SNDA, Plaintiffs have satisfied both the letter and the spirit of FDA’s regulations.
As such, they expressly have complied with FDA’s petition regulation and expressly need not
seek further FDA consideration before filing suit. 21 C.F.R. §10.45(a), (e).
B. Exhaustion Not Required if Approval Remains Operative. Although Plaintiffs
raised the need for administrative exhaustion regimes to render an agency action inoperative dur-
ing a required intra-agency appeal, Pls.’ Opp’n at 30-31,11 the Court began and ended with “op-
tional” administrative remedies, without considering the inoperative issue. Op. at 24. Through
the revised complaint, Plaintiffs ask the Court to consider that FDA action must remain inopera-
tive – and do not, 21 C.F.R. §10.35(d) – pending intra-agency appeal to forestall APA review:
Agencies may avoid the finality of an initial decision, first, by adopting a rule
that an agency appeal be taken before judicial review is available, and, second,
by providing that the initial decision would be “inoperative” pending appeal.
Otherwise, the initial decision becomes final and the aggrieved party is en-
titled to judicial review.
10 However typically true the Court’s observation that “a SNDA is a relatively closed
process,” Op. at 23, it is neither true nor uncontested for any Rx-to-OTC SNDA or this SNDA.
11 When challenging “final agency action,” an APA plaintiff has no duty to exhaust optional
administrative remedies unless the disputed agency action remains inoperative during that fur-
ther administrative process. 5 U.S.C. §704 (“Except as otherwise expressly required by statute,
agency action otherwise final is final for the purposes of this section… unless the agency other-
wise requires by rule and provides that the action meanwhile is inoperative, for an appeal to su-
perior agency authority”).
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33
Darby v. Cisneros, 509 U.S. 137, 152 (1993) (emphasis added); EEOC v. Lutheran Social Serv.,
186 F.3d 959, 963-64 (D.C. Cir. 1999) (Darby held that “courts may not impose exhaustion re-
quirements in addition to those contemplated by an agency exercising its statutory authority un-
der [§704]”). “Courts are not free to impose an exhaustion requirement as a rule of judicial ad-
ministration where the agency action has already become “final” under [§704].” Darby, 509 U.S.
at 153-54; DSE, Inc. v. U.S., 169 F.3d 21, 27 (D.C. Cir. 1999) (courts not free to require intra-
agency appeals “[s]ince that decision is not rendered inoperative by a pending appeal”).
C. Non-APA Exhaustion Not Required. Even if Plaintiffs are wrong that §704 renders
FDA’s exhaustion regime unlawful or if this arises outside the APA where “exhaustion doctrine
continues to apply as a matter of judicial discretion,” Darby, 509 U.S. at 153-54, exhaustion still
provides no basis to defer judicial review.12 Citing FDA, the Court collapses the relevant exhaus-
tion exemptions to “futility,” Op. at 27, which does not accurately represent the controlling law:
“an administrative remedy may be inadequate where the administrative body is shown to be bi-
ased or has otherwise predetermined the issue before it.” McCarthy v. Madigan, 503 U.S. 140,
148 (1992) (citing cases). Moreover, courts “should not dismiss [a non-participating plaintiff’s
action] the agency in fact considered the statutory issue raised in the [complaint].” NRDC v.
EPA, 824 F.2d 1146, 1150-1152 (D.C. Cir. 1987) (en banc) (collecting cases); McKart v. U.S.,
395 U.S. 185, 197-99 (1969) (exhaustion not required where question “solely one of statutory
12 Although the Court finds analogy to §505(h)’s appellate review by manufactures to argue
for exhaustion, Op. at 26, the law cuts the opposite way: “We are satisfied that these affidavits
are material and that FDA’s rather abrupt procedures below provide reasonable grounds for
SKF’s failure to adduce them before the agency.” SmithKline Corp. v. FDA, 587 F.2d 1107,
1126 (D.C. Cir. 1978) (emphasis added); accord Independent Cosmetic Mfrs. & Distributors,
Inc. v. H.E.W., 574 F.2d 553, 556 n.4 (D.C. Cir. 1978).
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 36 of 49
34
interpretation” where “the proper interpretation [was] certainly not a matter of [agency] discre-
tion”).
As explained in Section II.A, supra, FDA has “predetermined the issue before it” in ap-
proving Barr’s SNDA. FDA analyzed the issues in the comments and predetermined that it none-
theless could approve Barr’s SNDA. But even if (in dereliction of its duties) FDA had not consi-
dered these issues in the SNDA proceeding, its Rule 12(b)(6) motion here denies FDA the op-
portunity to require exhaustion. As the Court described it in McCarthy, “in view of Attorney
General’s submission that the challenged rules of the prison were ‘validly and correctly applied
to petitioner,’ requiring administrative review through a process culminating with the Attorney
General ‘would be to demand a futile act.’” McCarthy, 503 U.S. at 148 (citing and quoting
Houghton v. Shafer, 392 U.S. 639, 640 (1968)). Dr. von Eschenbach has twice rejected Plaintiffs
arguments, first in the SNDA proceeding (including testimony to Congress), and now in exten-
sive briefing in this Court. FDA Br. at 34-45; FDA Reply at 18-25. This Court should not de-
mand the futile act of asking him a third time. Fox Television Stations, Inc. v. F.C.C., 280 F.3d
1027, 1040 (D.C. Cir. 2002) (“obviously would have been futile for the [plaintiffs] to have peti-
tioned the agency… to repeal” agency actions “where the Commission had just determined that
the [actions] in question were still necessary in the public interest”).
III. PLAN B’S APPROVAL, LABELING AND DISTRIBUTION VIOLATE FFDCA
The Parties already have agreed that the Court can reach the purely legal merits (i.e.,
Chevron part one) of Counts II and VI without the administrative record, and FDA’s flip-flop on
the source of behind-the-counter (“BTC”) approval authority convinces Plaintiffs that the De-
fendants are correct that the Court can reach the purely legal merits of Count IV without the
record. Compare FDA Br. at 40 (Barr did it) with FDA Reply at 22-23 (FDA did it). Even if
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 37 of 49
35
FDA had not reached these issues, “[n]othing in Chevron suggests that a court should hesitate to
decide a properly presented issue of statutory construction in hopes that the agency will someday
offer its own interpretation.” Consolidation Coal Co. v. Federal Mine Safety & Health Review
Comm’n, 824 F.2d 1071, 1080 n.8 (D.C. Cir. 1987); cf. Roosevelt v. E.I. DuPont de Nemours &
Co., 958 F.2d 416, 419 & n.5 (D.C. Cir. 1992) (appellate courts may decide pure questions of
law not decided below).
A. Counts II and VI: Unlawful Dual Rx-OTC Labeling. Count II alleges that Plan B vi-
olates the Durham-Humphrey Amendments’ Rx-OTC dichotomy by simultaneously bearing Rx
and OTC labeling in violation of §503(b)(4)(A)-(B). Assuming arguendo that Plan B remains an
Rx drug under §503(b)(4)(A) at all times, Count II further argues that Plan B violates the Dur-
ham-Humphrey Amendments by failing to have been removed from the Rx requirements of
§503(b)(1) “by regulation” under §503(b)(3) for its OTC sales. See FAC ¶¶102-103. Consistent
with the second argument, Count VI alleges that §503(b)(3) required a rulemaking to remove the
prescription requirements for OTC sales and that – to the extent that §310.200(b) purports to al-
low such removal by merely approving an SNDA – that §310.200(b) is ultra vires FDA’s author-
ity under §503(b)(3). FAC ¶¶124-125. FDA and Duramed argue that Plan B is at all times a pre-
scription drug under §503(b)(4)(A), which renders §503(b)(4)(B) inapposite. FDA Mot. at 38 &
n.27; Duramed Mot. at 30-31.13 Further, FDA and Duramed argue that §310.200(b) is a regula-
13 FDA and Duramed take the counter-intuitive position that Plan B’s OTC version falls
always under §503(b)(4)(A), never under §503(b)(4)(B), because FDA approved Plan B for dual
Rx-OTC dispensing. Although Plaintiffs dispute that this bridges §503(b)(4)’s Rx-OTC dichot-
omy, it nonetheless does not save Duramed: the admission that Rx-OTC Plan B falls always un-
der §503(b)(1) renders Plan B “misbranded while held for sale” under §503(b)(1)’s express
terms because FDA never promulgated the “regulation” that §503(b)(3) requires to remove Plan
B from §503(b)(1)’s prescription requirements.
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 38 of 49
36
tion that – consistent with §503(b)(3) – authorizes FDA to remove prescription requirements
merely by approving an SNDA. FDA Mot. at 42-43; Duramed Mot. at 44-45.14
The following two sections demonstrate that (1) FDA’s interpretation of §503(b)(3) and
§310.200(b) fails at Chevron Step One, and (2) FDA never intended §310.200(b) to eliminate the
requirement to proceed by regulation. FDA today simply has no idea what §310.200(b) meant, as
promulgated in 1954 through 1976. Thus, Duramed is wrong to suggest that “federal courts do
not have [the] extensive experience” needed here. See Duramed Mot. at 28. Quite the contrary,
this Court is expert at interpreting statutes and tracing regulatory promulgations back to their
sources, while agencies under improper political pressure (and powerful private interests) often
sidestep required procedures to force through their narrow interests, as quickly as possible.
Before addressing the procedures required by §503(b)(3) and §310.200(b), however,
Plaintiffs first address §503(b)(4)’s prohibition against dual Rx-OTC labeling.15 When enacting
the Durham-Humphrey Amendments’ statutory OTC-Rx dichotomy, Congress expressly deemed
the presence or absence of the Rx legend as mutually exclusive for Rx and OTC products, re-
spectively. The Senate Report expressed this intent:
Paragraph (4) of the new subsection requires that, in addition to the labeling
requirements of prescription drugs specified in paragraph (2) of the subsection,
14 Duramed claims that Plan B complies with 21 C.F.R. §201.100, Duramed Mot. at 29, but
ignores the requirement that drugs “be dispensed in accordance with section 503(b).” 21 C.F.R.
§201.100(a)(2). Without an FDA removal by regulation, Plan B is misbranded under §503(b)(1).
15 The various examples in the administrative record of FDA-approved drug products with
an Rx and OTC version are inapposite. See 70 Fed. Reg. at 52,051. Those examples involve the
same active ingredient (e.g., ibuprofen) appearing in different drug products (e.g., 400 mg. as Rx
and 200 mg. as OTC). See Duramed Mot. at 28 n.20. Plan B involves the same drug product (i.e.,
the identical pill and box) with simultaneous Rx and OTC distribution, which FDA had never
previously approved. FAC ¶53.
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37
the interstate label on such drugs must bear the statement “Caution: Federal
law prohibits dispensing without prescription.” On the other hand, over-the-
counter drugs are forbidden to bear a label containing this caution statement.
S. Rep. No. 82-946, at 10 (1951) (emphasis added). Although this history supports the clear di-
chotomy that §503(b)(4)(A) and §503(b)(4)(B) create, FDA and Duramed argue around it by
claiming that Plan B is not an OTC drug because it is at all times subject to prescription (i.e.,
subject only to §503(b)(4)(A)) and that Plan B’s dual Rx-OTC legend is not false. FDA Mot. at
38; Duramed Mot. at 33-34.16
Unfortunately, FDA’s contemporaneous and longstanding interpretation of the Durham-
Humphrey Amendments does not support their latter-day legerdemain:
Prescription legend not allowed on exempted drugs. The use of the prescrip-
tion caution statement quoted in [§]503(b)(4) of the act, in the labeling of a
drug exempted under the provisions of this section, constitutes misbranding.
Any other statement or suggestion in the labeling of a drug exempted under
this section, that such drug is limited to prescription use, may constitute mi-
sbranding.
21 C.F.R. §310.200(d) (emphasis in original). Like Plaintiffs’ interpretation of 21 C.F.R.
§310.200(b), this regulation goes back to 1954, 19 Fed. Reg. 7347, 7348 (1954), and clearly pro-
vides that drugs exempted under “this section” – i.e., §310.200(b) – cannot bear the Rx legend.
In other words, notwithstanding their unsupported statements to the contrary, FDA consistently
has interpreted the Durham-Humphrey Amendments to preclude dual Rx-OTC labeling.17 Thus,
16 On the other hand, Duramed admits that OTC Plan B is technically a separate new drug
from the former Rx-only Plan B. Duramed Mot. at 25 n.19; FDA Mot. at 39-40.
17 Although it amended the Rx legend’s text in 1997, Congress did not alter the Durham-
Humphrey Amendments’ Rx-OTC dichotomy. FAC ¶50; Fourco Glass Co. v. Transmirra, 353
U.S. 222, 227 (1957) (“it will not be inferred that Congress, in revising and consolidating the
laws, intended to change their effect unless such intention is clearly expressed”).
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38
contrary to the suggestion that there has been no determination of misbranding, Op. at 20, Con-
gress and FDA have conclusively found dual Rx-OTC labeling is per se misbranding.
The question whether a label statement falsely limits a drug product to prescription use
applies only to statements other than the Rx legend, 21 C.F.R. §310.200(d), and §502(a) defines
misbranding when a drug’s “labeling is false or misleading in any particular.” 21 U.S.C. §352(a).
For oral contraceptives, FDA itself has concluded that if consumers of oral contraceptive are not
“fully informed of the benefits and risks involved in [the] use” then the “oral contraceptive drug
product... is misbranded under [§]502.” 21 C.F.R. 310.501(a). Finally, because §503(b)(1) rend-
ers an Rx drug misbranded when held for OTC sale unless expressly removed from the Rx re-
quirement by a rulemaking under §503(b)(3), the Plan B labeling falsely implies that pharmacists
lawfully may hold Plan B for OTC sales.
1. §310.200 Cannot Switch Regulation for Order. Plaintiffs contend that the Dur-
ham-Humphrey Amendments plainly require FDA to act “by regulation” to remove prescription
requirements for a new drug. 21 U.S.C. §353(b)(3). FDA and Duramed claim that §310.200 con-
stitutes a “regulation” that allows FDA to remove prescription requirements by approving an
SNDA. FDA Mot. at 42-43; Duramed Mot. at 44-45.
In Ethyl Corp. v. EPA, 306 F.3d 1144, 1148 (D.C. Cir. 2002), this Circuit considered a
similar question under a statute that provided that the agency “shall by regulation establish me-
thods and procedures for making tests under this section.” EPA had adopted “CAP 2000” to
“provide[] criteria for individual automobile manufacturers to develop their own test methods
and procedures, which the EPA approves in a process that does not involve rulemaking.” Calling
CAP 2000 “the only ‘regulation’ in the picture,” the Court noted that it did not fulfill the statuto-
ry purpose (i.e., “establish methods and procedures for making tests”). Id. For that reason, the
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39
D.C. Circuit held that EPA had violated the statutory command to proceed by regulation. Ethyl
Corp., 306 F.3d at 1150; accord MST Express v. Dep’t of Transp., 108 F.3d 401, 403, 406 (D.C.
Cir. 1997). Like FDA and Duramed, EPA argued that “proceeding by regulation would be admi-
nistratively burdensome,” which court rejected because that “[o]bviously… cannot overcome a
clear congressional command.” Ethyl Corp., 306 F.3d at 1150.18 More recently, the D.C. Circuit
applied this similar reasoning to conclude that – even with the permissive “may” – an express
statutory procedure for reversing a prior agency action precludes agencies’ reversing such ac-
tions as a plain amendment. New Jersey v. EPA, __ F.3d __, 2008 WL 341338, *6 (D.C. Cir.)
Duramed goes to some length to establish that the Durham-Humphrey Amendments im-
proved the clarity of the Rx-OTC distinction, to the benefit of pharmacists and the public. Du-
ramed Mot. at 31-34. All of that history equally supports Plaintiffs’ views, provided that FDA
follow the statutorily mandated rulemaking procedure and that the resulting drug product does
not violate the statutory Rx-OTC dichotomy. Duramed also argues that Plaintiffs’ view would
violate §503(b)(1) and (b)(3), which require Rx distribution only when necessary and allow OTC
distribution when Rx distribution is unnecessary. Duramed Mot. at 23-24; see also id. at 26 (re-
jecting this purportedly absurd result). Consistent with the statute, however, Plaintiffs merely ask
that FDA proceed publicly by regulation, rather than secretly by order, and that the resulting new
drug product(s) (if approved) have labeling that complies with the statute (e.g., an Rx box and an
18 Duramed makes the hyper-technical argument that §503(b)(3)’s divergent use of singular
and plural for rulemaking and drugs somehow precludes Plaintiffs’ interpretation. Duramed Mot.
at 24. There is nothing inconsistent about a single rulemaking’s addressing multiple, similar
drugs. In any event, the Dictionary Act precludes Duramed’s argument. See 1 U.S.C. §1 (“In de-
termining the meaning of any Act of Congress… words importing the singular include and apply
to several persons, parties, or things [and] words importing the plural include the singular”). That
FDA must proceed by rulemaking does not limit FDA to a single rulemaking.
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40
OTC box). FDA’s own regulations demonstrate that such regulations have occurred often in the
past, 21 C.F.R. §310.201, and nothing precludes or allows FDA to proceed differently here.
2. §310.200 Did Not Switch Regulation for Order. Even if FDA could interpret
§310.200(b) to allow removing prescription requirements from new drugs, FDA did not interpret
§310.200(b) that way when FDA promulgated it in 1954. To the contrary, and contemporaneous-
ly with the Durham-Humphrey Amendments’ adoption, §310.200(b)’s predecessor required a
rulemaking to remove prescription requirements from a new drug. Until FDA amends that origi-
nal interpretation, both FDA and Duramed must live with (and within) it. 21 C.F.R.
§10.85(d)(1), (e); Lopez v. F.A.A., 318 F.3d 242, 246-47 (D.C. Cir. 2003) (courts will require
agencies to follow their regulations); U.S. v. Nixon, 418 U.S. 683, 695-96 (1974) (same).
In 1954, FDA promulgated §310.200(b)’s first predecessor (former 21 C.F.R. §1.108(c))
expressly pursuant to §503(b)(3). 19 Fed. Reg. 7347, 7347-48 (Nov. 13, 1954). In 1963, FDA
proposed and finalized §311.200(b)’s direct predecessor (former 21 C.F.R. §130.101(b)) ex-
pressly pursuant to §503(b)(1) and §503(b)(3). 28 Fed. Reg. 1449 (Feb. 14, 1963); 28 Fed. Reg.
6377 (June 20, 1963). In pertinent part, and consistent with the plain statutory text (see Section
III.A.1, supra), the 1954 and 1963 versions both expressly required a rulemaking to remove a
new drug from prescription requirements under §503(b)(1), even if the “petition” that triggered
the rulemaking came to FDA via an SNDA or on FDA’s own initiative. See 19 Fed. Reg. at
7347-48 (promulgated 21 C.F.R. §1.108(c)); 28 Fed. Reg. at 6385 (promulgated 21 C.F.R.
§130.101). Specifically, in both 1954 and 1963, the final regulation provided as follows:
A proposal to exempt a drug from the prescription-dispensing requirements of
section 503(b) (1) (C) [now §503(b)(1)(B)] of the act may be initiated by the
Commissioner or by any interested person. Any interested person may file a
petition seeking such exemption, stating reasonable grounds therefor, which
petition may be in the form of a supplement to an approved new-drug applica-
tion. Upon receipt of such a petition, or on his own initiative at any time, the
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 43 of 49
41
Commissioner will publish a notice of proposed rule making and invite written
comments. After consideration of all available data, including any comments
submitted, the Commissioner may issue a regulation granting or refusing the
exemption[.] Whenever the Commissioner concludes… that granting or refus-
ing the exemption requires a more thorough development of the facts than is
possible in a written presentation, he may call a public hearing for that pur-
pose…. As soon as practicable after the completion of the hearing, the final
regulation granting or refusing the exemption shall be issued[.]
21 C.F.R. §130.101(b) (1964) (Pls.’ Opp’n Ex. 5); accord 21 C.F.R. §1.108(c) (1955) (Pls.’
Opp’n Ex. 6); accord 21 C.F.R. §310.200(b) (1976) (Pls.’ Opp’n Ex. 7). Thus, from 1954
through 1976 at least, FDA’s current interpretation of current §310.200(b) would have been un-
tenable.
Before they can hold FDA to its initial regulatory interpretation of §503(b)(1),
§503(b)(3), and §310.200(b), Plaintiffs must establish first that former §130.101 is current
§310.200 and second that any intervening amendments did not change FDA’s initial interpreta-
tion. Both tasks are quite easy. First, when it recodified its regulations in 1974, FDA plainly des-
ignated “Old section” §130.101 as “New section” §310.200. 39 Fed. Reg. 11,680 (Mar. 29,
1974) (Pls.’ Opp’n Ex. 8). Second, since then, FDA has adopted only one substantive amend-
ment to §310.200(b), as part of its rulemaking in the mid-1970s to adopt its uniform rules of ad-
ministrative practice. 40 Fed. Reg. 40,682, 40,769 (Sept. 3, 1975) (proposed amendment to
§310.200(b)); 42 Fed. Reg. 4680, 4714 (Jan. 25, 1977) (promulgated amendment to
§310.200(b)).19 As FDA’s rulemaking record demonstrates, adopting the uniform rules for ad-
19 In a 1977 recodification, FDA amended §310.200(b) to change the reference from the
original rules of practice (former 21 C.F.R. pt. 2) to the recodified ones (current 21 C.F.R. pt.
10). 42 Fed. Reg. 15,673, 15,674 (Mar. 22, 1977) (“Section 310.200(b) is amended by changing
the reference to ‘Part 2’ to read ‘Part 10’”). Technical amendments in 2007 changed citations to
§505(b)(1)(C) to the now-current §505(b)(1)(B). 72 Fed. Reg. 15,043 (Mar. 30, 2007).
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 44 of 49
42
ministrative practice did not alter the type of administrative action required to remove drugs
from the Rx requirements of §503(b)(1). Instead, the notice of proposed rulemaking merely pro-
vided that “Section 310.200(b) would be revised to replace the procedure now set out in that
provision with a reference to Part 2.” 40 Fed. Reg. at 40,716 (Pls.’ Opp’n Ex. 9). The mere eli-
mination of §310.200(b)’s rulemaking process in deference to the new general-purpose Part 2
process does not suggest a sub silentio intent to do away with rulemakings altogether. U.S. v.
Wilson, 290 F.3d 347, 359-60 (D.C. Cir. 2002) (drafter “unlikely to intend any radical departures
from past practice without making a point of saying so”). Henceforth, FDA would simply con-
vene §503(b)(3)’s required rulemakings under the general provisions of Part 2, not the specific
provisions of §310.200(b).
FDA’s rulemaking to add §310.200(e) on OTC-panel procedures confirms that, in 1976,
FDA interpreted §310.200(b) consistently with the statute (and opposite its current position):
[T]he Commissioner described the two procedures by which a prescription
drug ingredient may lawfully be marketed for OTC use. Ingredients limited to
prescription use under section 503(b)(1)(C) of the [FFDCA] may acquire OTC
status by a petition submitted pursuant to the procedures set forth in § 310.200
[]; the OTC drug review process provides another procedure.
41 Fed. Reg. 32,580, 32,581 (Aug. 4, 1976) (citations omitted). As indicated, “the procedures set
forth in § 310.200” clearly contemplated that FDA would act “by regulation,” even if the “peti-
tion” came to FDA in the form of an SNDA or if FDA acted on its own initiative. 21 C.F.R.
§310.200(b) (1976). Moreover, the regulations expressly and currently limit Rx-to-OTC switch-
es to §310.200(b)’s petition process or and §330.13’s monograph process: “Any drug limited to
prescription use under section 503(b)(1)(B) of the act remains so limited until it is exempted as
provided in paragraph (b) or (e) of this section.” 21 C.F.R. §310.200(a). To change either its in-
terpretation of its regulation (i.e., to switch the required procedures from a regulation to an or-
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 45 of 49
43
der) or its regulations themselves, FDA would need to undertake a rulemaking. 21 C.F.R.
§10.85(d)(1), (e); Motor Veh. Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42
(1983) (course change requires reasoned analysis beyond that required to act in the first in-
stance); Duramed Mot. at 42 (“As to a substantive regulation, an agency may change its interpre-
tation only by notice and comment where the change would constitute an amendment of the reg-
ulation”) (emphasis in original). FDA has not taken any lawful final action to amend its proce-
dures.
B. Count IV: Unlawful “Behind the Counter” Product. Prior to 1951, FDA distin-
guished between Rx and OTC drugs by regulation. In 1951, Congress enacted the Durham-
Humphrey Amendments as a “remedial” measure “in the sense that they are intended to protect
the public.” S. REP. 946, 82nd Cong., 1st Sess., at 3 (Oct. 12, 1951). Congress intended both “to
protect the public from abuses in the sale of potent prescription drugs” and “to relieve retail
pharmacists and the public from burdensome and unnecessary restrictions on the dispensing of
drugs safe for use without the supervision of a physician.” S. REP. 946, at 1; accord H.R. REP.
700, 82nd Cong., 1st Sess., at 2 (Jul. 16, 1951). The BTC category falls impermissibly between
the Durham-Humphrey Amendments’ Rx-OTC dichotomy. Although the statutory Rx-OTC di-
chotomy seeks “to eliminate much confusion and dissatisfaction caused by ambiguities in the
present provisions of the act,” S. REP. 946, at 2, FDA now seeks to restore that confusion by
creating a BTC category, without ensuring the safety provided by medical supervision.20
20 An OTC drug’s safety for use without medical supervision means safe in the “ordinary
meaning.” S. REP. 946, at 4. The definition of “safe” includes “other potentialities for harmful
effect… and the collateral measures that may be necessary in order to use the drug safely,” and
the definition “clearly shows that toxicity is only one factor to be considered by the courts in de-
termining whether a particular drug is safe for use without medical supervision.” Id. Congress
(Footnote cont'd on next page)
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 46 of 49
44
FDA has no such authority. Instead, FDA must approve or disapprove drug applications
based only on the “conditions prescribed, recommended, or suggested in the [drug’s] labeling,”
21 U.S.C. §355(d), and FDA cannot go beyond the labeling (i.e., the label and the written or
graphic materials accompanying the product, 21 U.S.C. §321(m)). FDA a fortiori cannot premise
a drug approval or drug safety on a drug manufacturer’s unenforceable promises. Indeed, under
administrations as diverse as those of Presidents Reagan, G.H.W. Bush, and Clinton, FDA has
reasoned that it lacks such authority. See General Accounting Office, Nonprescription Drugs:
Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated, App. I, at 83-84
(GAO/PEMD-95-12 Aug. 1995). Nothing has happened to change that.
C. Count VIII: Unlawful Exhaustion Regulations. As explained in Section II.B, supra,
FDA’s exhaustion regime (which this Court appears to have found “jurisdictional,” Op. at 6)
lacks statutory authority and fails to holding the contested agency action inoperative during in-
tra-agency appeals. As applied and facially, that exhaustion regime is unlawful. 5 U.S.C. §704.
IV. COURT SHOULD FILE AMENDED COMPLAINT
Plaintiffs argue that analyzing their complaint under their view of the merits will cure the
bases that the Court cited for dismissing this action. Even if the Court does so, Plaintiffs none-
theless would ask to amend their complaint to include the newly discovered evidence (not avail-
able to Plaintiffs until January 23, 2008) that Senator Clinton conditioned the release of her hold
on Plan B’s OTC approval, SAC ¶79, which implicates Rules 15(a) and 60(b)(2). Further, while
(Footnote cont'd from previous page.)
intended “this broad language… to comprehend all drugs that in fact should be administered un-
der medical supervision in order to [e]nsure their safe use,” S. REP. 946, at 9 (emphasis added),
and to include “drugs that are too dangerous, or otherwise unsuitable, to be used by a layman
without medical diagnosis or supervision.” H.R. REP. 700, at 7 (emphasis added).
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 47 of 49
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Plaintiffs consider it error (and so advised the Court) to rule on the contents of the administrative
record based on the parties’ representations, Pls.’ Opp’n at 4-5, 35-36; Am. Bioscience, Inc. v.
Thompson, 243 F.3d 579, 582 (D.C. Cir. 2001), it qualifies as mistake (the Court’s or Barr’s) to
accept Barr’s misrepresentation on Plaintiffs’ (and other parties’) arguments to FDA, thus impli-
cating Rules 59(e), 60(b)(1) and (b)(3), as well as surprise and excusable neglect (Plaintiff’s and
their counsel’s), based on a credible reading of the law of this Circuit, a pending motion to certi-
fy the record, illness, and waiting for Defendants to respond to Plaintiffs’ inquiry under Local
Rule 7(m), thus implicating Rule 60(b)(1). Moreover, if Plaintiffs indeed lack standing, the me-
rits component of the dismissal is void, implicating Rule 60(b)(4). The post-pleading amendment
of PREA triggers Rule 15(d) and Rule 60(b)(1) because not even FDA (which had an obligation
to disclose the issue) noticed the amendment’s relevance here. Finally, the bolstered pleading of
the ultra vires arguments included in Plaintiffs’ opposition trigger Rule 15(b), which allows post-
judgment amendments without re-opening the case. Finally, because the standing dismissal es-
sentially constitutes a merits dismissal (without even analyzing the issue), the Court should grant
Rule 59(e) relief. Ciralsky, 355 F.3d at 669; Caribbean Broadcasting, 148 F.3d at 230-31.
CONCLUSION
For the foregoing reasons, the plaintiffs respectfully request that the Court amend and al-
ter its judgment by entering the proposed order to grant Plaintiffs merits relief on Counts II, IV,
and VI and to vacate the approval of the SNDA for Plan B.
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 48 of 49
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Dated: March 18, 2008 Respectfully submitted,
/s/ Lawrence J. Joseph
Lawrence J. Joseph, D.C. Bar No. 464777
1250 Connecticut Ave., NW, Suite 200
Washington, DC 20036
Telephone: (202) 669-5135
Telecopier: (202) 318-2254
Counsel for Plaintiffs
Case 1:07-cv-00668-JDB Document 45 Filed 03/18/2008 Page 49 of 49
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
ASSOCIATION OF AMERICAN PHYSICIANS
& SURGEONS, INC., et al.,
Plaintiffs,
v.
FOOD & DRUG ADMINISTRATION, et al.,
Defendants,
and
DURAMED PHARMACEUTICALS, INC.,
Defendant-Intervenor.
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Civil Action No. 07-0668-JDB
[PROPOSED] ORDER
On considering the plaintiffs’ “Motion to Alter and Amend Judgment, for Judgment on
Partial Findings, for Reconsideration of Dismissal, and for Leave to Filed Amended and Sup-
plemental Complaint,” the briefs filed in support and opposition thereto, and the entire record
herein, the Court finds that plaintiffs’ motion is well taken. For the foregoing reasons, it is here-
by
ORDERED pursuant to Rule 59(e) that plaintiffs’ motion is granted; and it is
FURTHER ORDERED that Defendants’ motions to dismiss are denied; and it is
FURTHER ORDERED that the judgment is entered for plaintiffs and against the feder-
al defendants and Duramed pursuant to FED. R. CIV. P. 52(c) on Counts II, IV, and VI of the First
Amended Complaint; and it is
FURTHER ORDERED pursuant to Rule 15(a), (b), and (d) that leave to file the Second
Amended Complaint is granted; and it is
FURTHER ORDERED pursuant to Rule 52(c) that the following declaratory judgment
is entered against the federal defendants and Duramed:
Case 1:07-cv-00668-JDB Document 45-2 Filed 03/18/2008 Page 1 of 3
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(a) FDA and its Commissioner lack the authority to approve the same drug product for si-
multaneous OTC-Rx distribution under the same labeling (Second Am. Compl.
¶142(A)(iv));
(b) Any drug product labeled for simultaneous OTC-Rx distribution is misbranded (Second
Am. Compl. ¶142(A)(v));
(c) Under 21 C.F.R. §310.200(b) and 21 U.S.C. §353(b)(3), FDA must conduct a rulemaking
to exempt a new drug from Rx requirements of 21 U.S.C. §353(b)(1) (Second Am.
Compl. ¶142(A)(xiii)); and
(d) FDA lacks statutory authority to create or approve a drug for “behind-the-counter” distri-
bution as a discrete category of drug that is neither Rx-only nor fully OTC (Second Am.
Compl. ¶142(A)(x)); and it is
FURTHER ORDERED pursuant to Rule 52(c) that the following injunctive relief is en-
tered against the federal defendants and Duramed:
(a) The federal defendants’ approval of the Supplemental New Drug Application number 2l-
045/S011 for levonorgestrel tablets, 0.75 mg (“Plan B”) dated August 24, 2006, is va-
cated (Second Am. Compl. ¶142(B)(i)); and
(ii) The federal defendants are enjoined from approving any subsequent version of that or
any related Supplemental New Drug Application or New Drug Application for OTC dis-
tribution unless such approval is fully consistent with the declaratory relief rendered
herein (Second Am. Compl. ¶142(B)(ii)); and it is
Dated: ______________________, 2008
UNITED STATES DISTRICT JUDGE
Case 1:07-cv-00668-JDB Document 45-2 Filed 03/18/2008 Page 2 of 3
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Copy to:
LAWRENCE J. JOSEPH
1250 Connecticut Ave., NW, Suite 200
Washington, DC 20036
Telephone: (202) 669-5135
Telecopier: (202) 318-2254
Counsel for Plaintiffs
JANE M. LYONS
Assistant United States Attorney
555 Fourth St., N.W. - Room E4822
Washington, D.C. 20530
Telephone: (202) 514-7161
Telecopier: (202) 514-8780
Counsel for Federal Defendants
RICHARD M. COOPER
ANA C. REYES
WILLIAMS & CONNOLLY LLP
725 Twelfth Street, N.W.
Washington, DC 20005
Telephone: (202) 434-5466
Telecopier: (202) 434-5470
Counsel for Defendant-Intervenor
Case 1:07-cv-00668-JDB Document 45-2 Filed 03/18/2008 Page 3 of 3
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UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
ASSOCIATION OF AMERICAN
PHYSICIANS & SURGEONS, INC.,
1601 N. Tucson Blvd., Suite 9,
Tucson, AZ 85716,
CONCERNED WOMEN FOR AMERICA,
1015 Fifteenth St. NW, Suite 1100,
Washington, DC 20005,
FAMILY RESEARCH COUNCIL,
801 G Street, NW
Washington, DC 20001,
and
SAFE DRUGS FOR WOMEN,
1015 Fifteenth St. NW, Suite 1100,
Washington, DC 20005,
Plaintiffs,
v.
FOOD & DRUG ADMINISTRATION,
5600 Fishers Lane
Rockville, MD 20857,
ANDREW C. VON ESCHENBACH,
COMMISSIONER OF FOOD & DRUGS,
5600 Fishers Lane
Rockville, MD 20857,
in his official and individual capacities,
and
UNITED STATES OF AMERICA,
Defendants,
and
DURAMED PHARMACEUTICALS, INC.
400 Chestnut Ridge Road
Woodcliff Lake, NJ 07677,
Defendant-Intervenor.
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Civil Action No. 07-0668-JDB
SECOND AMENDED AND SUPPLEMENTED COMPLAINT
FOR DECLARATORY AND INJUNCTIVE RELIEF
Case 1:07-cv-00668-JDB Document 45-3 Filed 03/18/2008 Page 1 of 47
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Plaintiffs Association of American Physicians and Surgeons, Inc. (“AAPS”), Concerned
Women for America (“CWA”), Family Research Council (“FRC”), and Safe Drugs for Women
(“SDW”) seek declaratory and injunctive relief based on the following allegations.
NATURE OF THE ACTION
1. Plaintiffs bring this action to enforce the Federal Food, Drug, and Cosmetic Act
(“FFDCA”), the Administrative Procedure Act (“APA”), and the Due Process Clause of the Fifth
Amendment by vacating the approval in NDA 21-045/S-011 (hereinafter, “Plan B Approval
Order”) by Defendants Food and Drug Administration (“FDA”) and von Eschenbach of a
supplemental new drug application for levonorgestrel tablets, 0.75 mg (hereinafter “Plan B”), as
an over-the-counter (“OTC”) drug for women 18 and older and a prescription (“Rx”) drug for
girls under 18.
2. As set forth more fully in Paragraph 142, Plaintiffs seek the following injunctive
and declaratory relief:
(a) Vacate Defendants’ approval of Plan B for OTC distribution;
(b) Declare that Defendants FDA and von Eschenbach lack authority to
approve the same drug product for simultaneous OTC-Rx distribution;
(c) Declare that Defendants FDA and von Eschenbach lack authority to
bifurcate a drug product’s OTC versus Rx status based on the patient’s age;
(d) Declare that Defendants FDA and von Eschenbach lack authority to create
a hybrid “third class” of behind-the-counter drug beyond FFDCA’s OTC and Rx classes;
(e) Declare that Defendants failed to conduct the required rulemakings
necessary to authorize OTC distribution of Plan B;
(f) Declare that Defendants FDA and von Eschenbach unlawfully approved
Case 1:07-cv-00668-JDB Document 45-3 Filed 03/18/2008 Page 2 of 47
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Plan B for OTC distribution under improper pressure from two U.S. Senators; and
(g) Declare that Defendants FDA and von Eschenbach lack the authority to
impose mandatory administrative procedures that the public must exhaust before seeking
judicial review of (and interim injunctive relief against) unlawful final agency action.
PARTIES
3. Plaintiff AAPS is a not-for-profit membership organization incorporated under
the laws of Indiana and headquartered in Tucson, Arizona. AAPS’ members include thousands
of physicians nationwide in all practices and specialties, but primarily in small and solo
practices. AAPS was founded in 1943 to preserve the practice of private medicine, ethical
medicine, and the patient-physician relationship. AAPS members include more than 100
obstetricians and gynecologists who practice medicine in states where only a physician lawfully
may prescribe a prescription drug.
4. Plaintiff CWA is a nonprofit corporation formed under the laws of the District of
Columbia and headquartered there. CWA represents approximately 500,000 women and men in
50 states across the nation. CWA represents their interests before Congress and before federal,
state, and international governmental bodies on issues of specific interest to women. CWA has
been active in reproductive issues for over 25 years.
5. Plaintiff FRC is a nonprofit corporation formed under the laws of the District of
Columbia and headquartered there. FRC is dedicated inter alia to valuing human life from
conception until natural death and upholding the institution of the family, including parental
oversight of children’s health care. FRC has been active in reproductive issues for over 25 years.
6. Plaintiff SDW is a nonprofit corporation formed under the laws of the District of
Columbia and headquartered there. SDW is dedicated inter alia to rational and safe health-care
Case 1:07-cv-00668-JDB Document 45-3 Filed 03/18/2008 Page 3 of 47
4
policies. Through its members and its members’ members (collectively, “SDW Members”),
SDW represents thousands of health-care professionals (including nurses, physicians, and
pharmacists) and consumers nationwide. In particular, SDW Members include more than a
thousand pharmacists and more than two thousand obstetricians and gynecologists in virtually
every state, including more than 1,000 obstetricians and gynecologists who practice medicine in
states where only a physician lawfully may prescribe a prescription drug.
7. Defendant FDA is an agency within the U.S. Department of Health and Human
Services (“HHS”), an executive department of the United States government. Defendant von
Eschenbach is FDA’s Commissioner. Defendant von Eschenbach is sued both in his official
capacity and in his individual capacity under color of legal authority for actions unlawfully taken
and not taken by him and by those under his control. Defendant von Eschenbach is not sued in
his individual capacity for monetary or punitive damages. As FDA Commissioner, Defendant
von Eschenbach has the ultimate responsibility for FDA’s activities, including the complained-of
actions here. Defendant United States of America is the federal sovereign.
8. Defendant Intervenor Duramed Pharmaceuticals, Inc. (“Duramed”) is a wholly
owned subsidiary of Barr Pharmaceuticals, Inc. (“Barr”). Duramed Research, Inc. is wholly
owned subsidiary of Barr and/or Duramed. The Barr and Duramed entities worked jointly on
seeking OTC approval of Plan B and own the Plan B product line. This Court granted Duramed’s
motion to intervene as of right under FED. R. CIV. P. 24(a)(2). This Court did not grant
Duramed’s alternate motion for permissive intervention under FED. R. CIV. P. 24(b)(2).
JURISDICTION AND VENUE
9. This action arises out of Defendants’ ongoing FFDCA, APA, and Due-Process
violations and, therefore, raises federal questions over which this Court has jurisdiction pursuant
Case 1:07-cv-00668-JDB Document 45-3 Filed 03/18/2008 Page 4 of 47
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to: 28 U.S.C. §1331; the Acts of March 3, 1863, 12 Stat. 762, and June 25, 1936, 49 Stat. 1921
(as amended); D.C. Code §11-501; and this Court’s equity jurisdiction.
10. Defendants’ unlawful approval of the Supplemental New Drug Application
(“SNDA”) for Plan B’s dual OTC-Rx distribution and their taking that action without convening
the required rulemaking proceedings are final agency actions. First, Defendants’ SNDA
consummates the FFDCA decisionmaking process on the approvability of that SNDA and its
compliance with all applicable legal requirements. Second, that approval establishes the
obligations of pharmacists, alters the legal regime applicable to pharmacists, physicians, and
their patients by allowing access to Plan B without prescription, and denies female patients (and
doctors and pharmacists) their rights under the FFDCA. In particular, in those states where only
physicians lawfully may prescribe prescription drugs, the OTC approval of Plan B authorizes
pharmacists to distribute Plan B, which distribution would be unlawful in those states in the
absence of Defendants’ action approving Plan B for OTC distribution.
11. Pursuant to 28 U.S.C. §1391(e), venue is proper in the District of Columbia.
Under 5 U.S.C. §703, venue is proper in any court of competent jurisdiction.
12. Duramed and Barr maintain an office in the District of Columbia. Through its
counsel, Defendant-Intervenor Duramed voluntarily entered an appearance and moved to
intervene in this action, which provides this Court with personal jurisdiction over Duramed.
13. Defendant-Intervenor Duramed has expressed the desire to air its “serious[]
disagree[ment with FDA] about the safety and effectiveness of Plan B for OTC use by women 17
and younger” if this action proceeds to the merits. In essence, Duramed would ask this Court to
amend Defendants’ dual Rx-OTC approval of Plan B into an across-the-board OTC approval of
Plan B, notwithstanding that Duramed’s SNDA (as amended) did not request an across-the-board
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OTC approval for Plan B and Duramed did not challenge Defendants’ finding that Plan B is not
safe for OTC distribution to minors. The FFDCA puts on Duramed the burden to prove Plan B’s
safety through the submission of data to FDA to justify Duramed’s OTC position, 21 U.S.C.
§355(a)-(b), and requires Defendants to deny an NDA or SNDA if the submission does not
include adequate data to demonstrate safety and efficacy, 21 U.S.C. §355(c)(1), (d)(1), (2), (4).
Further, the FFDCA provides Duramed an opportunity to obtain administrative and judicial
review (in an appropriate U.S. Court of Appeals, not a U.S. District Court) of adverse FDA
decisions in “not approvable letters” on an NDA or SNDA, 21 CFR §314.120(a)(3); 21 U.S.C.
§355(h). The foregoing opportunities for administrative and judicial review constitute not only
an adequate alternate remedy that requires exhaustion, but also a “special statutory review
proceeding,” within the meanings of 5 U.S.C. §704 and 5 U.S.C. §703, respectively. This Court
lacks subject-matter jurisdiction over Duramed’s separate dispute with Defendants over Plan B’s
safety and efficacy for girls under 18 years of age.
14. An actual and justiciable controversy exists between Plaintiffs and Defendants.
PLAINTIFFS’ STANDING
15. The individual members of Plaintiffs and the individual members of Plaintiffs’
institutional members (collectively, “Plaintiffs’ Members”) include women and parents of girls
who would consider taking (or having their minor girl take) Plan B specifically or wish to review
and compare contraceptive options generally. Such Plaintiffs’ Members include women and
parents of girls who reside in states where only physicians lawfully can prescribe an Rx drug.
Plaintiffs’ Members also include physicians, obstetricians, and gynecologists, some of whom
reside in virtually every state where only physicians lawfully can prescribe an Rx drug.
Plaintiffs’ Members also include pharmacists – both as pharmacy employees and as pharmacy
Case 1:07-cv-00668-JDB Document 45-3 Filed 03/18/2008 Page 6 of 47
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owner-operators – who practice in virtually every state, including states that compel pharmacies
and pharmacists to carry and dispense Plan B, including without limitation Connecticut,
Washington, and Illinois.
16. To the extent that they relate to third parties (as distinct from Plaintiffs and
Plaintiffs’ members), the allegations of injury (Paragraphs 17-33) are made on the basis of
information and belief, formed after reasonable inquiry, which likely could be proved
conclusively after a reasonable opportunity for discovery.
Ongoing Injuries to FFDCA-Granted Right to Information and to Safe and Effective Drugs
17. Plaintiffs’ Members who are prospective consumers of Plan B or who wish to
compare it with analogous drugs, physicians and their patients who may wish to consume Plan B
or compare it with analogous drugs, and pharmacists who may dispense Plan B OTC or review
its labeling to respond to customers’ requests would benefit from Plan B labeling that is free of
false and misleading comparisons and from directions for use that clearly reflected the
limitations of Plan B’s safety and efficacy. Such Plaintiffs’ Members have an FFDCA-granted
right to such drug labeling information, which Defendants’ Plan B Approval Order denies to
them. Unless the Court vacates Defendants’ Plan B Approval Order, Plaintiffs’ Members and
(for those who are physicians or pharmacists) their patients and customers will not receive the
FFDCA-required information and warning label statements (including the information addressed
in Paragraph 58) and run the risk of using Plan B without an appreciation of the limitations in
Plan B’s safety and efficacy and its comparability with analogous drugs.
18. By purchasing Plan B OTC from a pharmacy, without consulting a physician,
Plaintiffs’ Members who are potential Plan B consumers, as well as the patients of Plaintiffs’
Members who are physicians in states where only a physician can write a prescription for an Rx-
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only drug, will fail to receive critical health-care protection as the result of foregoing doctor
visits previously required for contraceptives. First, by obtaining Plan B over the counter, these
women will forego direct medical advice about drug interactions, including those drugs indicated
on Plan B’s labeling, and medical screening for medical contraindications for the known and
expected risks of oral contraceptives. Second, the office visit associated with a woman’s seeking
a contraceptive prescription typically provides a critical opportunity for not only counseling
about the various health risks associated with sexual activity, but also medical screening (e.g.,
pap smear; breast-cancer screening; mammograms for women over 40; sexually transmitted
diseases; cervical cancer; human papilloma virus prevention; cholesterol, blood pressure, and
other cardiovascular screening). By foregoing the office visit associated with obtaining
contraceptive prescriptions, these Plan B consumers will worsen their overall health care.
19. FDA has acknowledged in its rulemaking preambles in the Federal Register that
the FFDCA requires labeling for the benefit of physicians (and other dispensers such as
pharmacists and nurses) and consumers, see, e.g., 43 Fed. Reg. 4214, 4213 (1978); 44 Fed.
Reg. 37,434, 37,435-36 (1979), and those FDA preambles (like FDA rulemaking preambles
generally) are binding on FDA under 21 U.S.C. §10.85(d)(1), (e).
Physicians’ Ongoing Competitive and Economic Injuries
20. For Plaintiffs’ Members who are physicians licensed to practice medicine in
states where only physicians lawfully may prescribe drugs that FDA has approved as
prescription drugs, the FDA order approving Plan B for OTC distribution to women 18 years and
older enabled pharmacists in their states to dispense Plan B without a physician’s prescription.
The relief requested in Paragraph 142 (e.g., vacatur of the Approval Order) would render such
pharmacists no longer able to dispense Plan B without a physician’s prescription and would
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render such competition unlawful.
21. As a direct result of FDA’s approval of Plan B for OTC distribution, the
physicians referred to in Paragraph 20 face exposure to competition from pharmacists (and an
increased number of competitors) in the contraceptive area of their medical practice. Both
existing patients and new patients who otherwise would have come to such physicians to obtain
a contraceptive prescription instead now can obtain Plan B directly from pharmacists, without
first visiting a physician’s office to obtain a prescription. As explained in Paragraph 18, such
physicians typically use an annual or periodic visit to renew a contraceptive prescription as the
opportunity to conduct other important medical counseling and screening. Although the amount
of money charged for such office visits varies with insurance and other factors, such office visits
involve a non-nominal financial benefit to such physicians.
Physicians’ Third-Party Standing to Assert Patients’ Rights
22. In addition to the concrete injuries alleged in Paragraphs 20-21, the Plaintiffs’
Members who are physicians referred to in Paragraph 20 also have standing to protect the
patient-physician relationship and their patients’ FFDCA-granted rights to adequate health care,
drug-labeling information, safe and effective drugs, and counseling on Rx drugs. These
physicians have close and confidential relationships with their patients. Moreover, because the
patients lack a formal understanding of the risks posed by foregoing medical screening and by
using Plan B without fully understanding the potential complications, these patients will neither
appreciate nor even recognize the risks posed or the preventative care and counseling foregone
by obtaining Plan B over the counter from a pharmacist, without consulting a physician.
23. Three factors hinder the patients and parents of patients of the Plaintiffs’
Members who are physicians referred to in Paragraph 20 from asserting and judicially enforcing
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their own rights. First, they are unaware of their injury because they tend to trust in the safety
inherent in government approval generally and FDA approval specifically. For that reason, they
typically neither appreciate nor even recognize the respects in which Plan B’s labeling is
deficient or in which Plan B is not safe and effective. Second, if they recognize Plan B’s various
limitations, their typical response is simply to refrain prospectively from purchasing Plan B or
relying on its label information. Third, even patients and parents of patients who believe that
Plan B’s labeling injures them have little incentive to sue because of the economic burdens of
litigation. Fourth, the emergency nature of an appropriate use of Plan B renders individual
consumers’ injuries from Defendants’ unlawful actions too speculative for such consumers to
bring suit for anything other than informational standing (and Plaintiff organizations can assert
informational standing in their own right as organizations). Because Defendants have abdicated
their responsibility to police women’s FFDCA rights and the rights-holders themselves lack the
knowledge and incentive to sue, physicians by default are the best available proponent of
women’s FFDCA rights.
Ongoing Injuries to Pharmacists
24. Congress intended the Durham-Humphrey Amendments on the Rx-OTC
dichotomy to provide clarity as to which products are Rx and which are OTC. By failing to
comply with the Durham-Humphrey Amendments’ provisions on the Rx-OTC dichotomy,
Defendants’ Plan B Approval Order subjects Plaintiffs’ Members who are pharmacists to
liability for holding for sale and selling a misbranded drug. Before such pharmacist members
take action both unlawful and unethical within their profession, they have the right to seek
declaratory and injunctive relief to ensure compliance with the legal and ethical requirements of
their profession. Pharmacist members who face pending or future enforcement actions by state
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boards of pharmacies for failing to comply with state-law requirements to dispense Plan B would
benefit from the relief requested in Paragraph 142 because any such requirement to dispense dual
Rx-OTC Plan B would be preempted by the Supremacy Clause because such drugs are
misbranded when held for sale under federal law.
25. Plaintiffs’ Members include practicing pharmacists – licensed to practice in states
where only physicians can prescribe an Rx drug – who face expanded legal liability from the
removal of the otherwise-applicable protections afforded to pharmacists who dispense an Rx
drug pursuant to a physician’s prescription. In many such states in which Plaintiffs’ Members
practice, pharmacists enjoy immunity from tort liability for correctly filling a physician’s
prescription. By replacing physicians with pharmacists in Plan B’s distribution scheme,
Defendants’ Plan B Approval Order eliminates that immunity and exposes pharmacists to tort
liability.
26. Plaintiffs’ Members include practicing pharmacists – licensed to practice in states
where only physicians can prescribe an Rx drug – who as the direct result of Defendants’
unlawful approval of Plan B face added expense and administrative burdens in their practice of
their profession via requirements not applicable to either OTC or Rx drugs. Under Plan B’s OTC
distribution scheme under the “CARE” program, such pharmacists must involve themselves
directly in sales that cashiers previously could handle. These transactions disrupt the otherwise-
normal flow of the pharmacists’ work, and (for Plaintiffs’ Members who are salaried
pharmacists) increase their workload without increasing their compensation.
27. Plaintiffs’ Members include practicing pharmacists – licensed to practice in states
where only physicians can prescribe an Rx drug – who as the direct result of Defendants’
unlawful approval of Plan B are subject to compelled speech to further a customer’s use of Plan
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B and to violation of these pharmacists’ conscience-based objections to Plan B. Prior to the
approval of Plan B for OTC distribution under the “CARE” program, such pharmacists could
allow pharmacist colleagues to fill prescriptions, on other shifts if necessary, and could allow
non-pharmacist cashiers to provide the product to customers. Under the OTC regime that
Defendants have approved, however, such pharmacists now often must directly involve
themselves in sales of Plan B (such as when only one pharmacist is on duty), in violation of their
conscience-based objections to Plan B.
Procedural Injuries
28. Plaintiffs AAPS, FRC, and CWA and SDW Members commented on the
Defendants’ Advance Notice of Proposed Rulemaking (“ANPRM”) on the novel legal issues
presented by Plan B’s Rx-OTC switch, and Plaintiffs and their members wished to comment and
would have commented in subsequent rulemaking proceedings, if Defendants had convened
them. If the Court grants the relief requested in Paragraph 142, and Defendants initiate a
rulemaking to effect an Rx-OTC switch for Plan B, Plaintiffs and their members would comment
in that rulemaking proceeding. By taking the complained-of actions without the rulemaking
proceedings required by the APA and FFDCA, Defendants denied Plaintiffs and their members’
procedural rights conferred by Congress.
29. To the extent that the FFDCA citizen-petition regulations impose a mandatory
administrative process that the public must exhaust before challenging unlawful final agency
action, that administrative process deprives Plaintiffs and Plaintiffs’ members of the venue of
their choosing and imposes additional costs and delay, which are not recoverable, even if
Plaintiffs or Plaintiffs’ members ultimately prevail via the Defendants’ granting a citizen petition
or via a successful litigation challenge to the denial of a citizen petition.
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30. In addition to the procedural injuries in Paragraphs 28-29, Plaintiffs and their
members suffer concrete injuries to their interests, see Paragraphs 17 to 27, which fall within the
zone of interests of the relevant statutes, see Paragraphs 31-33. Accordingly, Plaintiffs have
procedural standing, which relaxes the showings required for immediacy and redressability.
Zone of Interests
31. The injuries to Plaintiffs’ Members satisfy the prudential zone-of-interests tests
because Congress acknowledged FFDCA’s Rx-OTC provisions benefit and effect pharmacists,
physicians, and consumers. See Paragraph 48. Moreover, the FFDCA’s labeling and pediatric-
data requirements benefit physicians, pharmacists, and consumers by facilitating their
performance of their jobs (physicians and pharmacists) and by ensuring that safe, effective, and
understandable drugs are available (consumers generally and pediatric subpopulations
specifically).
32. As a prudential test imposed by the judiciary, Congress can waive the zone-of-
interest test by conferring standing to anyone with constitutional standing. Although it is unclear
whether an administrative agency can waive the judiciary’s prudential concerns with the same
conclusiveness as can the Congress, this Court should waive its prudential concerns because
Defendant FDA has waived standing as a general defense. See 40 Fed. Reg. 40,689 (Sept. 3,
1975) (“It is the opinion of the Commissioner that every citizen has standing in the courts to
contest any action of the agency, and that no objection relating to such standing will be
interposed by the agency in such cases”) (proposed rule); 42 Fed. Reg. 4688 (Jan. 25, 1977)
(“commenters specifically commended the Commissioner’s decision not to raise a lack of
‘standing’ as a basis for opposing review of agency decisions”) (final rule).
33. To the extent that Plaintiffs’ and their members are not the intended beneficiaries
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of the relevant statutes, physicians are suitable challengers in Counts II, III, and IV of FFDCA’s
restrictions on entry on the ability lawfully to provide access to Plan B (i.e., the ability to provide
a prescription to Rx-only Plan B versus the ability of pharmacists to dispense dual Rx-OTC Plan
B). Similarly, physicians, pharmacists, other health-care professionals, and consumers are
suitable challengers to the clear statutory demarcations at issue in Counts II, III, IV, V, VI, VII,
and VIII. Finally, to the extent that Defendants have acted ultra vires their authority, the
prudential zone-of-interests test does not apply to judicial review of ultra vires agency action.
SOVEREIGN IMMUNITY
34. Defendant United States has waived its sovereign immunity for actions against
the United States, its instrumentalities, and officers for non-monetary injunctive and equitable
relief and for the entry of judgments and decrees against the United States in such actions.
Defendant United States has waived sovereign immunity for this action and for the relief sought
in Paragraph 142.
35. With Defendant von Eschenbach named and served in his official and individual
capacities, sovereign immunity does not shield Defendant von Eschenbach’s ultra vires actions.
This Court possesses equity jurisdiction over federal officers derived both from the Court’s
enabling legislation and from the historic equity jurisdiction of Maryland courts over Maryland
officers, prior to Maryland’s ceding the District of Columbia as a federal enclave.
36. As a matter of historical fact, at the time that the states ratified the U.S.
Constitution, the equitable, judge-made doctrine that allows use of the sovereign’s courts in the
name of the sovereign to order the sovereign’s officers to account for their conduct (i.e., the rule
of law) was as least as firmly established and as much a part of the legal system as the judge-
made doctrine of federal sovereign immunity. See, e.g., Louis L. Jaffee, The Right to Judicial
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Review I, 71 HARV. L. REV. 401, 433 (1958). No act of Congress limits this Court’s equity
jurisdiction for an action against Defendant von Eschenbach’s ultra vires acts.
IRREPARABLE HARM AND INADEQUATE ALTERNATE REMEDIES
37. Plaintiffs’ action is not barred by the APA’s “adequate-remedy bar,” 5 U.S.C.
§704, or analogous equitable doctrines because neither FFDCA nor any other provision of law
provides an alternate legal remedy for Plaintiffs’ injuries.
38. Although neither the FFDCA nor the APA imposes any mandatory administrative
remedy that Plaintiffs must exhaust prior to initiating this action, Defendants and Defendant-
Intervenor Duramed have suggested the Defendants’ citizen-petition process constitutes an
alternate administrative remedy that requires exhaustion before commencing an action for
judicial review. To the extent that Defendant FDA’s citizen-petition regulation constitutes a
mandatory alternate remedy, that remedy is inadequate because
(a) Nothing requires the agency to convene a petitioned-for rulemaking, in
contrast to the APA- and FFDCA-required rulemakings covered by Counts V and VI;
(b) The administrative-petition process does not entitle petitioners to the
administrative record, in contrast to APA review on an administrative record;
(c) The petition process does not entitle a successful petitioner to recover
costs and attorneys fees, in contrast with the Equal Access to Justice Act;
(d) The standard of review for the denial of a petition is more deferential than
judicial review of final agency action;
(e) As a practical matter, the Defendants typically delay action on petitions
well past the 180-day deadline for action, thereby requiring petitioners to bear the delay
or incur the expense and burden of an action to compel unlawfully delayed agency action
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under the All Writs Act.
39. Because this Court has jurisdiction as a threshold matter, the Declaratory
Judgment Act, 28 U.S.C. §§2201-2202, provides this Court the power to “declare the rights and
other legal relations of any interested party…, whether or not further relief is or could be
sought.” 28 U.S.C. §2201; accord FED. R. CIV. P. 57 advisory committee note (“the fact that
another remedy would be equally effective affords no ground for declining declaratory relief”).
40. A plaintiff’s irreparable injury and lack of an adequate legal remedy justify
injunctive relief. In addition to the declaratory relief requested in Paragraph 142, Plaintiffs are
entitled to injunctive relief because (a) imminent and ongoing exposure to inadequate health
care, drug-labeling information, and counseling; unlawful competition; expanded legal liability,
expense, administrative burden, and compelled speech; and administrative delay constitute
irreparable injury; (b) as set forth in Paragraphs 37-38, Plaintiffs lack any alternate legal remedy
and any mandatory and adequate administrative remedy against Defendants’ FFDCA, APA, and
Due-Process violations.
41. Even if FDA lawfully could require a typical plaintiff to exhaust an intra-agency
petition before seeking judicial review, that exhaustion would be improper and futile here
because (a) Plaintiffs presented these arguments to FDA in their comments on an FDA Federal
Register notice, and Defendants FDA and von Eschenbach considered and rejected them when
deciding the action to take on the Plan B SNDA, (b) Defendant von Eschenbach testified to
Congress that the issues raised in response to the Federal Register notice did not prevent
Defendants’ proceeding with the unlawful dual Rx-OTC SNDA, and (c) Defendants’ merits
briefing in this Court establishes that they have predetermined the issues that Plaintiffs would
raise and that petitioning would be futile.
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STATUTORY BACKGROUND
Federal Food, Drug, and Cosmetics Act
42. Although FFDCA assigns the applicable duties to HHS and the HHS Secretary,
see 21 U.S.C. §321(c)-(d), the HHS Secretary has delegated the pertinent authorities to the FDA
and the FDA Commissioner.
43. FFDCA prohibits marketing and sale of a “new drug” unless it has been proven
safe and effective through approval of a new drug application (“NDA”) or supplemental new
drug application (“SNDA”), requiring the applicant to submit an extensive battery of analytical
tests, animal studies, and human clinical safety and efficacy trials. 21 U.S.C. §355(a)-(b).
44. FDA cannot lawfully approve an NDA or SNDA that fails even one of seven
FFDCA-specified “grounds for denying approval.” 21 U.S.C. §§355(c)(1), 355(d)(1)-(d)(7). If
one or more of the seven grounds applies, FDA “shall issue an order refusing to approve the
application.” 21 U.S.C. § 355(d).
45. In pertinent part, FDA must deny an NDA or SNDA if:
(1) the investigations, reports of which are required to be
submitted to the Secretary pursuant to subsection (b) of this section
[505], do not include adequate tests by all methods reasonably
applicable to show whether or not such drug is safe for use under
the conditions prescribed, recommended, or suggested in the
proposed labeling thereof[;]
(2) the results of such tests show that such drug is unsafe for use
under such conditions or do not show that such drug is safe for use
under such conditions[;]
***
(4) upon the basis of the information submitted to [FDA] as part of
the application, or upon the basis of any other information before
[FDA] with respect to such drug, [FDA] has insufficient
information to determine whether such drug is safe for use under
such conditions[;]
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*** [or]
(7) based on a fair evaluation of all material facts, such labeling is
false or misleading in any particular[.]
21 U.S.C. § 355(d)(1), (2), (4), (7).
46. A drug’s labeling is false or misleading per se if the drug is misbranded. A drug is
misbranded, inter alia, if its labeling or advertising fails to reveal material facts made material
by its labeling’s affirmative statements with respect to consequences that may result from the use
of the drug under the conditions of use prescribed in the labeling or advertising thereof or under
such conditions of use as are customary or usual. A drug is misbranded if its labeling bears both
the Rx-only and OTC legends. A drug is misbranded if the data supporting such SNDA or NDA
did not include data required by the Pediatric Research Equity Act.
Durham-Humphrey Amendments
47. Prior to the enactment of the Durham-Humphrey Amendments in 1951, FFDCA
addressed the distinction between Rx and OTC drugs by regulation. Congress enacted the
Durham-Humphrey Amendments as a “remedial” measure “in the sense that they are intended to
protect the public.” S. REP. 946, 82nd Cong., 1st Sess., at 3 (Oct. 12, 1951). Congress intended the
Durham-Humphrey Amendments both “to protect the public from abuses in the sale of potent
prescription drugs” and “to relieve retail pharmacists and the public from burdensome and
unnecessary restrictions on the dispensing of drugs safe for use without the supervision of a
physician.” S. REP. 946, at 1; accord H.R. REP. 700, 82nd Cong., 1st Sess., at 2 (Jul. 16, 1951).
48. The Senate Report indicates that “the bill, as amended, will serve to eliminate
much confusion and dissatisfaction caused by ambiguities in the present provisions of the act,
and will benefit drug manufacturers, retail druggists, medical practitioners, and the public.” S.
REP. 946, at 2. The House Report noted that the bill presented a dilemma between positions put
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forward by retail druggists and drug manufacturers. H.R. REP. 700, at 8. The National
Association of Retail Druggists advocated that “”vest[ing the agency] with the power to
determine [Rx status] on the basis of a statutory standard, but subject to judicial review” would
“achiev[e] the greatest possible certainty for retail druggists and the general public.” Id. The
drug manufacturers, by contrast, argued “that the determination of which drugs may be sold only
on prescription should be left to judicial determination” and “opposed the vesting of any such
authority in a Federal official.” Id. The House committee took the retail druggists’ position
“somewhat reluctantly because the committee [was] deeply conscious of the fact that the power
to determine which drugs are prescription drugs and which are over-the-counter drugs is one
which affects drug manufacturers, drug wholesalers, retail druggists, pharmacists, physicians,
and, last but not least, the general public.” H.R. REP. 700, at 9.
49. Under the Durham-Humphrey Amendments, as amended, FFDCA’s Rx-drug
requirements apply (a) to so-called “dangerous drugs,” and (b) to new drugs limited by an
approved NDA to use under the professional supervision of a practitioner licensed by law to
administer such drugs. 21 U.S.C. §353(b)(1)(A)-(B). The Durham-Humphrey Amendments
defined the former category to apply when a drug “because of its toxicity or other potentiality for
harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe
for use except under the supervision of a practitioner licensed by law to administer such drug.”
21 U.S.C. §353(b)(1)(A).
50. As used in the Durham-Humphrey Amendments, a drug’s safety for use without
medical supervision means safe in the “ordinary meaning.” S. REP. 946, at 4. The definition of
“safe” includes “other potentialities for harmful effect… and the collateral measures that may be
necessary in order to use the drug safely,” and the definition “clearly shows that toxicity is only
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one factor to be considered by the courts in determining whether a particular drug is safe for use
without medical supervision.” Id. Congress intended “this broad language… to comprehend all
drugs that in fact should be administered under medical supervision in order to [e]nsure their
safe use,” S. REP. 946, at 9, and to include “drugs that are too dangerous, or otherwise
unsuitable, to be used by a layman without medical diagnosis or supervision.” H.R. REP. 700, at
7 (emphasis added). In reviewing NDAs and SNDAs under those criteria, FDA not only can, but
also must and routinely does consider the potential for misuse as part of the drug’s safety.
51. Due to the Durham-Humphrey Amendments’ OTC-Rx distinction, FDA’s
labeling requirements for OTC and Rx differ significantly, beyond the mere absence or presence
of the “Rx Only” legend. Compare 21 C.F.R. pt. 201, subpt. C (OTC labeling) with id. subpt. B
(Rx labeling). The detail required for Rx labeling’s medical audience is inconsistent with the
brevity and clarity required for an OTC Drug Facts Panel’s lay audience.
52. When enacting the statutory OTC-Rx dichotomy in the Durham-Humphrey
Amendment, Congress expressly deemed the presence or absence of the Rx legend as mutually
exclusive for Rx and OTC products, respectively, and specifically wished to prohibit dual Rx-
OTC labeling. The Senate Report expressed this intent:
Paragraph (4) of the new subsection requires that, in addition to the
labeling requirements of prescription drugs specified in paragraph
(2) of the subsection, the interstate label on such drugs must bear
the statement “Caution: Federal law prohibits dispensing without
prescription.” On the other hand, over-the-counter drugs are
forbidden to bear a label containing this caution statement.
S. REP. 946, at 10 (emphasis added). FDA intended 21 C.F.R. §310.200(d) and its predecessors
to codify this Rx-OTC dichotomy by prohibiting the Rx legend on OTC products switched under
21 C.F.R. §310.200 and its predecessors. When amending §503(b)(4) in 1997 to replace the
Durham-Humphrey Amendment’s Rx legend (i.e., “Caution: Federal law prohibits dispensing
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without prescription”) with the current Rx legend (i.e., “Rx only”), Congress did not provide any
evidence that it relaxed the Durham-Humphrey Amendment’s mutual exclusivity of OTC and Rx
labeling.
53. For new drugs limited by an approved NDA to use under professional
supervision, the Durham-Humphrey Amendments allow FDA to exempt such drugs from the Rx
requirements by regulation “when such requirements are not necessary for the protection of the
public health.” 21 U.S.C. §353(b)(3); H.R. REP. 700, at 16.
54. FDA regulations and the FFDCA provide two (and only two) procedures for FDA
to effect an Rx-to-OTC switch. First, 21 C.F.R. §310.200(b) authorizes a rulemaking under 21
U.S.C. §353(b)(3) to remove the drug from the prescription requirements of 21 U.S.C.
§353(b)(1), based on FDA’s finding that the drug meets the Durham-Humphrey Amendments’
statutory standard for dangerous drugs and that the drug is safe and effective for use in self-
medication as directed in proposed labeling, provided that the resulting OTC product does not
bear Rx labeling. FDA did not conduct an Rx-to-OTC switch under this procedure and, indeed
the resulting dual Rx-OTC product did not “switch” Plan B to an OTC product. Second, 21
C.F.R. §330.13 allows Rx-to-OTC switches through OTC monograph proceedings. FDA did not
conduct an OTC monograph proceeding for Plan B.
55. Prior to its approval of Plan B for dual OTC-Rx distribution, FDA had interpreted
the statutory and regulatory OTC-Rx distinctions to allow marketing of the same active
ingredient in different drug products in the Rx and OTC markets based on a “meaningful
difference” between the two drug products. Prior to its approval of Plan B for dual OTC-Rx
distribution, FDA interpreted this meaningful-difference standard to include the five parameters
(namely, the product’s active ingredient, indication, strength, route of administration, and dosage
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form) across which FDA determined whether a meaningful difference existed between two drug
products. Prior to its approval of Plan B for dual OTC-Rx distribution, FDA has never approved
the same drug product for simultaneous Rx and OTC distribution.
Pediatric Research Equity Act
56. The Pediatric Research Equity Act (“PREA”) requires NDAs and SNDAs filed
after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing
regimen, or new route of administration to include an assessment and relevant data for each
relevant pediatric age group to enable FDA (a) to assess the drug’s safety and efficacy for the
claimed indications in all relevant pediatric subpopulations, and (b) to support dosing and
administration for each pediatric subpopulation for which the drug is safe and effective. 21
U.S.C. §355c(a)(2)(A)(i)-(ii). Of these two PREA criteria, the first criterion is limited to claimed
indications, and the second criterion is not limited to claimed indications. Id. A drug’s status as
OTC versus Rx constitutes an “indication” under FFDCA and PREA.
57. Congress patterned the Pediatric Research Equity Act on FDA’s prior Pediatrics
Rule, 63 Fed. Reg. 66,632 (Dec. 2, 1998). In promulgating its final rule, FDA accepted
comments that opposed the rigid age ranges of the proposed rule and adopted a flexible approach
that considers stages of development. 63 Fed. Reg. at 66,650-51. In addition to considering
pediatric populations aged up to 21 years old in its rulemaking, 63 Fed. Reg. at 66,651, the
Pediatrics Rule expressly covered adolescents as well as neonates, infants, and children. 63 Fed.
Reg. at 66,668 (former 21 C.F.R. §201.23(a)). Like FDA’s rule, PREA does not specify or define
rigid age ranges for covered pediatric subpopulations.
58. Under the 2007 amendments to PREA, which §402(b) of the 2007 amendments
would apply to Barr-Duramed’s PREA submissions if the Court grants the relief requested in
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Paragraph 142, FDA must make information available to the public (including without limitation
physicians, pharmacists, and consumers) via label changes and the FDA website. 21 USC
§355c(g)(2), (h)(1)-(2).
Citizen-Petition Regulation
59. FDA’s regulations provide the opportunity for any interested person to petition its
Commissioner to issue, amend, or revoke any FDA regulation or order or to take or refrain from
taking any agency action. 21 C.F.R. §10.25(a). The regulations further provide the opportunity
for any interested person to seek an administrative stay of any FDA action. 21 C.F.R. §10.35(b).
60. FDA’s regulations expressly provide that a manufacturer’s SNDA form under 21
C.F.R. §314.50 constitutes a petition under 21 C.F.R. §10.25(a)(1). The regulations define
an interested person as “a person who submits a petition or comment or objection… in an
informal or formal administrative proceeding,” 21 C.F.R. §10.3(a), and authorize FDA’s
Commissioner “[i]n reviewing a petition [to] use the following procedures… (3) A Federal
Register notice requesting information and views.” 21 C.F.R. §10.30(h)-(h)(3).
61. Although FDA lacks statutory authority to require administrative exhaustion, its
regulations provide that, before seeking judicial review of an FDA action or failure to act, an
interested party first must petition the Commissioner pursuant to §10.25(a) to take or refrain
from taking the relevant action or inaction. 21 C.F.R. §10.45(b). The regulations provide that no
administrative action by an interested person stays, delays, or otherwise holds inoperative any
FDA action. 21 C.F.R. §10.35(d). The regulations acknowledge that an interested person may
seek judicial review of a final agency action without first petitioning the Commissioner, except
that the regulations purport to restrict a litigant’s right to seek interim relief in court unless the
petitioner first sought an administrative stay pursuant to §10.35. 21 C.F.R. §10.45(e).
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Administrative Procedure Act
62. The APA requires executive agencies to conduct notice-and-comment rulemaking
when promulgating or amending certain rules. 5 U.S.C. §553(b)-(c). Although an initial
interpretation of a regulatory or statutory provision often is exempt from the notice-and-
comment requirements, 5 U.S.C. §553(b)(A), the APA nonetheless requires agencies to undergo
notice-and-comment rulemaking when amending a prior interpretation. In the absence of express
statutory authority to the contrary, an agency cannot delay judicial review of otherwise final
agency action by requiring exhaustion of intra-agency remedies unless the agency action is
rendered inoperative during the resolution of the intra-agency remedies. 5 U.S.C. §704.
FACTUAL BACKGROUND
63. Plan B’s active ingredient (levonorgestrel) is a synthetic progestogen hormone.
As used in Plan B, levonorgestrel is a non-food article intended to affect the function of female
humans’ bodies. Levonorgestrel is a “drug” within the meaning of 21 U.S.C. §321(g)(1).
64. Levonorgestrel was not subject to the Food and Drugs Act of June 30, 1906, on or
before June 25, 1938. Experts qualified by scientific training and experience to evaluate the
safety and effectiveness of drugs do not generally recognize levonorgestrel as safe and effective
for use under the conditions prescribed, recommended, or suggested by Plan B’s labeling.
Levonorgestrel has not been used to a material extent or for a material time under conditions
prescribed, recommended, or suggested by Plan B’s labeling. FDA approved the initial NDA for
Plan B on July 28, 1999, and an SNDA for Plan B on August 26, 2006. In light of the foregoing,
levonorgestrel is a “new drug” within the meaning of 21 U.S.C. §321(p).
FDA’s Division of Reproductive and Urologic Drug Products
65. As outlined in Paragraphs 66-70, the methodologies used and the workproduct
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prepared by the staff at Defendant FDA’s Reproductive Health Division diverge from accepted
scientific and regulatory methods.
66. In testing the safety of drugs related to reproductive health, Defendants consider
safety data on only healthy women, without considering other populations (e.g., overweight
women, smokers, adolescents) and without applying safety factors for intra-species variability.
Failure to consider these other populations can have serious – even deadly – results when
members of the excluded populations receive doses tested only on healthy populations.
67. For contraceptives and abortifacients, Defendants determine relative safety by
comparing the risk of a new drug or treatment with the risks of pregnancy (which include the
risks associated with not only abortifacients and abortions, but also those associated with
childbirth) instead of comparing the new drug or treatment with the risks of comparable
pharmaceutical and surgical treatments for preventing or terminating a pregnancy.
68. In addressing the safety of drugs like Plan B, the Defendants considered only
acute data (e.g., adverse reactions over five days to a week), without assessing chronic impacts,
and considered only single dosages (i.e., two .75 mg tablets or 1.5 mg), without considering the
impact of multiple doses per month or successive months of repeat use. Typically, where the
safety data for a drug covers only limited dosages to determine the drug’s health effects, the
labeling must provide warnings that limit use accordingly (e.g., “Do Not Use More than Once
per Month” or “Not Safe for Use More than Once a Month”).
69. In a Federal Register notice dated February 25, 1997, one of Defendant von
Eschenbach’s predecessors and Defendant FDA issued a blanket determination of safety and
efficacy for combined oral contraceptives taken up to 72 hours after unprotected intercourse and
containing a total of up to 0.12 mg. ethinyl estradiol and 0.60 mg. levonorgestrel. 62 Fed. Reg.
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8610, 8611 (1997). These blanket determinations are unprecedented and unsupported in FDA
practice. Because Plan B involves 0.75 mg levonorgestrel, the blanket determinations do not
apply directly to Plan B. Further, the data cited in the Federal Register notice do not establish
the safety or efficacy of Plan B under the standards identified in this Complaint for Declaratory
and Injunctive Relief.
70. Defendants have relied on historically controlled trials, rather than actively or
randomly controlled trials, to establish the safety of hormonal contraceptives. FDA’s review of
contraceptives does not present the “special circumstances” that could justify FDA’s use of
historically controlled trials. In deviating from the “gold standard” of actively or randomly
controlled trials, Defendants have failed to correct their departures with additional safety factors.
Approval of Plan B
71. On January 29, 1999, Women’s Capital Corp. (“WCC”) submitted the original
NDA for prescription Plan B. Just six months later, on July 28, 1999, FDA approved Plan B as a
“new drug” for Rx distribution.
72. In approving Plan B for Rx distribution in 1999, FDA granted a temporally
limited waiver of the then-applicable pediatric data requirements: “we are waiving the pediatric
study requirement for this application at this time.” Letter from Lisa D. Rarick, M.D., Center for
Drug Evaluation and Research, to Sharon Camp, Ph.D., Women’s Capital Corp., at 2 (Jul. 28,
1999) (emphasis added). By its express terms and as intended by FDA, the 1999 waiver did not
apply prospectively to future SNDAs for Plan B.
73. In an SNDA dated April 16, 2003, WCC sought an Rx-to-OTC switch for Plan B
for consumers of all ages. On or about February 26, 2004, Barr acquired WCC by stock purchase
and merged WCC into Barr’s subsidiary, Duramed. From the date of the merger, Barr, Duramed,
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and Duramed Research, Inc. (collectively, hereinafter “Barr-Duramed”) worked jointly on
seeking OTC approval of Plan B.
74. By correspondence dated May 6, 2004, Dr. Steven Galson – then the Acting
Director of the Center for Drug Evaluation and Research (“CDER”) – issued a “not approvable”
letter in response to the Plan B SNDA, citing Barr-Duramed’s failure to demonstrate that
adolescents under 16 could use Plan B without professional supervision by a practitioner
licensed to administer the drug. In addition to Barr-Duramed’s FFDCA-granted right to request a
hearing to challenge FDA’s not-approvable finding, Dr. Galson described two additional
options: (a) provide the data to demonstrate safety for the targeted adolescents, or (b) seek OTC
status only for women and girls 16 and over. Under the second option (which Barr-Duramed had
suggested), Dr. Galson advised Barr-Duramed that it bore the burden of demonstrating the lawful
implementation of a dual Rx-OTC distribution, which FDA would need to find consistent with
its statutory authority under FFDCA.
75. On July 21, 2004, Barr-Duramed filed an amended SNDA to retain Rx status for
girls under 16 and to confine the OTC switch to those 16 and over (i.e., Barr-Duramed declined
to fill the age-related gap in the safety data for Plan B). By letter dated August 26, 2005, the
FDA Commissioner (who then possessed the authority to make the approvable versus non-
approvable decision) advised Barr-Duramed that CDER found the scientific data sufficient to
support safe use only for women and girls aged 17 and older. The FDA Commissioner also
advised Barr-Duramed that FDA was unable to reach an approvability decision because of “three
difficult and novel issues” presented by Barr-Duramed’s age-bifurcated, dual Rx-OTC proposal:
(a) whether FDA should initiate a rulemaking to codify its interpretation of when FFDCA
permits simultaneous marketing, (b) whether FDA could enforce an age-related limitation for Rx
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vs. OTC sales, and (c) whether the FFDCA authorizes sale of the same drug in the same
packaging to both the Rx and OTC markets.
76. In conjunction with the correspondence dated August 26, 2005, FDA released an
ANPRM that sought public comment on the issues raised by the FDA Commissioner’s letter. See
70 Fed. Reg. 52,050 (2005). In its ANPRM, FDA set forth its consistent policy on the
“meaningful difference” necessary to distribute the same active ingredient as both OTC and Rx.
From the time Congress enacted the Durham-Humphrey Amendments through the date of the
ANPRM, FDA had adopted only that one, consistent policy on that “meaningful difference” test.
77. FDA received approximately 47,000 comments on its ANPRM, including
comments from Plaintiffs AAPS, CWA, and FRC that indicated that FDA must conduct a
rulemaking before approving Plan B’s dual Rx-OTC distribution. The comments to the ANPRM
constitute part of the administrative record for the challenged agency actions and inaction.
78. On or about March 15, 2006, U.S. Senators Hillary Clinton of New York and
Patty Murray of Washington – both members of the Senate’s Committee on Health, Education,
Labor and Pensions (“HELP”) – placed holds on that Committee’s consideration of Defendant
von Eschenbach (then FDA’s Acting Commissioner) for confirmation as FDA Commissioner.
Senators Clinton and Murray conveyed their holds to Defendants publicly and privately.
79. On the eve of his confirmation hearing before the Senate HELP Committee, by
letter dated July 31, 2006, Defendant von Eschenbach advised Barr-Duramed that FDA would
approve OTC distribution for women aged 18 and older and that no rulemaking was necessary to
resolve the novel issues raised by Barr-Duramed’s SNDA for Plan B. Defendants timed the
release of the letter to coincide with Defendant von Eschenbach’s hearing. On July 31, 2006,
Senator Clinton issued a press release to indicate that “[she and Senator Murray] will maintain
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our hold on Dr. von Eschenbach’s nomination until a decision is made.” In addition, prior to July
31, 2006, Senator Clinton advised Defendants von Eschenbach and FDA that she would not lift
her hold on Defendant von Eschenbach until they approved Plan B for OTC distribution.
80. At his confirmation hearing before the Senate HELP Committee, Defendant von
Eschenbach offered testimony that “[i]n the 11 months since President Bush appointed me as
Acting Commissioner, I have become acutely aware of the Agency’s need for strong and
permanent leadership with a Commissioner that is not only the choice of the President but also
confirmed by the United States Senate.” He also indicated that the timing of his letter dated July
31, 2006 (i.e., the day before his hearing), resulted from the timing of the legal process unfolding
within FDA (e.g., Defendants’ deciding that the information submitted in response to the
ANPRM indicated FDA did not need to undertake a rulemaking to approve a dual Rx-OTC Plan
B product and deciding that Barr-Duramed’s risk management plan would ensure that the girls
for whom Defendants found Plan B unsafe would receive the necessary medical supervision).
Defendant von Eschenbach’s oral and written testimony is available at from the Committee on
Health, Education, Labor, and Pensions of the U.S. Senate’s internet page on the
nomination hearing of then-Acting Commissioner von Eschenbach on August 1, 2006,
http://help.senate.gov/Hearings/2006_08_01/2006_08_01.html (last visited Mar. 18, 2008).
Assuming arguendo that the timing of Defendant von Eschenbach’s letter was unrelated to the
timing of his hearing the next day, the nexus between the two events has the appearance that the
two events were related in their timing, with the letter calculated to secure a release of the
Senators’ holds.
81. By memorandum dated August 23, 2006, Defendant von Eschenbach concluded
that (while Plan B was not safe or efficacious for OTC distribution to girls aged 16 and under)
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enforcement issues and Barr-Duramed’s voluntary “CARE” program to limit distribution
warranted FDA’s limiting OTC approval to women aged 18 and older to protect the public health
by minimizing the likelihood of younger girls’ having access to Plan B without professional
supervision. By memorandum dated August 24, 2006, Dr. Galson concurred with Dr. von
Eschenbach. Dr. Galson’s memorandum expands FDA’s meaningful-difference policy to include
a sixth factor (namely, the age of the drug’s consumer).
82. By press release dated August 24, 2006, Senators Clinton and Murray released
their holds on the Senate HELP Committee’s consideration of Defendant von Eschenbach’s
confirmation as FDA Commissioner. The Defendants’ correspondence with Senators Clinton and
Murray (as well as those acting on the Senators’ behalf) and the Defendants’ analysis of and
deliberations over the Senators’ holds constitute part of the administrative record for the
challenged agency actions and inaction.
83. By letter dated August 26, 2006, Dr. Galson made an approvable finding for Plan
B for OTC distribution to women aged 18 and older, while retaining Rx distribution for girls
under 18. In the approvable letter, FDA conditioned its approval on Barr-Duramed’s Convenient
Access Responsible Education (“CARE”) program and dual Rx-OTC labeling to require keeping
Plan B “behind the counter” and distributed only by pharmacies. Because Dr. Galson viewed the
approval to change the prior NDA only for women aged 18 and older, the approval letter
indicates that PREA does not apply.
84. As approved for Plan B’s dual OTC-Rx distribution, the Plan B labeling contains
the legend “Rx only for age 17 and younger” and directions for use that purport to comply with
both FDA’s OTC-labeling and Rx-labeling requirements.
85. On September 27, 2006, the Senate HELP Committee approved Defendant von
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Eschenbach’s nomination as FDA Commissioner and reported it to the full Senate. On December
7, 2006, the full Senate confirmed Defendant von Eschenbach as FDA Commissioner. Consistent
with information that they received publicly and privately from Senators Clinton and Murray,
Defendants believed that without their actions on Plan B, the Senate HELP Committee would not
have voted Defendant von Eschenbach’s confirmation out of Committee to the full Senate.
86. On October 2, 2006, in a meeting with Plaintiffs CWA and FRC to seek support
for his confirmation by the full Senate, Defendant von Eschenbach and FDA staff confirmed that
Dr. Galson’s memorandum dated August 24, 2006, added age as a new criterion to FDA’s
meaningful-difference test. At that meeting, FDA’s General Counsel, Sheldon Bradshaw, argued
for the FDA attendees that – because the prior criteria were not created by statute or notice-and-
comment rulemaking – FDA could add age as a new criterion without notice-and-comment
rulemaking.
Plan B’s Safety and Efficacy for Adults
87. As explained in Paragraph 50, the FFDCA and the Durham-Humphrey
Amendments require consideration of more than mere toxicity in the assessment of a drug’s
“safety” for OTC distribution. In states where only a physician may issue a prescription for an
Rx drug, Plan B’s OTC availability will cause women to obtain non-prescription Plan B without
the doctor visit previously required. As indicated in Paragraph 18, these women therefore will
forego (a) direct medical advice about drug interactions, including those drugs indicated on Plan
B’s labeling, (b) medical screening for medical contraindications for the known and expected
risks of oral contraceptives, (c) physician counseling about the various health risks associated
with sexual activity, and (d) medical screening (e.g., pap smear; breast-cancer screening;
mammograms for women over 40; sexually transmitted diseases; cervical cancer; human
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papilloma virus prevention; cholesterol, blood pressure, and other cardiovascular screening).
88. OTC availability of Plan B causes an increase in the incidence of sexually
transmitted diseases. In response to Defendants’ ANPRM, Plaintiffs submitted comments to
FDA that provided Defendants notice that OTC availability of Plan B will cause an increase in
the incidence of sexually transmitted diseases. Defendants’ approval of Plan B did not consider
these impacts.
89. OTC availability of Plan B causes a decrease in the medical visits, counseling,
and screening of women. In response to Defendants’ ANPRM, Plaintiffs submitted comments to
FDA that provided Defendants notice that OTC availability of Plan B will cause a decrease in
the medical visits, counseling, and screening of women. Plaintiffs’ comments cited peer-
reviewed literature for the proposition that emergency-contraceptive users are significantly more
likely than controls never to have had a pelvic examination (26% vs. 6%, P<0.002) or a pap
smear (24% vs. 6%, P<0.002). Defendants’ approval of Plan B did not consider these impacts.
90. The Plan B labeling falsely and misleadingly claims that Plan B “reduces the risk
of pregnancy by at least 75%” for “[t]reatment initiated within 72 hours of unprotected
intercourse.” The data available at the time that Defendants acted on the Plan B SNDA suggest
that 75% substantially overstates Plan B’s actual efficacy.
91. The Plan B labeling misleadingly compares an efficacy rate of 75% (i.e., a failure
rate of 25%) for perfect use, in a single instance, versus the failure rates of traditional
contraceptives for both typical and perfect use, over an entire year. To avoid misleading the
OTC public (as well as physicians and pharmacists), Plan B’s labeling should compare the same
statistic for each method (e.g., single-instance perfect use versus single-instance perfect use) and
must present any disclaimers “with such conspicuousness (as compared with other words,
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statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read
and understood by the ordinary individual under customary conditions of purchase and use”
under 21 U.S.C. §352(c), and Plan B’s labeling fails that standard.
92. Plan B’s label warnings include “not effective in terminating an existing
pregnancy” (emphasis added) to convey its lack of efficacy to terminate an implanted embryo,
but use the lesser warnings “not recommended for routine use as a contraceptive” and “Not
Intended To Replace Regular Birth Control” (emphasis added) to describe its efficacy as a
replacement for traditional contraceptives. Given Plan B’s low efficacy versus traditional
contraceptives, that labeling is inadequate to alert consumers of Plan B’s lack of effectiveness. In
order to provide the FFDCA-required warning to consumers, Plan B’s labeling must explicitly
and prominently warn consumers that Plan B is “not effective for routine use” or words to that
effect “with such conspicuousness (as compared with other words, statements, designs, or
devices, in the labeling) and in such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use” under 21 U.S.C. §352(c),
and Plan B’s labeling fails that standard.
93. The label comprehension test submitted to support Plan B demonstrates that only
75% of respondents understood Plan B’s label to caution against taking Plan B in the presence of
unexplained vaginal bleeding, and only 67% understood its statement that Plan B is not a
replacement for regular methods of contraception. Plan B’s label comprehension test establishes
that significant groups do not understand the labeling to limit Plan B’s usage as a replacement
for traditional contraceptives.
94. As indicated, Plan B’s label fails to convey the limitations on Plan B’s safety and
efficacy as an alternative to traditional contraceptives, and from the label comprehension test
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confirms that failure for a substantial percentage of women. In addition, Defendants should have
considered the effect that Plan B’s proponents have had in misleading substantial numbers of
women. By letter dated November 19, 2002 (MACMIS ID #11214), FDA’s Division of Drug
Marketing, Advertising, and Communications issued a warning letter asking Plan B’s sponsor to
cease disseminating false and misleading advertising that overstated Plan B’s efficacy. The
mindset that created the false and misleading advertising continues to exist among Plan B
proponents and directly and indirectly continues to mislead a substantial numbers of women to
view Plan B as significantly more efficacious than it is.
95. By letter dated December 29, 2004 (MACMIS ID #12748), FDA’s Division of
Drug Marketing, Advertising, and Communications issued a warning letter asking Barr to cease
disseminating false and misleading advertising that understated the safety of another
contraceptive product that contains levonorgestrel in conjunction with ethinyl estradiol.
96. Given Plan B’s poor efficacy vis-à-vis traditional contraceptives, the use of Plan
B as a replacement for traditional contraceptives by a nontrivial segment of contraceptive users
creates more unintended pregnancies than the number of unintended pregnancies that Plan B
prevents through its intended (but improperly communicated) use.
PREA and Plan B’s Safety and Efficacy for Adolescents
97. Defendants premised their authority to approve OTC status only for women 18
and over, without requiring PREA data, on the SNDA’s changing the Plan B labeling only for
non-PREA subpopulations (i.e., “adults” aged 18 and older). Contrary to Defendants’ premise,
PREA does not include such rigid age ranges, and puberty extends beyond the eighteenth
birthday for a significant pediatric subpopulation of young women. See, e.g., Leon Speroff &
Mark A. Fritz, Clinical Gynecologic Endocrinology and Infertility, at 370 (Lippincott Williams
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& Wilkins 7th ed. 2005); FDA, “International Conference on Harmonisation; E11: Clinical
Investigation of Medicinal Products in the Pediatric Population,” 65 Fed. Reg. 19,777, 19,780
(2000); FDA, “International Conference on Harmonisation; E11: Clinical Investigation of
Medicinal Products in the Pediatric Population; Availability,” 65 Fed. Reg. 78,493 (2000); FDA,
“Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric
Population,” at 9 (Dec. 2000).
98. The data supporting Plan B fail to establish the safety of Plan B’s high doses of a
systemically absorbed hormone in females (of whatever age) undergoing puberty’s time-
sensitive and cellular-level changes. The label’s inadequacy exacerbates the lack of data
supporting safety during puberty because the label does not adequately warn against use of Plan
B as an alternative to traditional (“Plan A”) contraceptives. The failure of the labeling exposes
women and girls to multiple uses per month and regular (i.e., month to month) use, neither of
which dosages were addressed by Plan B’s safety data in either pubescent females or mature
females.
99. Under the heading “Pediatric Use,” Plan B’s labeling includes the following:
Safety and efficacy of progestin-only pills have been established in
women of reproductive age for long-term contraception. Safety
and efficacy are expected to be the same for postpubertal
adolescents under the age of 16 and for users 16 years and older.
Use of Plan B® emergency contraception before menarche is not
indicated.
The foregoing labeling statement (a) expressly implies that Plan B is safe and efficacious for
adolescents over the age of puberty; (b) by negative implication, implicitly authorizes use of
Plan B after menarche; and (c) inaccurately implies that Plan B has been found safe for pubertal
adolescents aged 16 and over. Because Plaintiffs’ review of Plan B labeling on Defendants’
website and in the medical literature did not establish whether the foregoing Pediatric Use
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language appeared in Plan B’s labeling as originally approved in 1999, Plaintiffs allege in the
alternative that FDA approved the foregoing Pediatric Use language as part of the original NDA
and that FDA approved the foregoing Pediatric Use language in a subsequent SNDA.
100. FFDCA does not prohibit someone 18 or older from purchasing Plan B and giving
it to someone younger than 18. Notwithstanding the Rx-only labeling for girls under 18, that
population certainly will have widespread FFDCA-noncompliant access to Plan B, without
prescription, through older friends and siblings and others. Similarly aged children readily obtain
access to alcohol and tobacco products, notwithstanding government and merchant efforts to
restrict or even criminalize distribution of such products to minors. See, e.g., D.F. Preusser &
A.F. Williams, Sales of Alcohol to Underage Purchasers in Three New York Counties and
Washington D.C., J. OF PUB. HEALTH POLICY 13(3):306-317 (1992) (underage alcohol purchasers
in Washington succeeded in 97% of purchase attempts); A.C. Wagenaar & M. Wolfson,
Enforcement of the Legal Minimum Drinking Age in the United States, J. OF PUB. HEALTH
POLICY 15(1):37-58 (1994) (for every 100,000 occasions of underage drinking, only 5 alcohol
outlets incur actions by a state alcohol beverage control agency).
COUNT I
UNSAFE FOR OTC DISTRIBUTION
101. Plaintiff incorporates Paragraphs 1-100 and 106-142 as if fully set forth herein.
102. To qualify for OTC distribution, the manufacturer must establish the drug’s safety
and effectiveness for use by consumers without the professional supervision of a practitioner
licensed by law to administer drugs. The SNDA data submitted to support Plan B’s Rx-to-OTC
switch do not establish either Plan B’s safety or its effectiveness.
103. As confirmed by its label comprehension test results (Paragraph 93), Plan B’s
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labeling does not adequately warn consumers of Plan B’s ineffectiveness for routine
contraception. For the reasons set forth in Paragraphs 87-96 and 97-100, Plan B is neither safe
nor efficacious for OTC use.
104. For the foregoing reasons, the data submitted to support the SNDA for Plan B did
not include adequate tests by methods reasonably available to show that Plan B is safe and
effective for use under the conditions prescribed and suggested by Plan B’s labeling, the results
of the label comprehension test and safety testing do not show that Plan B is safe and effective
for use under such conditions, and FDA had inadequate data to determine that Plan B is safe and
effective under such conditions.
105. For the foregoing reasons, Defendants’ Plan B Approval Order is arbitrary,
capricious, an abuse of discretion, not otherwise in accordance with the law, in excess of
authority granted by law, ultra vires, and without observance of procedure required by law.
COUNT II
UNLAWFUL DUAL OTC/RX APPROVAL
106. Plaintiff incorporates Paragraphs 1-105 and 110-142 as if fully set forth herein.
107. FFDCA authorizes approval of a drug product for only one of two mutually
exclusive modes of distribution and labeling: OTC or Rx. FFDCA does not authorize approval of
the same drug product, with the same labeling, for simultaneous distribution as both an OTC and
an Rx product. To the contrary, FFDCA prohibits the simultaneous distribution of the same drug
product as both an Rx and OTC drug.
108. FFDCA authorizes exemption of a new drug from the prescription requirements
of 21 U.S.C. §353(b)(1) only by regulation under 21 U.S.C. §353(b)(3), and Defendants have not
issued such a regulation. To the extent that Plan B remains “[a] drug that is subject to paragraph
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(1)” for purposes of 21 U.S.C. §353(b)(4)(A) at all times, even when distributed OTC pursuant
to Defendants’ Plan B Approval Order, that distribution nonetheless is “an act [that] results in
the drug being misbranded while held for sale” within the meaning of 21 U.S.C. §353(b)(1).
109. For the foregoing reasons, Defendants’ Plan B Approval Order is arbitrary,
capricious, an abuse of discretion, not otherwise in accordance with the law, in excess of
authority granted by law, ultra vires, and without observance of procedure required by law.
COUNT III
UNLAWFUL BIFURCATION BY AGE
110. Plaintiff incorporates Paragraphs 1-109 and 119-142 as if fully set forth herein.
111. Assuming arguendo that FFDCA authorizes dual OTC-Rx distribution of the
same drug product with the same labeling (or alternatively that FFDCA authorizes dual OTC-Rx
distribution of the same drug product with different labeling), the FFDCA does not authorize the
Defendants’ approval of Plan B for simultaneous OTC distribution for women 18 and over and
Rx distribution to girls under 18. Specifically, FDA lacks the authority to enforce Plan B’s age
limitations.
112. Assuming arguendo that FFDCA authorizes approval of a drug product for
simultaneous OTC distribution to adults 18 and over and Rx distribution to girls under 18,
Defendants’ approval of Plan B for OTC distribution to women 18 and over nonetheless would
violate the FFDCA and APA because Plan B’s free availability OTC guarantees that – as with
widespread underage access to alcohol and tobacco products – underage girls will obtain
unsupervised access to Plan B, which FDA has found unsafe for such girls.
113. Defendants made four distinct legal errors in determining that PREA does not
apply to Plan B’s SNDA because the label changes concerned only non-PREA subpopulations
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(i.e., adults 18 and over). First, and most obviously, the SNDA includes changed label
indications for all women past their eighteenth birthday, which includes significant numbers of
females still within puberty and adolescence (i.e., FDA incorrectly reasoned that the eighteenth
birthday truncates all relevant pediatric subpopulations). Second, by its terms, the temporal “at
this time” limitation of the 1999 NDA’s waiver of pediatric data (Paragraph 97) did not
prospectively waive PREA for all future SNDAs for Plan B. Third, the label’s claimed indication
of safety and efficacy for “postpubertal adolescents under the age of 16 and for users 16 years
and older” (Paragraph 99) requires PREA data. Fourth, even if Defendants’ “adults-only” OTC
approval did not change the indications for PREA subpopulations, the provisions of 21 U.S.C.
§355c(a)(2)(A)(ii) are not limited to “claimed indications,” which renders Defendants’ rationale
inapposite: the 2006 SNDA requires data to support dosing and administration under
§355c(a)(2)(A)(ii) for all pediatric subpopulations, even if it does not require data to support the
safety or effectiveness under §355c(a)(2)(A)(i) for a single one of those subpopulations.
114. Because PREA applies past the eighteenth birthday for systemically absorbed
hormonal drugs like Plan B, the Plan B SNDA required not only dosage and administration data
to support all indications for all pediatric subpopulations (i.e., regardless of Rx versus OTC
distribution), but also safety and efficacy data to support the OTC indication for pediatric
subpopulations past their eighteenth birthday but still within puberty and/or adolescence. For the
foregoing reasons, the data submitted to support Plan B’s age-bifurcated Rx-to-OTC switch did
not satisfy PREA’s (and thus FFDCA’s) requirements.
115. Even under Defendants’ view of PREA, the Plan B SNDA required data on
relevant PREA subpopulations (namely, girls from menarche up to their eighteenth birthday),
based on foreseeable misuse by those subpopulations.
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40
116. For the foregoing reasons, the data submitted to support the SNDA for Plan B did
not include adequate tests by methods reasonably available to show that Plan B is safe for use
under the conditions prescribed and suggested by Plan B’s labeling, the results of the label
comprehension test and safety testing do not show that Plan B is safe for use under such
conditions, and FDA had inadequate data to determine that Plan B is safe under such conditions.
117. Under 21 U.S.C. §355c(d)(1), the failure to submit an assessment under
subsections 21 U.S.C. §355c(a)(2)(A)(i) or (a)(2)(A)(ii) renders a product such as Plan B
misbranded solely because of that failure.
118. For the foregoing reasons, Defendants’ Plan B Approval Order is arbitrary,
capricious, an abuse of discretion, not otherwise in accordance with the law, in excess of
authority granted by law, ultra vires, and without observance of procedure required by law.
COUNT IV
UNLAWFUL “THIRD CLASS” OF DRUG
119. Plaintiff incorporates Paragraphs 1-118 and 125-142 as if fully set forth herein.
120. FDA lacks the authority to go beyond FFDCA’s OTC-Rx dichotomy to create a
“third class” of drugs (i.e., a class of drugs that require pharmacists to supplement the labeling or
that certain subpopulations might misuse with direct access).
121. Such a third class of drugs creates anti-competitive and anti-consumer effects on
the distribution of nonprescription drugs. The U.S. Justice Department and the National
Association of Attorneys General oppose creating such a third class of drugs.
122. FDA lacks the authority to impose, or to authorize the imposition of, the anti-
competitive and anti-consumer impacts created by a third class of drugs generally or by Plan B’s
CARE program specifically.
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41
123. FDA lacks authority to impose, or to authorize the imposition of, controls such as
the CARE program’s prohibiting or restricting shipment of FDA-approved drugs to duly licensed
pharmacies.
124. For the foregoing reasons, Defendants’ Plan B Approval Order is arbitrary,
capricious, an abuse of discretion, not otherwise in accordance with the law, in excess of
authority granted by law, ultra vires, and without observance of procedure required by law.
COUNT V
FAILURE TO CONVENE APA RULEMAKING
125. Plaintiff incorporates Paragraphs 1-124 and 128-142 as if fully set forth herein.
126. By failing to convene a rulemaking to add its new, patient-based “age” parameter
to the its prior, drug-based, five-parameter interpretation of the meaningful-difference test, FDA
amended a rule without the required notice-and-comment rulemaking. 5 U.S.C. §553(b)-(c).
127. For the foregoing reasons, Defendants’ Plan B Approval Order is arbitrary,
capricious, an abuse of discretion, not otherwise in accordance with the law, in excess of
authority granted by law, ultra vires, and without observance of procedure required by law.
COUNT VI
FAILURE TO CONVENE FFDCA RULEMAKING
128. Plaintiff incorporates Paragraphs 1-127 and 132-142 as if fully set forth herein.
129. Under 21 C.F.R. §310.200(b) and 21 U.S.C. §353(b)(3), FDA can remove a drug
from the prescription requirements of 21 U.S.C. §353(b)(1) only by regulation. By purporting to
remove a new drug (Plan B) from FFDCA’s Rx requirements in an approved NDA without the
required rulemaking, FDA violated the Durham-Humphrey Amendments, which require FDA to
remove drugs by regulation.
130. To the extent that 21 C.F.R. §310.200(b) purports to replace the statutorily
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42
required “regulation” with a “finding” in an FDA order, 21 C.F.R. §310.200(b) exceeds FDA’s
authority under the FFDCA and APA. Agencies lack authority to exempt themselves, by rule,
from otherwise-applicable statutory rulemaking requirements.
131. For the foregoing reasons, Defendants’ Plan B Approval Order is arbitrary,
capricious, an abuse of discretion, not otherwise in accordance with the law, in excess of
authority granted by law, ultra vires, and without observance of procedure required by law.
COUNT VII
UNLAWFUL POLITICAL PRESSURE
132. Plaintiff incorporates Paragraphs 1-131 and 137-142 as if fully set forth herein.
133. The “holds” that Senators Clinton and Murray placed on the Senate HELP
Committee’s consideration of the nomination of then-Acting Commissioner von Eschenbach as
FDA Commissioner improperly influenced consideration of the Plan B SNDA and the proposed
Rx-to-OTC switch by Defendants United States and FDA institutionally, Defendant von
Eschenbach in his official capacity as Acting FDA Commissioner, and Defendant von
Eschenbach personally.
134. In the alternative, the foregoing Senate holds create the improper appearance of
improper influence over Defendants United States and FDA institutionally and Defendant von
Eschenbach, both in his official capacity as Acting FDA Commissioner and personally.
135. By linking Defendant von Eschenbach’s confirmation (which all Defendants
desired) with approval of the Plan B SNDA (which all Defendants had to decide), the “holds” by
Senators Clinton and Murray had an immediate and direct nexus with the approval of Plan B.
136. For the foregoing reasons, Defendants’ Plan B Approval Order and their decisions
to forego notice-and-comment rulemaking are arbitrary, capricious, an abuse of discretion, not
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43
otherwise in accordance with the law, in excess of authority granted by law, ultra vires, and
without observance of procedure required by law.
COUNT VIII
UNAUTHORIZED ADMINISTRATIVE EXHAUSTION
137. Plaintiff incorporates Paragraphs 1 through 136 as if fully set forth herein.
138. Nothing in FDA’s regulations requires an interested person to file an
administrative petition prior to seeking judicial review of an unlawful final agency action. To the
extent that FDA’s regulations purport to require filing an administrative petition prior to seeking
judicial review of final agency action, those regulations exceed Defendants’ authority because
(a) FDA lacks statutory authority to require exhaustion, and (b) FDA’s regulations violate 5
U.S.C. §704’s requirement that (in such cases) agency exhaustion requirements must hold the
challenged agency action inoperative during any intra-agency remedy for that agency exhaustion
requirement lawfully to forestall judicial review under the APA.
139. The purported restriction in 21 C.F.R. §10.45(e) of this Court’s power to grant
interim injunctive relief, without Plaintiffs’ first petitioning FDA and its Commissioner for an
administrative stay, violates constitutional separation of powers principles and exceeds
Defendants’ authority.
140. Defendants’ Plan B Approval Order is unlawful final agency action, which
Plaintiffs can challenge via judicial review and against which Plaintiffs can seek interim
injunctive relief in this Court, without first filing an administrative petition with Defendants.
141. For the foregoing reasons, any attempt by Defendants to impose by regulation a
mandatory administrative process that an interested person must exhaust before seeking judicial
review of, or interim injunctive relief against, unlawful final agency action without rendering
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that agency action inoperative is not otherwise in accordance with the law, in excess of authority
granted by law, and ultra vires.
PRAYER FOR RELIEF
142. WHEREFORE, Plaintiffs respectfully asks this Court to grant the following relief:
A. Pursuant to 5 U.S.C. §706, 28 U.S.C. §§1331, 2201-2202, the Acts of March 3, 1863, 12
Stat. 762, and June 25, 1936, 49 Stat. 1921 (as amended), D.C. Code §11-501, Fed. R.
Civ. Proc. 57, and this Court’s equitable powers, a Declaratory Judgment that:
(i) When the required safety studies submitted to support an OTC drug rely on lower
than expected dosages, FDA and its Commissioner cannot approve the drug for
OTC distribution unless the labeling reflects the low dosages in language
designed to alert the consumer that the drug is unsafe or not approved for use
above that dosage;
(ii) When considering the safety of an Rx drug for OTC distribution, FDA and its
Commissioner must assess (and, where relevant, require data on) the “safety” of
that switch under all potentialities for harmful effect, collateral measures needed
to use the drug safely, and the suitability of the drug for use without medical
supervision, which for contraceptives or abortifacients includes anticipated
misuse of the drug, any increase or decrease in risky or unsafe sexual activity, any
increase or decrease in the rates of unintended pregnancies and abortions, and the
health effects of foregoing medical counseling and screening;
(iii) When comparing the safety of a drug intended as a contraceptive or abortifacient,
FDA and its Commissioner must test the drug’s safety against alternate
pharmaceutical or surgical treatments to prevent or abort a pregnancy, not against
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45
pregnancy itself;
(iv) FDA and its Commissioner lack the authority to approve the same drug product
for simultaneous OTC-Rx distribution under the same labeling;
(v) Any drug product labeled for simultaneous OTC-Rx distribution is misbranded;
(vi) Any so-called “morning after pill” or “emergency contraceptive” such as Plan B
is misbranded if its labeling compares its efficacy in a single use versus the
efficacy of traditional methods of contraception over an entire year;
(vii) In approving an NDA or SNDA, FDA and its Commissioner must consider likely
misuse in making their FFDCA safety determinations;
(viii) For SNDAs filed after April 1, 1999, FDA must require applicants to submit data
pursuant to the Pediatric Research Equity Act (“PREA”) to support any misuse
likely to affect relevant PREA subpopulations, even if the SNDA’s changes in
claimed indications (or other changes) do not concern such subpopulations;
(ix) The failure to submit a PREA assessment under 21 U.S.C. §355c(a)(2)(A)(i) and
(a)(2)(A)(ii) renders Plan B misbranded solely because of that failure.
(x) FDA and its Commissioner lack the authority to create or to approve the creation
of a “third class” of behind-the-counter pharmacist-dispensed drugs;
(xi) FDA must conduct notice-and-comment rulemaking before it can consider a
patient’s age or other subpopulation criteria in determining whether to approve an
NDA or SNDA that results in an Rx-to-OTC switch for a drug product based on
labeling that restricts use by age or by such other subpopulation criteria;
(xii) Defendants violated the APA’s and FFDCA’s rulemaking requirements by
purporting to add an age parameter to the meaningful-difference test for Rx-to-
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OTC switches and by purporting to remove Plan B from Rx status by order,
without promulgating a regulation;
(xiii) Under 21 C.F.R. §310.200(b) and 21 U.S.C. §353(b)(3), FDA must conduct a
rulemaking to exempt a new drug from Rx requirements of 21 U.S.C. §353(b)(1);
(xiv) FDA and Commissioner von Eschenbach approved the OTC switch for Plan B
and decided to forego notice-and-comment rulemaking under actual and improper
congressional pressure;
(xv) In the alternative, FDA and Commissioner von Eschenbach approved the OTC
switch for Plan B and decided to forego notice-and-comment rulemaking under
the improper appearance of improper congressional pressure;
(xvi) FDA and Commissioner von Eschenbach lack the authority to impose a
mandatory administrative process that an interested person must exhaust before
challenging unlawful final agency action in court and before seeking interim
injunctive relief against such unlawful final agency action in court; and
(xvii) Federal courts, FDA, and Commissioner von Eschenbach lack the authority to
require administrative exhaustion through FDA’s citizen-petition process because
that process does not hold the FDA action inoperative during the intra-agency
proceeding.
B. Pursuant to 5 U.S.C. §706, 28 U.S.C. §§1331, 2202, the Acts of March 3, 1863, 12 Stat.
762, and June 25, 1936, 49 Stat. 1921 (as amended), D.C. Code §11-501, and this Court’s
equitable powers, an Order providing that
(i) Defendants’ Plan B Approval Order is vacated; and
(ii) Defendants are enjoined from approving Plan B for OTC distribution via SNDA
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47
or NDA unless such approval is fully consistent with the declaratory relief in
Paragraph 142(A).
C. Pursuant to 28 U.S.C. §2412 and any other applicable provisions of law or equity, award
Plaintiffs’ costs and reasonable attorneys fees.
D. Such other relief as may be just and proper.
Dated: March 18, 2008 Respectfully submitted,
/s/ Lawrence J. Joseph
Lawrence J. Joseph, D.C. Bar No. 464777
1250 Connecticut Ave, NW, Suite 200
Washington, DC 20036
Telephone: (202) 669-5135
Telecopier: (202) 318-2254
Counsel for Plaintiffs Association of American
Physicians and Surgeons, Inc., Concerned Women
for America, Family Research Council, and Safe
Drugs for Women
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Exhibit 1
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FDA Simultaneous Marketing ANPRM
Bracketed Comment Letter Report
May 19, 2006
Final
Prepared by
ICF International
Fairfax, VA
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page i
Index of Comments by Name
Academy of Managed Care Pharmacy ....................................................................................... 154
Aengst, Jennifer .......................................................................................................................... 374
Ahmed , Stephanie ...................................................................................................................... 111
Alterton, Faith ............................................................................................................................... 95
American Civil Liberties Union.................................................................................................. 402
American Pharmacists Association............................................................................................. 168
American Society for Reproductive Medicine ............................................................................... 6
Anspach, Kurt ............................................................................................................................. 269
Arnall Golden Gregory LLP ......................................................................................................... 12
Association of American Physicians & Surgeons ...................................................................... 157
Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc. ......................................................... 70
Babalola, Abimbola .................................................................................................................... 398
Babb, Beverly ............................................................................................................................. 185
Bachelor, Emiliann ..................................................................................................................... 163
Baird, Debora.............................................................................................................................. 322
Billingsley, Daniel ...................................................................................................................... 309
Bilz, Michael............................................................................................................................... 258
Black, Jerrold .............................................................................................................................. 110
Blume, John ................................................................................................................................ 178
Brakman, Anita ........................................................................................................................... 385
Brass, Kathryn............................................................................................................................. 380
Burgess, Annette ......................................................................................................................... 298
Burns, Ben................................................................................................................................... 375
Burometto Jr, Charles ................................................................................................................. 107
Cahoon, Clifton........................................................................................................................... 348
Camron, Kiera............................................................................................................................. 353
Card, Alan ................................................................................................................................... 311
Carlson, Brent ............................................................................................................................. 342
Carter, Thomas............................................................................................................................ 331
Cepeda, Baudi ............................................................................................................................. 223
Chihane, Ziad.............................................................................................................................. 128
Clague, Alexander....................................................................................................................... 125
Clason, Dennis ............................................................................................................................ 276
Collum, Mark.............................................................................................................................. 247
Connors, Meaghan ...................................................................................................................... 138
Consumer Healthcare Products Association................................................................................. 20
Corder, Traci ............................................................................................................................... 368
Corlette, Chauncey...................................................................................................................... 142
Crousey, Joshua .......................................................................................................................... 199
Cunningham, Laura..................................................................................................................... 280
Cunningham, Wayne................................................................................................................... 229
Dalton, Mike ............................................................................................................................... 390
Dawson, Jennifer......................................................................................................................... 333
Della Paolera, Mark .................................................................................................................... 295
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Deneris, Angela........................................................................................................................... 253
Devine, Naomi ............................................................................................................................ 334
DeWitte, Conrad ......................................................................................................................... 316
Dietz, Ken ................................................................................................................................... 219
Dolinski, Elizabeth...................................................................................................................... 287
Doran, Gregory ........................................................................................................................... 305
Dorn, Kellie................................................................................................................................. 119
Dougherty, Anne......................................................................................................................... 124
Dowell, Duane ............................................................................................................................ 196
Duchon, Kathleen ....................................................................................................................... 266
Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. ...................................................... 53
Ellis, Pamela ............................................................................................................................... 218
Endris, Kelle ............................................................................................................................... 232
Etter, Eleanor .............................................................................................................................. 383
Family Planning Advocates of New York State ........................................................................... 90
Farren, Wanda............................................................................................................................. 117
Felty, Amy .................................................................................................................................. 209
Fisher, Julie ................................................................................................................................. 251
Fogelgren, Katharine................................................................................................................... 355
Friedl, Mary Frances................................................................................................................... 325
Garden, Nicole ............................................................................................................................ 144
Gay, Sarah................................................................................................................................... 200
Gibbons, Bridget ......................................................................................................................... 202
GlaxoSmithKline ............................................................................................................................ 1
Goggin, Terresa........................................................................................................................... 216
Goodman, Evan........................................................................................................................... 307
Gordon, Jennifer ......................................................................................................................... 326
Gorini, Joseph ............................................................................................................................. 336
Guy, Katie ................................................................................................................................... 367
Hagan, Jane ................................................................................................................................. 241
Hager, Joseph R .......................................................................................................................... 335
Hawkins, Susan........................................................................................................................... 372
Hein, Rachel................................................................................................................................ 184
Hibberd, Rachel .......................................................................................................................... 197
Holden, Karen ............................................................................................................................. 366
Hudson, Ralph............................................................................................................................. 249
Hutson, Paul................................................................................................................................ 164
Jago, Laura.................................................................................................................................. 358
Jones, Kim................................................................................................................................... 166
Katrib, Elise ................................................................................................................................ 282
Keys, Lori ................................................................................................................................... 387
Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.27
Kisly, Anne ................................................................................................................................. 213
Koch, Frances ............................................................................................................................. 313
Kopp, Margaret ........................................................................................................................... 370
Kortebein, Peter .......................................................................................................................... 320
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Kowalczyk, Brigid ...................................................................................................................... 284
Kulshrestha, Vikram V ............................................................................................................... 260
Kuskey, Garvan........................................................................................................................... 347
Kwak, Eugene ............................................................................................................................. 133
Labbe, Carl.................................................................................................................................. 261
LaChance, Robin........................................................................................................................... 89
Ladd, Judy..................................................................................................................................... 96
Lamermayer, Richard J............................................................................................................... 268
Lamotte, Diane............................................................................................................................ 151
Landauer, Christopher................................................................................................................. 277
Leonard, Ruth Tehila .................................................................................................................. 306
Levinson, R. Saul........................................................................................................................ 235
Levy, Gayle................................................................................................................................. 206
Llewellyn, Heather...................................................................................................................... 246
Long, Laura Jean......................................................................................................................... 341
Loomis, Shirley........................................................................................................................... 147
Macdonell, Megan ...................................................................................................................... 344
Marcelli, Christian ...................................................................................................................... 165
Marshall, Laura ........................................................................................................................... 150
McCormick, Michelle ................................................................................................................. 106
McGhee, Tim .............................................................................................................................. 290
McLeod, Doug ............................................................................................................................ 252
Mershon, Claire-Helene.............................................................................................................. 123
Micro ICU Project......................................................................................................................... 74
Mock, Suzanne............................................................................................................................ 378
Moon, Kristin.............................................................................................................................. 193
Morrisroe, Julia ........................................................................................................................... 195
Munro, Margaret ......................................................................................................................... 205
Murphy, Cynthia ......................................................................................................................... 189
Myers, Micah .............................................................................................................................. 240
National Association of Boards of Pharmacy............................................................................... 68
National Research Center for Women ........................................................................................ 224
Naughton, John ........................................................................................................................... 301
Nguyen, Marie ............................................................................................................................ 137
Oberst, Sara................................................................................................................................. 362
O'Hagan, James........................................................................................................................... 356
Owens, B..................................................................................................................................... 139
Oyen, Duane ............................................................................................................................... 210
Oyola, Sandra.............................................................................................................................. 360
Padden, Phillip ............................................................................................................................ 281
Parks, C....................................................................................................................................... 224
Paslawsky, JoAnn ....................................................................................................................... 115
Pechacek, Deborah...................................................................................................................... 230
Peer, Gerald................................................................................................................................. 318
Peters, Jeanette............................................................................................................................ 129
Pfizer, Inc...................................................................................................................................... 16
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Phlips, Thomas............................................................................................................................ 345
Pinkerton, Mike........................................................................................................................... 186
Porter, Rebecca ........................................................................................................................... 297
Pruis, Trisha ................................................................................................................................ 100
Rahl, Michael.............................................................................................................................. 134
Ramirez, Robert .......................................................................................................................... 289
Rankis, A..................................................................................................................................... 220
Ray, Amy .................................................................................................................................... 319
Rectenwald, Theodore ................................................................................................................ 292
Reusch, Elizabeth........................................................................................................................ 165
Reynolds, Charles ....................................................................................................................... 120
Ricci, Stephen ............................................................................................................................. 338
Richman, Bobbi .......................................................................................................................... 208
Roettcher, Phil............................................................................................................................. 221
Rommel, Scott............................................................................................................................. 294
Rosati, Lucia ............................................................................................................................... 339
Rose, Demian................................................................................................................................ 96
Ross, Angela ............................................................................................................................... 187
Roye, Carol ................................................................................................................................. 109
Ruckdeschel, Diana....................................................................................................................... 93
Rucker, Gwendolyn .................................................................................................................... 104
Rupp, Charles.............................................................................................................................. 242
Saling, Elle.................................................................................................................................. 168
Salvo, Aaron ............................................................................................................................... 228
Scarpace, Sarah ........................................................................................................................... 255
Schmierer, Ann ........................................................................................................................... 350
Schulman, Marvin....................................................................................................................... 265
Schulz, Stan................................................................................................................................. 329
Scott, Cindy................................................................................................................................. 149
Severance, Peter.......................................................................................................................... 131
Shaffer, Kathleen ........................................................................................................................ 101
Slee, April ................................................................................................................................... 121
Smart, Stephanie ......................................................................................................................... 161
Smith, Jennifer ............................................................................................................................ 159
Smith, Rodney............................................................................................................................. 357
Socha, Kathleen .......................................................................................................................... 328
Soriano, Lauren........................................................................................................................... 141
Speight, Thomas ........................................................................................................................... 98
Steele, Robert.............................................................................................................................. 145
Steward, Linda ............................................................................................................................ 190
Stier, Christopher ........................................................................................................................ 279
Stockton, Melissa........................................................................................................................ 388
Subcommittee on Criminal Justice, Drug Policy........................................................................ 179
Syed, Misbah............................................................................................................................... 392
Tadeo, Peter ................................................................................................................................ 394
Tansley, Kathleen ....................................................................................................................... 300
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Temple, Jennie ............................................................................................................................ 390
Thames, Samuel.......................................................................................................................... 396
Thomas, Tiffany.......................................................................................................................... 126
Thompson, Donald...................................................................................................................... 263
Thompson, Sharon ...................................................................................................................... 289
TomHon, Catherine..................................................................................................................... 233
Townsend, Elisha........................................................................................................................ 369
Trubow, Marshall........................................................................................................................ 379
Tuchinsky, Marla ........................................................................................................................ 204
Tufts, Gillian ............................................................................................................................... 256
University of California, San Franscisco ........................................................................................ 4
Vander Bleek, Luke .................................................................................................................... 363
Vander Bleek, Peter .................................................................................................................... 364
Venturella, Vincent ..................................................................................................................... 304
Vrankar, Anna............................................................................................................................. 323
Vu, Tram..................................................................................................................................... 400
Wagner, Patricia.......................................................................................................................... 354
Walsh, Melissa............................................................................................................................ 160
Waychoff, W. Aaron................................................................................................................... 238
White, Alan ................................................................................................................................. 113
White, Molly ............................................................................................................................... 102
Wilson, Rhianna.......................................................................................................................... 192
Witherwax, Carol........................................................................................................................ 194
Women's Bar Associaion of the State of New York..................................................................... 73
Wu, Jackie................................................................................................................................... 236
Wurtz, Richard............................................................................................................................ 376
Yao, Yvonne ............................................................................................................................... 153
Young, Stan................................................................................................................................. 211
Zahn, Steven ............................................................................................................................... 286
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COMMENT NUMBER - 2005N-0345-C307
2005N-0345-C307 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: GlaxoSmithKline
2005N-0345-C307 - TEXT
GlaxoSmithKline
1500 Littleton Road
Parsippany, NJ
07054-3884
Tel.9738892100
Fax 973 8892390
www.gsk.com
October 28, 2005
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville
MD 20852
Re: Docket No. 2005N-0345
RIN 0910-AF72
Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in
Both a Prescription Drug Product and an Over-the-Counter Drug Product: Advance Notice of Proposed
Rulemaking, 70 Federal Register 52050 (September 1, 2005).
Dear Madam or Sir:
In the September, 2005 Federal Register the U.S. Food and Drug Administration ("FDA") published and
invited comments on the above proposed rulemaking. Specifically, the FDA request comment on,
"whether to initiate a rulemaking to codify its interpretation of section 503(b) . . ." and whether it is
necessary to, "explicitly set forth regulations that discuss the processes by which FDA classifies (or re-
classifies) drugs as OTC or prescription."
GlaxoSmithKline Consumer Healthcare (GSK CH) has extensive experience of the OTC market place,
regulations and re-classification applications, or "Rx-to-OTC switch" submissions. Such applications
have been wide ranging in therapeutic category, in U.S. and international markets and both successful,
and unsuccessful, in gaining approval for OTC status. This experience is valuable in commenting on the
Rx-to-OTC switch process and specifically the FDA proposal to promulgate further associated
regulations.
The Agency requests comments to three questions, each in two to three parts. The comments of GSK CH
follow a restatement (in italics) of each question below.
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 2
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously marketed in both a prescription drug product and an
OTC drug product?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
C. If so, would a rulemaking on this issue help dispel that confusion?
<1: 3.2>In response to questions A and B, GSK CH does not believe that FDA should initiate rulemaking
to codify its interpretation of section 503 (b). <2: 3.8.7, 4.2, 5.4.3>We see no need, or benefit, of
further regulation. Our FDA submission experience leads GSK CH to conclude that there is no confusion
regarding FDA's interpretation of section 503(b). To the contrary, we have found FDA's interpretation
very clear. It is our opinion that part C of this question is therefore moot.
<3: 3.8.4>Quite simply, if the FDA determines that the data and labeling submitted fulfill the requirement
of exemption from section 503(b), then the product is a non-prescription (i.e. OTC) drug. Conversely, if
the FDA determines that the data and labeling do not fulfill exemption from section 503(b), then the
product is a prescription drug.
<4: 3.8.4>In addition to 21 CRF 310.200 (Prescription-exemption procedure), the Agency's position on
switch products and the associated switch process is made clear by correspondence with a Sponsor and/or
as matter of general public record. This occurs via Citizens Petition, NDA action packages, the Advisory
Committee process, presentations by CDER Management and staff at public meetings and Part 15 Public
Hearings (e.g. June 28, 2000).
<5: 3.9.1>There are many good examples of why active ingredients should be available both as
prescription and OTC drugs. These include, for example, oral ibuprofen, H2 antagonists: (cimetidine,
ranitidine, famotidine, nizatadine), omeprazole, and topical miconazole and hydrocortisone. For these
products FDA have evaluated the data and determined that for some elements of the drug, section 503(b)
exemption does not apply, e.g. for reason of indication or dose. Those elements have remained
prescription status.
Other actives have switched totally, leaving no prescription status product (e.g. oral & transdermal
nicotine replacement therapies (NRT), loratidine). These products were considered section 503(b) exempt
in their totality.
<6: 3.8.4>GSK CH contends that the requirements for exemption from 503(b) regarding OTC suitability
are clear. Sponsors should continuously evaluate the healthcare environment for opportunities that benefit
both Rx and OTC users. Further regulations would be neither necessary nor helpful and may hinder
innovation.
2.
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g. by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law.
B. If it could would it be able to do so as a practical matter and if so, how?
<7: 6.4.1, 7.3.1.1, 7.3.1.2, 7.4.3>The nature of OTC availability is broad access. Although practical
restrictions on such access are limited, the Sponsor and FDA assess product safety and use in that context.
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Certain restrictions and limitations may be agreed as a condition of approval. Oral OTC nicotine
replacement products are an example. In this total switch, the OTC product was approved for the same
age range as the prescription product: (18 years and above). It was a pre-approval requirement to
demonstrate that the age limitation was understood at both a label and practical level. Additionally, sales
restrictions (no vending machine sale), defined marketing plans that included vendor systems and training
to encourage age verification, and a post approval monitoring program were conditions of approval (the
intent being to restrict off label use by those under 18 years of age). It was the Sponsor's responsibility to
comply with the restrictions as well as monitor and report on their effectiveness. Monitoring included a
program of retailer re-training to correct deficiencies and help ensure ongoing compliance. If the
sponsor's efforts proved unsuccessful, a practical, regulatory consequence was withdrawal of NDA
approval.
<8: 6.1, 6.3.1, 7.1>Thus, this is a situation where FDA, in their capacity as:
". . . experts qualified by scientific training and experience to evaluate the safety and effectiveness of
drugs, . . . for use under the conditions prescribed, recommended, or suggested in the labeling.. ."
(FFDCA, section 201(p)),
have the authority to determine the approvability of a drug product as described by a Sponsor. As a
practical matter, in our experience, it is enforceable.
3.
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
B. If the two products may be legally sold in a single package, under what circumstances would it be
inappropriate to do so?
<9: 8.3.1>In order for a product to be sold Rx or OTC it is necessary that the labeling requirements of
each legal classification be fulfilled.
In much the same way as an OTC drug product may be marketed simultaneously in a single pack as a
dietary supplement, provided the label requirements are fulfilled and comprehended, we see nothing in
principle to preclude a common pack for Rx and OTC.
However, the regulations describe very different label requirements for Rx and OTC drug products.
Therefore we see no way to a "same package" without some modified language. For example, Rx
products require a prescription legend on labeling and the inclusion of very detailed prescribing
information. The OTC label has uniform format and content requirements so as to be understood by the
consumer.
It is our opinion however, as a practical matter, that these differences might be addressed and satisfied
within the remit of the FDA, per section 201(p) of the act. Methods could include additional Rx labeling
adhered to/accompanying the OTC pack at point of dispensing and specific Rx healthcare professional
labeling. The product and labeling approaches would be approved under an OTC- and an Rx NDA.
<10: 9.1.1>Finally, in response to the last posed question, the only circumstance in which it would be
inappropriate to sell a product Rx and OTC in the same package, is when the FDA determines that the
data do not support both the Rx and OTC requirements of section 503(b).
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Thank you for your consideration of these comments
Respectfully submitted,
Sue James
Vice President Regulatory Affairs, Compliance and Quality,
GlaxoSmithKline Consumer Healthcare R&D
COMMENT NUMBER - 2005N-0345-C320
2005N-0345-C320 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: University of California, San Franscisco
2005N-0345-C320 - TEXT
University of California
San Francisco
Center for Reproductive Health
Research & Policy
October 26, 2005
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: Docket Number 2005N-0345
Dear Acting Commissioner von Eschenbach:
As clinicians and researchers at The Bixby Center for Reproductive Health Research & Policy at the
University of California, San Francisco (UCSF), we are writing to you in response to the Advance Notice
for Proposed Rulemaking in docket number 2005N- 0345.
<1: 1.2.1, 3.2, 3.8.8>The Food and Drug Administration (FDA) has the authority to switch a prescription
drug to over-the-counter (OTC) status if the drug is both safe and effective when self- administered;
potential users can self-diagnose the condition for which the drug is needed; and, the drug's label provides
clear instructions for use. Though Plan B meets all of the criteria for OTC status, the FDA has failed to
remove its prescription requirement and instead has launched down a path of bureaucratic indecision that
does not serve U.S. women. The FDA has no scientific basis for discriminating the safety of Plan B
among women of reproductive age. We strongly urge the FDA to abandon the proposed rulemaking
process and approve the original application to switch Plan B to an OTC product without restrictions.
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<2: 2.1>In a December 16, 2003 joint meeting, the Nonprescription Drugs Advisory Committee and the
Reproductive Health Drugs Advisory Committee charged with reviewing the scientific evidence on the
merits of Plan B recommended that it be approved for OTC status. However, in February 2004, Dr.
Steven Galson, Acting Director of the FDA, issued a non-approval letter citing concerns that Plan B could
not be used safely by young adolescent women. In response, Barr Corporation submitted an amendment,
proposing to change the indication to allow for marketing of Plan B as a prescription- only product for
women younger than 16 years of age and a nonprescription product for women 16 years and older. In
August 2005, the FDA announced that it was unable at this time to reach a decision on the approvability
of the application because of unresolved regulatory and policy issues that relate to the application's
discrimination to access among women of different ages.
<3: 10>Teens are a vulnerable population that face a host of barriers accessing family planning services
and therefore stand to gain most from increased access to all methods of contraception. There is no
scientifically valid reason to restrict teens' access to emergency contraception (EC), and the application
under review that proposes to have Plan B remain a prescription-only product for teens will only further
contribute to the high rates of teen pregnancy in the U.S. A substantial body of scientific evidence
demonstrates that EC offers a safe and effective back-up method of birth control; that teens can use EC
safely and correctly without medical supervision; and, that EC does not adversely affect teens' sexual
behavior.
The Bixby Center for Reproductive Health Research & Policy at UCSF has conducted research on the
safety profile of EC in young adolescents as well as studies that demonstrate that increased availability of
EC does not endanger women by affecting sexual risk-taking (see attached studies).1-4 These studies,
which were provided to the Nonprescription Drugs Advisory Committee and the Reproductive Health
Drugs Advisory Committee (either as peer-reviewed manuscripts or as pre-published data with full
documentation), are consistent with other national and international data and provide clear evidence that
teens with increased access to EC:
Are more likely to use it when needed
Are more likely to take it sooner after unprotected sex has occurred
Do not exhibit significant repeat or excessive use of EC
Do not engage in higher levels of unprotected sex
Do not abandon their routine method of contraception or use it less consistently
Do not switch to a less effective method of contraception
Do not have greater numbers of sexual partners
Do not have higher levels of sexually transmitted infections
Do not become more vulnerable to unwanted sexual activity
<4: 1.2.1>Making Plan B available to teens is imperative given the unacceptably high rates of teen
pregnancy in the U.S. Of the 800,000 teen pregnancies in this country each year, nearly 80 percent are
unintended, and one-third end in abortion. Not surprisingly, the U.S. lags behind the rest of the developed
world in making EC available to women without a prescription and has a teen birth rate that is higher than
any other developed country, including Canada (two times higher), Germany (four times higher), France
(five times higher), and Japan (nearly nine times higher). The FDA should dispense with the bureaucratic
entanglements of a "restricted" Plan B OTC access application. The failure to make a drug as safe and
effective as EC available to all women OTC places an unnecessary barrier in the way of women seeking
to prevent unintended pregnancy. Given the demonstrated safety and efficacy of EC as on OTC product
around the world, removing the prescription requirement offers a viable way to improve access and help
reduce the unacceptably high rate of unintended pregnancy in the U.S. We strongly urge the FDA to
move decisively and swiftly to switch Plan B to OTC status for women of all reproductive ages.
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 6
Signed,
Philip Darney, MD, MSc
Professor and Chief
Felicia Steward, MD
Adjunct Professor, Emeritus
Claire Brindis, DrPH, MPH
Professor
J. Joseph Speidel, MD, MPH
Adjunct Professor
Tina Raine-Bennett, MD, MPH
Associate Clinical Professor
Cynthia Harper, PhD
Assistant Professor
Enclosures:
<5: 10>1. Raine TR, Harper C, Leon K, Damey PD. Emergency contraception: Advance provision in a
young, high-risk clinic population. Obstetrics and Gynecology 2000;96: l-7.
2. Harper C, Rocca CH, Darney PD, Von Hertzen H, Raine TR. Tolerability of levonorgestrel emergency
contraception in adolescents. Contraception 2004; 191: 1158- 63.
3. Raine T, Harper C, Rocca C, Fischer R, Padian N, Klausner J, Damey, P. Direct access to
emergency contraception through pharmacies and effect on unintended pregnancy and STIs: A
randomized controlled trial. JAMA 2005;293:54-62.
4. Harper C, Cheong M, Rocca RH, Damey PD, Raine TR. The effect of increased access to emergency
contraception among young adolescents. Obstetrics and Gynecology 2005;106:483-91.
COMMENT NUMBER - 2005N-0345-C350
2005N-0345-C350 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: American Society for Reproductive Medicine
2005N-0345-C350 - TEXT
AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE
Formerly The American Fertility Society
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November 1, 2005
BY ELECTRONIC MAIL
Division of Dockets Management
United States Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
Re: Docket No. 2005N-0345 - Drug Approvals: Circumstances In Which An Active Ingredient May Be
Simultaneously Marketed In Both A Prescription Drug Product And An Over-The-Counter Drug Product
Dear Madam:
On September 1, 2005, the Food and Drug Administration ("FDA") issued an Advanced Notice of
Proposed Rulemaking ("ANPR") in connection with its recent decision to delay approval of Barr
Laboratories' emergency contraception ("EC") product, Plan B (levonorgestrel), for over-the-counter
("OTC") use in women sixteen and older. Several days earlier, FDA had announced that it was unable to
reach a decision on Barr's proposal, contained in a supplemental New Drug Application ("sNDA"), to
"switch" the drug from prescription-only to OTC because of the "novel regulatory issues" posed by the
simultaneous marketing of a product for prescription and OTC use. See FDA Statement, FDA Takes
Action on Plan B: Statement by FDA Commissioner Lester M. Crawford (Aug. 26, 2005) at
www.fda.gov/bbs/topics/news/2005/NEW01223.html.
The American Society for Reproductive Medicine ("ASRM") would like to take this opportunity to
comment on the issues raised in the ANPR. <1: 3.5.2>Specifically, the regulatory framework governing
drug approvals and prescription-to-OTC "switches" are clear and should lead to swift approval of Barr's
sNDA. <2: 3.3.3, 6.4.1>The Federal Food, Drug, and Cosmetic Act ("FDCA") establishes a
standard for classifying a drug as prescription-only that allows the agency to impose age requirements on
prescription use. Moreover, FDA has ample legal authority to enforce such a restriction and has done so
with respect to at least one other product, an "adults only" Nicorette (nicotine polacrilex) gum. <3: 1.2.2, 2.1>Consequently, FDA should stop this unreasonable delay and grant approval of OTC
levonorgestrel.
I. BACKGROUND
Plan B was approved on July 28, 1999, under a new drug application ("NDA") submitted by the Women's
Capital Corporation and subsequently purchased by Barr. The NDA referenced clinical data on nearly
15,700 women who had used levonorgestrel for EC from a study conducted by investigators working
under the sponsorship of the-world Health Organization and World Bank Special Programme of
Research, Development and Research Training in Human Reproduction. See NDA No. 21,045, FDA
Medical Officer Review, Levonorgestrel 0.75mg for Emergency Contraception (June 23, 1999).
In February 2001, ASRM joined over sixty organizations in filing a citizen petition seeking a switch from
prescription to OTC status for Preven Emergency Contraceptive Kit (ethinyl estradiol; levonorgestrel) and
Plan B. See Docket No. 2001P-0075. On several occasions since then, ASRM has communicated its view
concerning the safety and effectiveness of Plan B to President Bush, then-Commissioner Mark
McClellan, Secretary of HHS Tommy Thompson, and FDA's Reproductive Health Drugs Advisory Panel.
[Footnote 1: ASRM submitted comments to Docket No. 2001P-0075 on July 29, 2005 and December 8,
2003. ] Briefly, ASRM has stated that:
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EC is difficult to obtain during the weekend, and emergency rooms do not always provide EC. Access to
EC is crucial if it is to work effectively.
To optimize women's health, impediments to obtaining EC should be removed; OTC availability of EC
would result in increased use which could prevent 1.7 million unplanned pregnancies per year and
countless abortions.
Five states have already made it available directly from pharmacists without prescription.
Studies show the drug is safe and that consumers are easily able to follow package instructions.
Use of EC will not influence consumers to use regular contraception less frequently; if EC is available
OTC, they are more likely to use it when necessary.
On April 16, 2003, Women's Capital Corporation filed a prescription-to-OTC switch application with
FDA. See www.barrlabs.com. In December 2003, FDA convened a Joint Meeting of the Nonprescription
Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs (the "Joint
Committee") to consider the proposed switch. The Joint Committee voted 23-4 that Plan B should be
switched to OTC status.
At least one senior FDA official reviewed data contained in the Barr sNDA and concluded that it is
adequate to support approval. On April 22, 2004, Director of New Drugs Dr. John K. Jenkins wrote a
memo to the NDA concluding that, "[i]n my opinion, these studies provide adequate evidence that women
of childbearing potential can use Plan B safely, effectively, and appropriately for emergency
contraception in the non-prescription setting." See Memorandum from John K. Jenkins, MD, Director,
Office of New Drugs, FDA to NDA 21-045 (Apr. 22, 2004).
Nevertheless, several days later, FDA notified Barr that its supplemental application for OTC status was
not approvable because Barr had not provided adequate data to demonstrate that Plan B can be used
safely by young adolescent women without the professional supervision of a practitioner licensed by law
to administer the drug. See Letter to Barr from Steven Galson (May 6, 2004) (available at
http://www.barrlabs.com/pages/nprpr.html). FDA commented that only 29 of the 585 subjects enrolled in
the study were 14-16 years of age, and none was under 14 years of age. FDA noted concerns from some
members of the Joint Committee that actual use data did not reflect the overall population of non-
prescription users, particularly given the small sample of younger age groups.
In July 2004, Barr submitted a revised sNDA seeking approval of OTC Plan B for women 16 years of age
and higher. On August 26, 2005, FDA issued a letter to Barr stating that the agency was unable to make a
determination on the approvability of the sNDA, and, on September 1, issued the ANPR, which sets out
several legal issues for comment. [Footnote 2: According to Barr, the letter states that FDA "has
completed its review of this application, as amended, and has concluded that the available scientific data
are sufficient to support the safe use of Plan B as an OTC product for women who are 17 years of age and
older." See www.barrlabs.com.] <4: 2.1>ASRM is deeply disappointed by the agency's repeated delay in
approving Plan B for over-the-counter use, and submits these comments in response to the agency's
request.
II. DISCUSSION
<5: 3.3.2, 3.6.2, 6.3.2>A. FDA's Legal Authority is Clear and Supports Approval
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No statutory provision prevents FDA from imposing an age limitation on the prescription drug status of a
new drug. As a fundamental matter, the FDCA presumes that a new drug may be available OTC unless it
falls within the definition of a prescription drug in Section 503(b) of the Act. 21 USC 353(b). See, e.g., 21
CFR 330.10(a)(4)(vi); see also Leg. Hist. of Durham-Humphrey Act at S. Rep. No. 946, at 1951
USCCAN 2454, 2461. Section 503(b) provides that FDA shall impose a prescription-only restriction
where a new drug
because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral
measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by
law to administer such drug.
Thus, the statute allows FDA to determine, based either on the data contained in the sNDA or the lack of
necessary data, that Plan B poses a "potential for harmful effect" if used in women under age 16. FDA
could also find that "collateral measures" are necessary for its safe use by women under age 16 - namely
that distribution be limited to circumstances where a licensed practitioner is available to supervise its use.
[Footnote 3: Indeed, the statute is silent with respect to whether age is a relevant factor when interpreting
and applying section 503(b). Thus, under settled legal principles, the agency may "fill the gaps" in the
statute through reasonable interpretation. See US. v Mead Corp., 533 U.S. 218,234 (2001); Chevron,
USA., Inc v Natural Resources Defense Council, Inc , 467 U.S. 837 (1984).]
<6: 3.5.2>FDA has published regulations governing OTC drugs. In considering whether to allow a drug
to be available OTC through publication of a drug monograph, the agency considers established factors -
safety and effectiveness, the benefit-to-risk ratio, and whether clear and understandable labeling can be
written for self-medication without the intervention of a health professional. See 21 CFR 330.10(a)(4).
Similarly, when considering whether a prescription drug should "switch" to OTC status, the agency
considers related factors such as a consumer's ability to self-diagnose and self-treat, the incidence of side
effects and adverse events, the potential for misuse, and whether the drug's use might mask more serious
conditions that require medical attention. As ASRM has repeatedly asserted, these factors strongly
support approval of OTC Plan B.
<7: 1.2.1, 10>In fact, since Barr filed its application, two studies have been published that address certain
of these factors. Most recently, the British Medical Journal published the results of a survey study of
approximately 7600 women aged 16-49 finding that nonprescription availability of EC in the United
Kingdom did not lead to an increase in unprotected sex, an increase in the use of EC, or a decrease in
"more reliable methods of contraception." Marston, et al., Impact On Contraceptive Practice Of Making
Emergency Hormonal Contraception Available Over The Counter In Great Britain: Repeated Cross
Sectional Surveys. 331 Brit. M.J. 271 (2005). In January 2005, the Journal of the American Medical
Association published the results of a randomized, single-blind, controlled trial of 2117 women, aged 15
to 24 years in which the participants either had pharmacy access to EC, advance provision of Plan B, or
clinical access to EC (control group). The researchers found that access to EC through pharmacies or
advance provision "did not have a detrimental effect on contraceptive use or sexual behavior." Raine et
al., Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy
and STDs, 293 JAMA 54 (Jan. 2005). This information underscores the widespread belief among
women's health professionals that OTC EC would provide tremendous benefits without posing an
unwarranted risk of misuse or adverse health consequences.
<8: 3.9.1, 6.3.4>As the agency recognized in the September 1 ANPR, FDA has allowed marketing of the
same active ingredient in products that are both prescription and OTC where "some meaningful difference
exists between the two that makes the prescription product safe only under the supervision of a licensed
practitioner." 70 Fed. Reg. 52050 (Sept. 1, 2005). FDA provided several examples of such drugs, and
reiterated that the "key distinction" between the OTC and prescription versions of those products is "some
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meaningful difference between the two products," for example, "indication, strength, route of
administration. dosage form." Id.
<9: 3.3.3, 6.3.4>A drug product is approved for those uses set forth in its labeling, the scope of which is
limited to specific statements about the "conditions" of its proper use - those "prescribed, recommended,
or suggested" in the labeling. 21 USC 355(d)(1). Thus, labeling that includes specific limitations on the
appropriate patient population for which the drug is intended can denote a "meaningful difference" in the
prescription drug and the OTC drug product. [Footnote 4: In June 2005, FDA approved a drug for use
only in a specific subpopulation -African Americans. The drug, BiDil(R) (hydralazine hydrochloride;
isosorbide dinitrate), is indicated for the treatment of heart failure as an adjunct to standard therapy in
self-identified black patients. ] Quite simply, levonorgestrel labeled for prescription use is a different drug
that levonorgestrel labeled for OTC use. Indeed, as FDA. acknowledges, it has approved OTC and
prescription versions of a product based on differences in "indication," which constitutes a meaningful
difference in the two products' intended or labeled uses.
ASRM believes that FDA has ample authority to make a similar distinction between prescription and
OTC levonorgestrel and should do so immediately.
<10: 6.4.1>B. FDA Has Ample Authority to Enforce an Age Restriction - both as a Matter of Law and in
Practice
FDA also requested comments on the enforceability of an age limitation for a product sold both by
prescription and over the counter. It is important to note that FDA has approved an sNDA for an "adults
only" OTC version of a prescription product - Nicorette gum. In February 1996, FDA issued an approval
letter for the OTC sale of Nicorette, a smoking-cessation product, for consumers 18 years of age or older.
The letter stated that Nicorette "product cartons must bear the legend: Not for sale to those under 18 years
of age. Proof of age required. Not for sale in vending machines or from any source where proof of age
cannot be verified." See Letter to Hoechst Marion Roussel, Inc. from Paula Botstein, CDER, FDA (Feb.
9, 1996) ("Nicorette Approval Letter (Feb. 9, 1996)"). We are not aware of any challenge - legal or
practical - to FDA's enforcement of this restriction, nor do we foresee any difficulty in enforcing such a
limitation on OTC Plan B.
<11: 6.3.1>1. OTC Levonorgestrel Intended for Use by Women Falling Under the Age Limitation
Would be an "Unapproved New Drug"
The FDCA provides a panoply of legal restrictions on the sale of unapproved new drugs. As a matter of
law, FDA can restrict the "introduction into interstate commerce" of an unapproved new drug such as
OTC Plan B intended for use by a woman under the age of 16.
The statute prohibits the "introduction into interstate commerce [of] any new drug" the approval of which
is not in effect under section 505 of the FDCA. 21 USC 355(a); 331 (d). New drugs are approved by the
agency after evaluation of the results of clinical investigations designed to demonstrate whether the drug
is safe and effective "under the conditions of use prescribed, recommended, or suggested in the proposed
labeling." See 21 USC 355(d). Any new "intended use" of the product by the manufacturer beyond the
use set forth in the labeling requires "adequate directions for use," which are necessarily lacking without
FDA review and approval. See 21 USC 352(f)(1); 21 CFR 201.5; 201.128. Promotion of OTC Plan B to
women under the age of 16 would create an unapproved new drug, as would sale of the product "for a
purpose for which it is neither labeled nor advertised" by persons legally responsible for its labeling. 21
CFR 201.128.
<12: 7.3.1.3, 7.3.1.4>2. FDA Can Enforce An Age Limit As a Practical Matter
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Moreover, FDA can enforce an age limitation through a variety of measures.
FDA routinely requests from drug applicants commitments to implement post-market surveillance and
marketing plans. On approval of Nicorette, for example, the agency stipulated OTC availability for an
adult-only population and requested a number of post- marketing commitments, including a surveillance
study designed to identify and report on sale to or use by people less than 18 years of age. Nicorette
Approval Letter (Feb. 9, 1996). FDA also recently approved a new drug with a post-marketing "risk
management plan" that included a commitment that the manufacturer refrain from using direct-to-
consumer advertising. Letter to Amylin Pharmaceuticals. Inc. from Robert J. Meyer, CDER, FDA (Mar.
16, 2005) (regarding FDA approval of Symlin (pramlintide acetate)). FDA could request that Barr
conduct similar surveillance studies and agree to appropriate advertising limitations. [Footnote 5:
Recently, the Pharmaceutical Research and Manufacturers Association published voluntary principles
governing direct to consumer advertising. See PhRMA Guiding Principles: Direct to Consumer
Advertisements About Prescription Medicines (July. 2005). These establish that such advertisements
"clearly indicate that the medicine is a prescription drug to distinguish such advertising from other
advertising for non-prescription products." They also stress that advertisements "be targeted to avoid
audiences that are not age appropriate for the message involved." ]
<13: 7.3.1.1, 7.3.1.4>Other elements of a possible post-marketing distribution commitments could
include elements such as (1) limitations on "trial size" or "sample" packs; (2) use of child- resistant
packaging; (3) distribution restrictions excluding channels such as convenience stores or vending
machines; (4) incentives to retailers to shelve Plan B close to the pharmacy or with other OTC drugs; and
(5) easy access to patient information regarding use of emergency contraception (toll-free phone number
on labeling). See Nicorette Approval Letter (Feb. 9, 1996).
<14: 7.4.2>And, both Barr and FDA could cooperate with state pharmacy boards and local pharmacies to
ensure enforcement of the age limitation at the point of sale. FDA has entered into memoranda of
understanding ("MOUs") with state regulatory agencies to supplement investigative abilities. See FDA,
Investigations Operations Manual, Ch. 3 (Federal-State Cooperation) at
http://www.fda.gov/ora/inspect_ref/iom/ChapterText/330partl.html#331.02.
In short, FDA has a long record of approving drugs that pose risks to certain populations. It has attempted
to address those risks through agreements with the manufacturer and other enforcement agencies so that
safe and effective drug products could be made available to the public. FDA assessed those risks and
determined that they did not outweigh the benefits such that approval was delayed indefinitely.
Conclusion
For all these reasons, and those included in ASRM's previous submissions to Docket No. 2001P-0075, we
urge FDA to approve Plan B for OTC use.
Sincerely,
Joseph S. Sanfilippo, M.D.
President
American Society of Reproductive Medicine
Robert W. Rebar, M.D.
Executive Director
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American Society of Reproductive Medicine
COMMENT NUMBER - 2005N-0345-C403
2005N-0345-C403 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Arnall Golden Gregory LLP
2005N-0345-C403 - TEXT
Arnall Golden Gregory LLP
Direct phone: 404.873.8690
Direct fax: 404.873.8691
e-mail: alan.minsk@agg.com
www.agg.com
October 31, 2005
VIA FEDERAL EXPRESS &
FACSIMILE 301.827.6870
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Room 1061 (HFA-305)
Rockville, Maryland 20852
Re: Docket No. 2005N-0345 ("Drug Approvals: Circumstances Under Which An Active Ingredient May
Be Simultaneously Marketed In Both A Prescription Drug Product And An Over-the Counter Drug
Product")
To Whom It May Concern:
On behalf of a client, Arnall Golden Gregory LLP submits these comments, in triplicate, in response to
the Food and Drug Administration's Advance Notice of Proposed Rulemaking (ANPR) regarding
circumstances under which an active ingredient may be simultaneously marketed in both a prescription
drug product and an over-the-counter drug product (Docket No. 2005-0345). Our client manufactures and
distributes both prescription and OTC drug products.
Background
On September 1, 2005, FDA issued an ANPR to request comment on whether to initiate rulemaking to
codify its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act (FDC Act), 21
U.S.C. § 353(b), 70 Fed. Reg. 52050. Section 503(b) identifies the standard used to classify drugs as
prescription or OTC. 21 U.S.C. § 353(b). In addition, this statutory provision describes when and how to
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switch a drug from prescription to OTC status. Id.
According to the FDC Act, a prescription drug is:
(1) A drug intended for use by man which -
(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the
collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner
licensed by law to administer such drug; or
(B) is limited by an approved application under section 505 to use under the professional supervision of a
practitioner licensed by law to administer such drug.
21 U.S.C. § 353(b)(1). FDA noted in the ANPR that it has:
interpreted the language in section 503(b)(1) of the act to allow marketing of the same active ingredient in
products that are both prescription and OTC, assuming some meaningful difference exists between the
two that makes the prescription product safe only under the supervision of a licensed practitioner.... To
date, FDA has not allowed marketing of the same active ingredient in a prescription product for one
population and in an OTC product for a subpopulation.
70 Fed. Reg. at 52051.
The FDC Act does not explicitly define OTC drugs. FDA states:
A drug shall be permitted for OTC sale and use by the laiety unless, because of its toxicity or other
potential for harmful effect or because of the method or collateral measures necessary to its use, it may
safely be sold and used only under the supervision of a practitioner licensed by law to administer such
drugs.
See 21 C.F.R. § 330.10(a)(4)(vi); see also 21 C.F.R. § 310.200. OTC drugs typically have these
characteristics:
their benefits outweigh their risks;
the potential for misuse and abuse is low;
consumer can use them for self-diagnosed conditions;
they can be adequately labeled; and
health practitioners are not needed for the safe and effective use of the product.
Comments to ANPR
FDA requested comments to specific questions concerning interpretation of section 503(b) of the FDC
Act. Before we provide our recommendations, we want to commend the agency for requesting and
considering industry input. We appreciate that any decisions made by FDA must first focus on patient
safety.
<1: 3.8.2, 3.8.5, 3.8.6>In general, the current system appears to work well. FDA has the authority and
flexibility to require unique, product-specific information on a case-by-case basis, and may consult with
expert advisory committees, where appropriate. We believe it would be useful for FDA to issue more
written guidance to explain further its interpretation of section 503(b), but we recommend that the
guidance remain that - guidance, and not rulemaking - so that industry can better understand the agency's
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current thinking, without limiting both FDA and companies to a one-size-fits-all approach. While not
specifically addressed in this request from FDA, we also suggest that the agency consider, as it formulates
its policy in this context, the intermediate designation approach of "behind-the-counter" ("BTC") sale and
distribution.
Question 1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the FDC Act
regarding when an active ingredient can be simultaneously marketed in both a prescription drug product
and an OTC drug product?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the FDC Act?
C. If so, would a rulemaking on this issue help dispel that confusion?
Response
<2: 3.3.2, 3.8.5>The short answer is no; FDA should not initiate formal rulemaking in this case. The FDC
Act clearly identifies when a drug product is for prescription use only. On the other hand, the
circumstances under which a product may be considered safe and effective for OTC use vary according to
product type and should be reserved for a case-by-case evaluation, e.g., a new drug application or
monograph. For example, the amount of safety information that may be needed to allow the OTC sale of
statins would be far different from that required for the OTC sale of antihistamines.
<3: 3.8.6>As previously noted, we do not see much benefit from formal rulemaking here. However, it
would be useful for FDA to issue a clear guidance document to outline the current interpretation by the
agency of the circumstances under which an active ingredient may be simultaneously marketed in both a
prescription and an OTC product. This guidance could include some recommendations about the amount
of safety information that might be required in a marketing application and the format in which it should
be presented to FDA. In addition, the written guidance should contain criteria that FDA will consider
when evaluating whether there is a "meaningful difference" between a prescription and an OTC drug
product.
Another issue that FDA might address in any guidance that it develops is the control of access to certain
medications that could be abused or may require additional input from a learned intermediary who is not a
physician, such as a pharmacist.
Question 2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
B. If it could, would it be able to do so as a practical matter and, if so, how?
Response
<4: 7.4.1, 7.5.3>We believe it will be difficult for FDA to restrict or limit sale based on subpopulation.
The example that seems to be the most apparent would be to allow a product to be OTC for adults, but by
prescription only to the pediatric population. The point of having a prescription-only product is an attempt
to ensure the safety of the patients taking or using the particular product by involving a physician. It
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would appear to be impractical to allow and enforce OTC access for one subpopulation if FDA concludes
the product should be not be available for OTC use in other subpopulations. Again, the agency might
consider the intermediate approach of BTC sale and distribution, where the intervention of a learned
intermediary, such as a pharmacist, could help ensure that the patient self-administers the product
safely.
Question 3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
Response
<5: 8.6.1, 8.6.2, 8.9>We interpret FDA's question to focus on whether a company may use similar
packaging for products where the same active ingredient is contained in both a prescription and an OTC
product. We believe this should not be done. [Footnote 1: We do not understand FDA to ask whether a
prescription and an OTC drug product with the same ingredient may be sold together in the same physical
package. If this is part of the question, we recommend against such packaging.] Marketing the same
active ingredient as a prescription and an OTC product in similar packaging seems to be contrary to the
meaningful difference standard. Separate packaging styles make clear that the products are not the same.
For the pharmacist who is dispensing products, similar packaging potentially increases the likelihood of
medication errors rather than decreases them. In addition, a prescribing physician may be unaware of the
packaging similarities, which could lead to prescribing errors, and thereby lead to a potentially unintended
and adverse result on patient safety.
Thank you for the opportunity to submit these comments. Please feel free to contact us
if you have any questions.
Respectfully submitted,
ARNALL GOLDEN GREGORY LLP
Alan G. Minsk
Arnall Golden Gregory LLP
171 1 7th Street, NW
Suite 2100
Atlanta, Georgia 30363
(404) 873.8690
(404) 873.8691 (Fax)
AGM:rlh
COMMENT NUMBER - 2005N-0345-C407
2005N-0345-C407 - STRUCTURED DATA ELEMENTS
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Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Pfizer, Inc.
2005N-0345-C407 - TEXT
Wiley Rein & Fielding LLP
1776 K STREET NW
WASHINGTON, DC 20006
PHONE 202.719.7000
FAX 202.719.7049
Virginia Office
7925 JONES BRANCH DRIVE
SUITE 6200
McLEAN,VA 22102
PHONE 703.905.2800
FAX 703 905.2820
www.wrf.com
Bert W . Rein
202.719.7080
brein@wrf.com
November 1, 2005
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Pfizer Inc Comments on Docket No. 2005N-0345; Advance Notice of Proposed Rulemaking on
Simultaneous Marketing of an Active Ingredient in Both a Prescription Drug Product and OTC Drug
Product, 70 Fed. Reg. 52050 (Sept. 1, 2005)
The undersigned, on behalf of Pfizer Inc, submit these comments in response to the Food and Drug
Administration's ("FDA") Advance Notice of Proposed Rulemaking requesting comments on the
"Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a
Prescription Drug Product and an Over-the-Counter Drug Product" ("the ANPRM "). Pfizer recognizes
that FDA's Advance Notice arises out of a specific controversy of great concern to many interested
parties. Pfizer is not involved in that controversy and takes no position as to its proper resolution under
the Federal Food, Drug, and Cosmetic Act ("FDCA") and public health. Pfizer is filing these comments
because the ANPRM raises broad issues about the authority vested in FDA under Section 503(b) of the
FDCA. As a manufacturer of both prescription drug ("Rx ") and over-the-counter ("OTC ") drug products,
Pfizer is filing these comments to assist FDA in its analysis of the Agency's statutory authority under
Section 503(b).
I. Statutory Requirements
FDA's role in regulating prescription versus OTC dispensing of drugs is set forth in Section 503(b) of the
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FDCA. That section was added to the statute in 1951 by the Humphrey-Durham Amendments. [Footnote
1: Humphrey-Durham Drug Prescriptions Act, Pub. L. No. 82-215, 65 Stat. 648 (1951) (amending 21
U.S.C. § 353(b)).] Prior to Humphrey-Durham, FDA had no authority to determine whether drugs were
required to be dispensed by prescription or sold OTC. Such determinations were left solely to the
discretion of drug manufacturers.
A. Concerns Giving Rise To The Humphrey-Durham Amendments.
The lack of a regulatory standard prior to the passage of the Humphrey- Durham Amendments for
requiring drugs to be dispensed only by prescription led to a number of health and safety concerns.
[Footnote 2: See H.R. REP. No. 82-700, at 6 (1951)]
Congress found that lack of a clear standard for the drugs which should be limited to prescription
distribution resulted in "many cases of indiscriminate and unauthorized over-the-counter sales of
dangerous drugs and other drugs which should be used only under medical supervision." [Footnote 3: Id.]
At the same time, as FDA states in the ANPRM, retail pharmacists and the public faced "burdensome and
unnecessary restrictions on the dispensing of drugs that [were] safe for use without the supervision of a
physician." [Footnote 4: Advanced Notice of Proposed Rulemaking, 70 Fed. Reg. 52050, 52051 (Sept. 1,
2005).]
Pharmacists were often confused about how particular products should be sold. Because many
manufacturers were failing to provide adequate directions for consumer use with drugs not labeled for
"prescription-only" use, pharmacists were concerned about liability for improperly dispensing a drug that
the manufacturer had not labeled properly for OTC use or that was meant to be limited to prescription
sale. [Footnote 5: Hearings Before the S. Subcomm. on Health of the Comm. on Labor & Public Welfare
on S. 1186 and H. R. 3298, 82d Cong. 52 (1951) (statement of Roy S. Warnack, Retail Druggist).] They
wanted a reformed scheme that would "take the guesswork out of labeling" by making it clear which
drugs could be dispensed only on prescription and mandating that manufacturers of a drug not labeled
with the prescription legend "must label the drug to meet all of the labeling requirements of the [FDCA]
and that the product can lawfully be sold over the counter." [Footnote 6: Id at 50. ]
A related lack of uniformity in how the same drug was labeled and sold by different manufacturers led to
dozens of drugs containing the same active ingredient and dosage form on the market bearing different
labeling; some brands were labeled for prescription sale, some for OTC distribution. [Footnote 7: Id. at
6-7, 53 (providing examples of drugs being sold both prescription and OTC, including quinidine sulfate,
theobromine with sodium salicylate, dehydrochloric acid, iron tablets, and tincture of hyoscyamus); H.R.
REP. NO. 82-700, at 5-6. ]
<1: 3.3.3>B. The Authority Granted to FDA Under Humphrey-Durham.
The specific authority Congress granted to FDA in the Humphrey-Durham Amendments in response to
these concerns is of critical importance as FDA considers the issues it raises in the ANPRM. The agency
must look to the precise authority Congress provided in the statute itself.
New Section 503(b)(1) directly addressed the protection of consumers from the dangers arising from OTC
dispensation of drugs which could not safely be used without physician supervision. That section forbade
the OTC sale of any drug which FDA determined "because of its toxicity or other potential for harmful
effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except
for under the supervision of a practitioner licensed by law to administer such drug." [Footnote 8: 21
U.S.C. § 353(b)(1); see also S. REP. NO. 82-946, at 4 (1951), reprinted in 1951 U.S.C.C.A.N. 2454,
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2456. Section 503(b)(1) also initially barred OTC sale of habit-forming drugs subject to Section 502(d)
and drugs determined to require prescription dispensing in a Section 505 application process. 65 Stat. at
648. However, the provision relating to habit-forming drugs was eliminated when Section 502(d) was
repealed in 1997. Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-l 15, § 126,
111 Stat. 2296, 2327-2328 (1997).]
<2: 3.3.3, 8.5.1>New Section 503(b)(2), supplemented by Section 503(b)(4), addressed the problem of
pharmacists needing guidance on how a drug could be lawfully marketed. Under Section 503(b)(2) and
(4), a drug required by FDA to be marketed under prescription was required to have "Rx only" on its
label, thus: (a) exempting it from any statutory duty to have adequate directions for consumer use and (b)
making it unlawful for a pharmacist to dispense it without a prescription. [Footnote 9: 21 U.S.C. §§
353(b)(2); (b)(4).] A drug not required by FDA to be dispensed under prescription could not bear the "Rx
only" mark and could be sold OTC if the manufacturer supplied adequate instructions for consumer use.
[Footnote 10: 21 U.S.C. §§ 353(b)(4); 352(f).] The instruction requirement was expressly made
inapplicable to all prescription drug sales, including both those with "Rx only" on the label and those
requiring prescription by manufacturer direction. [Footnote 11: Id. at § 353(b)(2), stating: "Any drug
dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to
administer such drug shall be exempt from the requirements of Section 502 [which includes the
requirement for adequate directions for consumer use] . . . ." This definition applies to all drugs dispensed
by a prescription, rather than only those required to be labeled "Rx only" under 21 U.S.C. §
353(b)(4)(A).]
Accordingly, the presence of the "Rx only" symbol advised pharmacists that FDA required a drug to be
dispensed with a prescription so that the pharmacist could avoid the legal risks of selling it OTC.
Although manufacturers choosing voluntarily to dispense by prescription could not use the "Rx only"
symbol, they would have to label their drugs with FDA-approved prescription labeling, and could not put
pharmacists in terrorem with respect to selling identical drugs sold OTC because the absence of the "Rx
only" symbol made it clear that OTC dispensation was FDA sanctioned. [Footnote 12: Pursuant to 2 1
C.F.R. § 201.100(c)(1), prescription drug labeling - in lieu of OTC adequate directions for consumer use -
is required to contain adequate information for use of the drug at the dosage and for the indications
recommended, prescribed or suggested in such labeling under which practitioners licensed by law to
administer the drug can use the drug safely and for the purposes for which it is intended.]
<3: 3.3.3>New Section 503(b)(3) addressed Congress' concern that consumer access to OTC medication
not be unduly impaired. The section required FDA to reverse a Section 503(b)(1) determination that a
drug be dispensed by prescription only through a rulemaking process "when such requirements are not
necessary for the protection of the public health." [Footnote 13: 21 U.S.C. § 353(b)(3).] Thus, when new
scientific evidence establishing that OTC dispensation would be safe came to FDA's attention, FDA, on
request or at its own initiative, could remove mandatory prescription requirements. A removal of the
requirement foreclosed manufacturers from applying the "Rx only" mark, so that pharmacists and other
concerned individuals could be made aware that FDA no longer required prescription sale. Manufacturers
were also free to propose OTC labeling since OTC distribution was no longer barred. However, nothing
in the section prohibited a manufacturer from continuing to limit distribution to prescription-only at its
own discretion, as long as the drug continued to have approved prescription labeling and the "Rx-only"
mark was not used.
II. Response to Specific Questions Raised in the ANPRM
<4: 3.3.3>A. The ANPRM's inquiry about the circumstances under which an active ingredient may be
simultaneously marketed both as a prescription and OTC drug can be answered directly from Section
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503(b).
1. Multiple formulations with different safety profiles are to be sold. Simultaneous Rx/OTC marketing
may occur where there are multiple formulations, the manufacturer seeks to market one or more such
formulations without an Rx restriction and FDA determines in its review of the manufacturer's application
that one or more formulations, but less than all, must be restricted to "Rx-only". In addition, if FDA
determines either initially or in a subsequent 503(b)(3) rulemaking that no "Rx-only" designation is
required and the manufacturer exercises its right to confine distribution of one or more such formulations
to prescription status, simultaneous Rx/OTC marketing is authorized.
<5: 6.3.1>2. The drug will be marketed to a subpopulation requiring the supervision of a licensed
practitioner. Simultaneous Rx/OTC marketing may occur where the manufacturer seeks to label and sell a
formulation to a population which includes a sub-population which FDA determines cannot use the drug
safely without the supervision of a licensed practitioner but can use it safely on an "Rx-only" basis. In
addition, if FDA determines either initially or in a subsequent 503(b)(3) rulemaking that no "Rx-only"
designation is required for use by a subpopulation and the manufacturer exercises its right to confine
distribution of one or more such formulations to prescription status, simultaneous Rx/OTC marketing is
authorized.
As noted in the ANPRM, FDA's determinations under 503(b)(1) and 503(b)(3) may take into account
"meaningful differences" in indications for use, active ingredient levels, dosage forms and routes of
administration. [Footnote 14: Advanced Notice of Proposed Rulemaking, 70 Fed. Reg. at 52051.] Unless
those differences lead to an "Rx-only" determination, however, the ultimate decision on prescription
versus OTC marketing lies with the manufacturer.
<6: 3.3.3, 3.8.7>B. The ANPRM inquires whether a rulemaking to codify FDA's approach would be
appropriate. Pfizer does not believe that an expenditure of agency resources on such an endeavor would
be justified. Any attempt to describe how FDA would resolve specific safety issues under Sections
503(b)(1) and 503(b)(3) or adequacy of labeling issues under 503(b)(2) would be a complicated
undertaking which could either unduly constrain future scientific judgments or result in statements at a
level of generality which would be unlikely to advance public understanding of the review process
beyond that already established in the Congressional mandate in Section 503.
<7: 6.3.1>C. The ANPRM last inquires whether FDA would be able to enforce, as both a matter of law,
and a practical matter, a limitation on OTC sales of a product to a particular subpopulation. FDA's ability
to enforce such limitation is based on its authority under the Federal Food, Drug, and Cosmetic Act.
FDA is authorized and mandated under Section 502(f) to ensure that OTC labeling permits a drug product
to be used safely. [Footnote 15: 21 U.S.C. § 352(f).] If the product labeling does not adequately inform
the intended population (or a specific and targeted subpopulation) of a known vulnerability, FDA can and
should require an appropriate label modification to ensure that the directions are adequate. FDA is, in
fact, working on standards which will better communicate risks and use instructions to all consumers.
[Footnote 16: See, e.g., FDA, Guidance, Useful Written Consumer Medication Information (CMI) (draft
posted May 25, 2005), available at http://www.fda.gov/cder/guidance/6520dft.pdf; FDA, Guidance for
Industry, Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (draft
posted Feb. 4, 2004), available at http://www.fda.gov/cder/guidance/5669dft.pdf.]
When FDA is satisfied that the label properly communicates to the relevant subpopulation an effective
warning, use contraindication, or other significant safety information it has fulfilled its Congressional
mandate and reached the limit of its authority. <8: 6.5.1>FDA has no relevant regulatory
authority over consumers or resellers and is not responsible for the elimination of intentional abuse.
State and local agencies, on the other hand, have both the authority and resources to enforce FDA
mandated labeling restrictions, including limitations at point of sale, and have undertaken that task, most
recently with respect to certain cold medications. There is no reason for FDA to disturb this
Congressionally-mandated division of responsibilities and enforce point-of-sale labeling restrictions on
use.
Respectfully submitted,
Bert W. Rein
Andrew S. Krulwich
WILEY, REIN & FIELDING LLP
1776 K Street, N. W.
Washington, D.C. 20006
Telephone: (202) 719-7000
Facsimile: (202) 719-7207
Counsel to Pfizer Inc
COMMENT NUMBER - 2005N-0345-C412
2005N-0345-C412 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Consumer Healthcare Products Association
2005N-0345-C412 - TEXT
Consumer Healthcare Products Association
October 31, 2005
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, room 1061
Rockville, MD 20852
Re: Docket No. 2005N-0345
FDA Request for Comments on Advance Notice of Proposed Rulemaking, "Drug Approvals:
Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in both a
Prescription Drug Product and an Over-the-Counter Drug Product," 70 Fed. Reg. 52050-51 (September
1, 2005)
Dear Sir or Madam:
In the September 1, 2005, Federal Register, the Food and Drug Administration invited comments on the
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above-referenced advance notice of proposed rulemaking (ANPR), regarding circumstances under which
an active ingredient may be simultaneously marketed in both prescription and nonprescription, or over-
the-counter (OTC), drug products.
The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade
association representing manufacturers and distributors of OTC medicines and dietary supplements in the
United States. CHPA members account for over 90 percent of the domestic retail sales of OTC
medications. As such, we have an interest in the subject matter of the ANPR. CHPA sees no need for the
agency to initiate a rulemaking on this matter. Sufficient precedent already exists for an active drug
ingredient to be simultaneously marketed in both prescription and OTC drug products based on narrow
distinctions.
The comments below use the numbering and lettering for questions on which FDA has invited comments
(see 70 Fed. Reg. 52051 [September 1, 2005]).
<1: 3.3.2, 3.8.4>1.A. FDA does not need to initiate a rulemaking to codify its interpretation regarding
when an active ingredient can be simultaneously marketed in both a prescription and OTC drug product,
since ample precedents already exist to guide the agency and the public. As the agency notes in the
background information of this ANPR, the 1951 Durham-Humphrey Amendments to the Food, Drug, and
Cosmetic Act removed the confusion that had existed prior to that time when different manufacturers
made different decisions about whether to market a drug as prescription or OTC. Under the Durham-
Humphrey Amendments, the same drug, at the same dosage form and strength, and for the same
indication, cannot simultaneously be available on a prescription and nonprescription basis.
But since the Durham-Humphrey Amendments, FDA has needed to draw fine distinctions among dosage
forms, methods of administration, or indications or uses to regulate an ingredient differently in different
settings. These fine distinctions are not limited to whether and when a drug ingredient is prescription or
OTC. They run across a gamut of issues, from a product's primary mode of action to whether something
is a food, drug, biologic, device, cosmetic, or some combination of them, from whether something is
generally recognized as safe and effective or whether it requires a new drug application to other fine
distinctions. The commonality in drawing these distinctions, and the very reason for drawing them,
balances on whether or not an ingredient is the same thing in two related settings.
<2: 3.3.2>While FDA has established rules to help guide both interested parties and the agency in
walking the line between various distinctions on what is or isn't the same and what triggers different
treatment, there is no mandate to do so in every instance. In the case of the instant question of
prescription and OTC status, there is no need for a rule, as there are ample precedents to give interested
parties paths to follow to distinguish among different labeling requirements, leading to a drug active
ingredient in two or more settings not being the "same," even if an outside observer less familiar with the
nuances involved would not immediately see the distinctions. There are any number of instances where
an active ingredient is seen as an OTC drug in one dosage form and strength for a specified indication(s),
and also has uses or additional labeling under consultation with a health professional, whether those
different uses or labeling are termed prescription use, professional labeling, professional information, or
even off-label use.
<3: 3.9.1>The examples which follow provide a partial, not exhaustive, list of those instances where a
particular ingredient is seen as an OTC drug in one or more settings, but is a prescription drug or includes
prescription labeling, professional labeling, or professional information in others.
(1) Dosage strength variations. As FDA notes in the ANPR, ibuprofen and H2 blockers are both
examples in which an active ingredient is prescription in one strength and OTC in another. While FDA
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also pointed to more readily distinguished differing strengths and indications for the prescription or OTC
ibuprofen and H2 blocker examples in the ANPR, one can also point to dosage strength variations where
the distinctions between the prescription and OTC versions are finer. For example, prescription-strength
2.5 percent hydrocortisone cream is indicated for relief of inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses. OTC 1.0 or 0.5 percent hydrocortisone cream is indicated for
temporary relief of itching associated with minor skin irritations, inflammations, and rashes due to a
number of listed inflammatory and pruritic conditions, i.e., indications closely related to the higher-dose
prescription indication.
As another example, the directions for OTC ibuprofen start at 200 mg, and go up to 400 mg per dose, for
aches, pains (including the pain of menstrual cramps), minor pain of arthritis, and reduction of fever.
While higher strengths of prescription ibuprofen are available, prescription strength formulations start at
300 mg, between the two OTC doses. In addition, arthritis, including flare-ups of chronic disease, mild to
moderate pain, and primary dysmenorrheal are prescription indications. These indications are closely
related to the OTC indications.
<4: 3.9.1>(2) Indication variations. In addition to dosage strength variations (some of which include
very similar indications, including the examples mentioned earlier), there are prescription and OTC
variations based on the indication using the same dosage strength. Ibuprofen again provides an example,
where children's ibuprofen is available OTC for children down to 6 months of age in a suspension --100
mg/5 mL - to temporarily reduce fever or to relieve minor aches and pains due to listed common
conditions. The same strength is available as a prescription for children down to 6 months of age for
reduction of fever, for relief of mild to moderate pain, and for relief of signs and symptoms of juvenile
arthritis. Setting aside the juvenile arthritis indication, which can be readily distinguished, the OTC
"'temporarily' reduces fever" indication versus the open-ended prescription "reduction of fever," and the
OTC minor aches and pains versus the prescription mild to moderate pain indications illustrate the fine
line between two products distinguished as not being the "same."
Clotrimazole is a second example, where 1 percent topicals are available: OTC for athlete's foot, jock
itch, or ringworm; OTC for treatment of recurrence of symptoms matching a previously diagnosed
vaginal yeast infection; and prescription for treatment of candidiasis due to Candida albicans and tinea
versicolor due to Malassezia furfur. (There are differing creams, lotions, solutions, or delivery vehicle
variations in this example. There are also additional strengths for different treatment durations for vaginal
yeast infections.) Again, OTC labeling for recurring vaginal yeast infections versus the prescription
labeling for open-ended occurrence/recurrence and with reference to more specific causes of the condition
draws a fine line between related contexts that aren't seen as the same. It is worth noting that the first
reference to the fact that the OTC product is for recurring infections does not occur in the "use" section of
the OTC outer package label. Rather, the direction to consult a doctor if this if the first vaginal itch
situation occurs under "warnings" - a different section of the OTC "Drug Facts" label from the "use"
section.
<5: 3.9.1>(3) Professional labeling approaches. Under the OTC Review monograph system, many
ingredients or classes of ingredients that are generally recognized as safe and effective (GRAS/GRAE)
include professional labeling. While it is true that the OTC products with these ingredients are not
technically prescription products at the same time, the limitation that this professional labeling is to be
provided to health professionals but not to the general public serves the same practical intent: it
distinguishes between OTC information (i.e., those uses that are safe and effective for consumers, or
information intended to provide for safe and effective use by consumers on the basis of labeling), and
information or uses that are intended to be limited to use under the professional supervision of a health
practitioner because of potentiality for harmful effect; method of use; or collateral measures necessary to
use (i.e., factors in the definition of a prescription drug under 503(b)(1)). Among the many monographs
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or tentative final monographs with professional labeling are:
- Antacids: Professional labeling for antacids includes additional details on the neutralizing capacity of
the product in terms of dosage per minimum time interval; additional indications (for specific disease
states or, for certain ingredients, low phosphate diets); additional warning information on kidney disease
for certain ingredients where the OTC label includes a contraindication for kidney disease; and additional
warning information on prolonged use for certain ingredients where the OTC label includes a duration of
use warning. See 21 CFR sec. 331.80 (April 2004) on professional labeling, and 21 CFR sec 331.30
(April 2004) on OTC labeling of antacid products.
- Antiflatulent: Professional labeling here distinguishes between the basic OTC indication to relive gas
symptoms and indications tied to a particular subpopulation's state: gas pain in postoperative or
endoscopic exam settings. See 21 CRF sec. 332.31 (April 2004) on professional labeling compared and
contrasted to OTC labeling at 21 CFR 332.30.
- Topical antifungals: Professional labeling for a specific antifungal ingredient includes an additional
indication for superficial skin infections caused by yeast (candida albicans). See 21 CFR 333.280 (April
2004) on professional labeling compared and contrasted with the OTC indications for athlete's foot, jock
itch, and ringworm at 21 CFR 333.250.
- Cough, cold, allergy, brouchodilator, and antiasthmatic OTCs: Here again professional labeling
includes additional information that may be provided to health professionals, but not to the general public,
in this instance focused on age distinctions, including dosage schedules for children 6 years of age to 12,
and children 2 to under 6. See 21 CFR 341.90 (April 2004). Similar to the case of antiflatulents,
professional labeling in this category includes a narrow distinction within the indication for an
expectorant tying the expectorant to an underlying condition, but without changing the basic indication:
"'helps loosen phlegm (mucus) and this bronchial secretions to' (select one or more of the follow: 'rid the
bronchial passageways of bothersome mucus,' 'drain bronchial tubes,' and 'make coughs more
productive')" for the OTC indication compared or contrasted with professional labeling that the
expectorant "'helps loosen phlegm and thin bronchial secretions in patients with stable chronic
bronchitis.'" (Emphasis added.) Compare and contrast 21 CFR 341.78 (April 2004) for OTC expectorant
labeling with 21 CRF 341.90(d) for professional labeling.
- Miscellaneous internal OTC products: Cholecystokinetic drug products are GRAS/E for OTC use, and
again a distinction is made between consumer labeling and labeling provided to health professionals but
not to the general public. Here, the consumer's OTC indication is for the contraction of the gallbladder
during diagnostic gallbladder studies, and consumers are directed to take the product only when instructed
by a doctor. Left to professional labeling is a description of the implicit 'how' (visualization) of the OTC
indication's explicit 'what' (for diagnostic studies): "For visualization of biliary ducts during
cholecystography." See 21 CFR 352.350 on OTC labeling and 352.280 on professional labeling. In this
final example, there is not free-standing separate indication, or no separate dosage from or strength, to
distinguish between the OTC use and the professional (i.e., prescription-like) use. Indeed, in this
example, OTC would be predicated on the ultimate professional use. The example yet again illustrates
the fine line that can be drawn.
With OTCs subject to a new drug application, FDA has also worked with companies on professional
labeling or professional information within approved labeling. For example, at least one of the H2s
include not only strength or indication differences between prescription and OTC versions of the
ingredient, but professional information for the OTC version discussing pharmacokinetic interactions.
Overdosage information provided as professional information in labeling for a number of OTC internal
analgesics or antidiarrheals are further illustrations.
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<6: 3.9.1>(4) Age distinctions. As covered in the discussion above on professional labeling, age is
frequently used to distinguish either OTC labeling from prescription labeling for the same active
ingredient, OTC labeling from professional labeling or professional information, or OTC labeling from an
off-label use a physician could choose to prescribe for a patient.
In addition to the GRAS/E OTC ingredients discussed earlier, another example would be nicotine replace
therapy, where the directions advise potential users to ask a doctor before use if under 18 years of age.
NRT products are further labeled as not for sale to those under 18 years or age, and labeling states that
proof of age is required. While a version of these products is not labeled for prescription use for those
under 18, a doctor, upon being asked, could chose to prescribe a NRT product within their own practice
of medicine.
The same can be said for minoxidil in either 5 percent strength for men, or 2 percent strength for women,
where the labels warn against use if you are less than 18 years old.
Clotrimazole for recurring vaginal yeast infections of H2s for heartburn are further examples along the
lines of NRT and minoxidil, this time with labeling for use in those 12 and over. (Clotrimazole for
athlete's foot, jock itch, and ringworm, meanwhile, warnings against use on children under 2.)
In the case of H2s, similar to NRT, the OTC directions are to ask a doctor for children under 12. How a
doctor might respond is not addressed, instead being left to their discretion within the practice of
medicine. (Meanwhile, prescription versions of the H2s exist in a variety of other strengths.)
Age distinctions for children who are 6 years of age versus those under 6 are even more common. In
addition to the GRAS/E illustrations given earlier, the antidiarrheal lopcramide, with OTC directions to
ask a doctor before use in children under 6 years of age, includes a professional dosage schedule for
children 2-5 years old.
<7: 3.9.1>(5) Gender distinctions. Distinctions have also been drawn between ingredients in OTC
products versus other, prescription, professional information, or presumably off-label uses based on
gender. Clotrimazole, discussed earlier, would be one example. Minoxidil would be another.
Minoxidil 5 percent topical solution to help regrow hair is indicated for use in men, and includes
warnings against use by women (at the same time, it is not exempt from a general OTC warning to seek
the advice of a healthcare professional if the user is pregnant or nursing a baby). Minoxidil 2 percent,
meanwhile, is marketed under a brand including a descriptor within the brand name of "For Women."
The labeling, however, includes no uses, warnings, or directions limiting its use to women. Earlier
versions of OTC minoxidil 2 percent included separate packages and separate labeling for a brand
including "for Men" within its brand name, and a version including "for Women" within its brand name.
With earlier versions, warnings were included on the "for Women" brand specific to women that were not
included in the "for Men" brand (such as the pregnancy/nursing warning). Compare and contrast the "for
Men" and "for Women" versions as published in Physicians' Desk Reference for Nonprescription Drugs
(1997 edition, Medical Economics). While there neither were not are simultaneous prescription and OTC
versions of an ingredient in the minoxidil example, it nonetheless again points to the ability of
manufacturers and FDA to draw fine distinctions between two items to make them not the same.
<8: 4.4.2>B. and C. Given the precedents that already exist, there should not be significant confusion
regarding section 503(b), so the question of dispelling confusion is moot. As discussed above,
distinctions - some broad, some narrow - have been used for a range of ingredients to allow the
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ingredients to be labeled and marketed in more than one way, so there should not be significant confusion
regarding section 503(b). A range of paths and precedents exist for both the agency and those wishing to
label and market a drug product. The question of dispelling confusion is moot.
<9: 6.5.1>2. A. and B. Existing law is clear as to what parties the Food, Drug, and Cosmetic Act applies,
and existing practice and precedent already recognizes this, already answering the question of whether or
how FDA can limit OTC sale of a product to a particular subpopulation. FDA's question as to the
practicality of enforcing a limitation on prescription versus OTC status misses the mark. Whether one
likes to admit it or not, the Food, Drug, and Cosmetic Act does not and cannot apply to every setting in
which any FDA-regulated product is ultimately used. FDA does not regulate the practice of medicine.
Apart from limited exceptions, FDA does not control the practice of pharmacy. FDA cannot control the
behavior of individual citizens, and that is true whether an active ingredient is OTC, prescription, or both.
[Footnote 1: As just one example on the non-use of medicines, two out of five senior citizens said they
hadn't taken all the medicines their doctors prescribed for them over the year before being surveyed --
either because they didn't think the drugs were helping them, they didn't think they needed them, or they
were concerned about costs. See Safran, et al., "National Survey of Seniors and Prescription Drugs,
2003," available in Health Affairs online edition, April 2005,
http://content.healthaffairs.org/cgi/reprint/hlthaff.w5.152v1?ijkey=Gn1EKoVVrGMv.&keytype=ref&sitei
d=healthaff.] FDA does, of course, have an obligation to protect and advance the public health by
assuring that drugs are safe, effective, and appropriately labeled. Similarly, our members, as
manufacturers of OTC medicines, not only have to meet FDA requirements, but also work to encourage
consumers to use their products responsibly in accordance with labeling, and have a need to determine the
intended use of their products.
<10: 6.3.5>While one can speculate as to what has changed in 2005 to raise the question of FDA's ability
to enforce a labeling limitation to a particular subpopulation, the fact remains that this issues has always
been present. The issue is present when a child is 5 years and 363 days old versus 6, not quite 12 versus
12, or not quite 18 versus 18. It is present when a potential user is a man or a woman. It is present when a
condition is occurring temporarily or for the first time versus when it is for a chronic condition or
recurring. Yet this is not to say manufacturers or FDA is without means to test, encourage, and improve
concordance with label directions. Over generations, the tests and measures by which a manufacturer's
and FDA's best intentions for how a product can and should be used have grown. For the current
generation of prescription-to-OTC switches, label comprehension studies and actual use studies have
become the norm, or at least the norm for early entrants into a new category. Label comprehension
studies seek to assure that a proposed OTC label adequately communicate -- i.e. that people understand it
-- by testing label versions through an interactive process, with variations in wording, emphasis, or
positioning of information. Actual use studies try to simulate the OTC purchase environment by limiting
healthcare provide involvement and removing the trial from the clinical setting. The focus of actual use
studies is on self-selection (i.e., do the appropriate people chose to use the product and do the
inappropriate people deselect, or chose not to use the product), compliance with package labeling, and
safety in a minimally supervised environment. Label comprehension, self-selection, or actual use studies
have been publicly considered and discussed at FDA advisory committee meetings concerning proposed
prescription-to-OTC switches (be they successfully switched, rejected, or pending) for ingredients such as
minoxidil, cholesterol-lowering therapies, an analgesic for a migraine indication, a muscle relaxant, a
contraceptive sponge, omerprazole, and levonorgestrel, among others.
FDA officials (noting the opinions expressed are those of the speaker, and do not necessarily represent
those of the Food and Drug Administration) have discussed the usefulness (including value and
limitations) of the label comprehension or actual use studies at a range of meetings, including Drug
Information Association meetings, CHPA Regulatory and Scientific Conferences, and others.
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The point is that manufacturers and FDA are working toward improved understanding and predictability
in how consumers understand and intent to use OTC medicines. We are better equipped today than in the
past to assess how well new products will measure up against that goal.
<11: 8.8>3. A. It is not clear whether or not different marketed and specifically distributed Rx and OTC
products may be sold in the same package, but it is clear that prescription uses for a specific OTC product
can be accomplished with one package. The agency asks whether, assuming it is legal to market the same
active ingredient in both a prescription and OTC product, different products may be legally sold in the
same package. Given the fine distinctions to what is or isn't the "same," the answer would appear to be
highly case specific, based on how and for what purpose a given product was being marketed. In some of
the examples provided earlier, the manufacturer and FDA evidently reached a judgment that different
packages were appropriate to distinguish otherwise more closely similar products form one another.
Clotrimazole and some of the H2s are examples of this. While both of the original minoxidil 2 percent
versions were OTC, they were in different packages. In contrast, in the professional information
examples, including explicit dosage instructions based on the age of a child, different packages were not
the end result.
<12: 8.8, 9.1.1>B. While not entirely clear as a broad rule, there are circumstances were it would be
inappropriate to sell to marketed products, one Rx and one OTC, in a single package. Finally, FDA asks,
if two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so? As with the previous questions, given the fine distinctions that are sometimes
drawn, the answer would appear to be highly case specific. Factors FDA and a manufacturer might
consider in answering a case-specific question could include reducing consumer confusion, assuring data
exclusivity protections are accounted for, or ease of use, among others. In both the simultaneous
prescription and OTC realm, and the OTC realm, there are any number of examples where distinctions in
indications, dosage forms, or strengths have led to separate packages, which in turn reduces the chances
of consumer confusion, addresses data exclusivity rights, or eases use. Antifungals (dosage form
distinctions, indication distinctions, and/or strength distinctions); an ingredient which can be either an
antihistamine or a sleep aid (indication and strength distinctions); minoxidil (gender and strength
distinctions); and analgesics (strength and/or indication distinctions) are examples with separate
packages.
Conclusion.
<13: 3.8.4>While the same drug, at the same dosage form and strength, and for the same indication,
cannot simultaneously be available on a prescription and nonprescription basis, FDA has long needed to
draw fine distinctions among dosage forms, strengths, methods of administration, indications or uses, or
on other bases to distinguish between OTC and prescription versions of the same active ingredient, or
between OTC labels and professional information/labeling for the same active ingredient.
In other areas apart from this ANPR, FDA in some instances has established rules to help guide both
interested parties and the agency in walking the line between various distinctions on what is or isn't the
same and what triggers different treatment, but there is no mandate to do so. In the case of the instant
question of prescription and OTC status, there are ample precedents to give interested parties paths to
follow to distinguish among different labeling requirements, leading to an active ingredient in more than
one setting not being the "same," even if an outside observer less familiar with the nuances involved
would not immediately see the distinctions.
Given the existing precedents, we see no need for the agency to initiate a rulemaking to codify its
interpretation regarding when an active ingredient can be simultaneously marketed in a prescription and
OTC drug product.
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Respectfully submitted,
David C. Spangler
Vice President - International & Assistant General Counsel
COMMENT NUMBER - 2005N-0345-C414
2005N-0345-C414 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned
Women for America, et al.
2005N-0345-C414 - TEXT
November 1, 2005
Via Hand Delivery
Division of Dockets Management
U.S. Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Comment to Docket No. 2005N-0345; RIN 0910-AF72 Circumstances Under Which an Active
Ingredient May Be Simultaneously Marketed in Both a Prescription, Drug Product and an Over-the-
Counter Drug Product
To Whom it May Concern:
Kirkpatrick & Lockhart Nicholson Graham (K&LNG) submits these Comments to Docket No. 2005N-
0345 on behalf of four groups that oppose the dual marketing of the same drug product in both the
prescription (Rx) and over-the-counter (OTC) markets. For the legal, medical, and public health reasons
set forth below, Concerned Women for America (CWA), the Family Research Council (FRC), the
Christian Medical and Dental Associations (CMDA), and the American Association of Pro-Life
Obstetricians and Gynecologists (AAPLOG) oppose the simultaneous marketing of an active ingredient
in both an Rx drug product and an OTC drug product. The groups also oppose the Rx-to-OTC switch of
Plan B (levonorgestrel) tablets, 0.75 mg, an emergency contraceptive (EC) drug product, also referred to
as the "morning after" pill (MAP).
CWA, FRC, CMDA and AAPLOG are non-profit organizations that share a great concern about women's
health issues in general, and safe contraception use in particular. CWA represents a membership of
500,000 women in 50 states across the USA. CWA seeks to represent women before Congress and U.S.
and International governmental bodies on issues of specific interest to women, including the sanctity of
human life from conception until natural death. CWA has been active in contraception-related issues for
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over 25 years. FRC is a non-profit organization formed in the 1980's that formulates public policy
recommendations that value human life. CMDA is a professional organization with thousands of
physician members representing every medical specialty. AAPLOG is a recognized interest group of the
American College of Obstetricians and Gynecologists, currently representing over 2,000 physicians
throughout the USA.
BACKGROUND
On September 1, 2005, the U.S. Food and Drug Administration (FDA) published an Advance Notice of
Proposed Rulemaking requesting public comment on whether, under the Federal Food, Drug, and
Cosmetic Act (FDC Act), an active ingredient may be simultaneously marketed inboth an Rx and OTC
drug product. See 70 Fed. Reg. 52,050 (2005). FDA presented three questions, which we answer briefly
as follows:
(1) Should FDA initiate a rulemaking to codify its interpretation of when simultaneous marketing is
permitted under the law? Yes.
(2) Would FDA be able to enforce an age-related limitation for Rx vs. OTC sales? No.
(3) May the same drug be sold in the same packaging to both the Rx and OTC markets? No.
In these Comments, we provide detailed legal, medical and public-health-protection analyses to support
the brief answers set forth above. We make particular note that in a related action, FDA denied approval
to a New Drug Application (NDA) Supplement for Plan B (levonorgestrel) tablets, 0.75 mg, in which the
Sponsor requested a switch from Rx-only status to OTC status for women ages 16 years and older.
Women under age 16 would have prescription-only access to Plan B. The undersigned support FDA's
denial of the NDA Supplement, and we provide evidence herein that this EC product should not be made
available OTC to any age group, primarily because physician involvement is paramount to the safe use of
the product.
DISCUSSION
<1: 3.3>I. FDA Lacks The Statutory Authority To Permit The Simultaneous Dual Marketing Of The
Same Drug As An Rx And An OTC Product
FDA lacks legal authority under the FDC Act, as amended by the Durham-Humphrey Amendments
(Public Law 82-215, 65 Stat. 648), to allow the dual marketing of an active ingredient simultaneously in
an Rx drug product and an OTC drug product. The statutory language, the legislative history, the
implementing regulations, and the Agency's past interpretations all preclude such dual marketing of au
active ingredient.
A. Dual Marketing Runs Counter to the Statutory, Language and Congressional Intent
The FDC Act defines a prescription drug as a drug which ""because of its toxicity or other potentiality for
harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use
except under the supervision of a practitioner licensed by law to administer such drug." 21 U.S.C.
$353(b)(1)(A). The concern is the safety of the drug product, and drug products that are not safe to use
except under the supervision of a licensed physician are to be dispensed by prescription only.
<2: 3.2, 3.3.2, 3.6.2>The legislative history of the Durham-Humphrey Amendments, as recorded in
Senate Report No. 946, notes that the "not safe" language in the statute is intended to have its ordinary
meaning. See 1951 U.S.C.C.A.N. 2,454 at 2,457 and 2,461. If the Agency has determined that a certain
drug product is "not safe" for use except under the supervision of a licensed physician, then carving out a
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subpopulation (by age, for example) would run counter to this "ordinary meaning" -not safe is not safe,
regardless of age. Drugs would not be safe for self-medication if "their unsupervised use may indirectly
cause injury," as in the case of drug products that contain potent steroid hormones which affect many
organ systems. 1951 U.S.C.C.A.N. 2,454, 2,457. See also 35 Fed. Reg. 9,001 (June 11, 1970). In fact,
courts have historically noted the safety risks particular to oral contraceptive prescription drug products.
Cf. Turner v. Edwards, 1969-l 974 FDLI Jud. Rec. 471,472 (D.D.C. 1970) (stating that "oral
contraceptives are prescription drugs, and therefore subject to different requirements as to their use and
dispensation than over-the- counter products").
We further note that the legislative history supports the broad applicability of classifying a drug as an Rx
product due to the concerns of safety for such drug products. In addressing the concerns in relation to the
Durham-Humphrey Amendments, our legislatures made clear that "the broad language of the definition
contained in [these provisions] is intended to comprehend all drugs that in fact should be administered
under medical supervision in order to insure [sic] their safe use." 1951 U.S.C.C.A.N. 2,454, 2,462
(emphasis added). This Congressional intent on making the definition of a prescription drug apply as
broadly as possible is precisely why the statutory language makes sweeping reference to "toxicity or other
potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use."
See 21 U.S.C. § 353(b)(l)(A). Allowing the marketing of a drug product as OTC based solely on the age
of a subpopulation would run counter to the Congressional intent of drafting the statutory language in this
broad way.
<3: 6.5.2>Indeed, the language of the statutory definition for a prescription drug "clearly shows that
toxicity is only one fact to be considered" in determining whether a particular drug is safe for use without
medical supervision. 1951 U.S.C.CA.N, 2,454, 2,457, Given the overarching purpose of the FDC Act to
protect the public health, the breadth of this statutory definition serves to "effectively restrict to
prescription sale all drugs that require professional supervision for their use." 1951 U.S.C.C.A.N. 2,454,
2,457 (emphasis added).
Thus, the concerns for safety, as well as the breadth of the statutory language, indicate that Congress
intended the reach of the definition of a "'prescription drug" to be as wide as possible. To carve out an
OTC exception for a drug product currently approved for prescription use would run counter to this
legislative intent set forth in the Congressional record for the Durham-Humphrey Amendments.
<4: 3.3.2>B. Dual Marketing Runs Counter to the Dichotomous Classification of Drug Products
A plain-meaning interpretation of the statutory language indicates that the Agency may not allow the dual
marketing of a drug as both Rx and OTC. The statute states that FDA may "remove drugs.. .from the
requirements of [21 U.S.C. § 353(b)(1)] when such requirements are not necessary for the protection of
the public health." 21 U.S.C. § 353(b)(3) (emphasis added). The statutory language allows for the Agency
to "remove drugs" from one classification (Rx) and into another (OTC). The statutory language, in
essence, provides for requisite conditions to market a drug as an OTC drug product by noting
inapplicability as an Rx product. Cf. 70 Fed. Reg. 52,050 at 52,051 (stating that the term "OTC drug" has
been adopted to refer to any drug that does not meet the definition of a prescription drug in 2l U.S.C. §
353(b)(l)). Thus, a dichotomy exists between the prescription and OTC drug "classification." See id.; see
also 21 C.F.R. § 310.200 (describing FDA's prescription exemption procedure).
If one "removes" a drug from regulation as an Rx drug, then that drug becomes an OTC drug. One cannot
"remove" a drug from the prescription classification and still regulate that drug product as an Rx drug.
Either the drug is "removed" from the prescription drug regulatory rubric and is therefore an OTC drug,
or the drug remains under the Rx rubric and is not an OTC drug. The mutually exclusive nature of the
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dichotomous classification of a drug product as either Rx or OTC is manifest in the statutory language.
Cf. 21 U.S.C. 353(b)(4). The dual marketing of the same drug as Rx and OTC therefore runs contrary to
the plain-language meaning of the statute.
<5: 3.3.2, 8.5.1>C. Dual Marketing Causes Confusion Between Drug Products
The underlying concern both for FDA and Congress in the statutorily-required dichotomous classification
is the potential. for confusion that would arise if the statute did not provide for this bifurcation between
Rx and OTC drugs. .See e.g., 21 U.S.C. §§ 353(b)(4)(A) and (B) (stating, in essence, that a prescription
drug must have the "Rx" symbol on its label, whereas an OTC drug must not have this symbol on its
label, to avoid the potential for confusion). In fact, courts have noted historically that if birth control pills
were extensively disseminated outside distribution channels for prescription drug products, different
standards of labeling might be applicable. See, e.g., Turner v. Edwards, 1969-1974 FDLI Jud. Rec. 493,
494 (D.D.C. 1971).
Likewise, the legislative history of the statutory language at hand underscores the concern for labeling
confusion by stating:
. . . the interstate label on [prescriptions drugs must bear the statement "Caution: Federal law prohibits
dispensing without prescription." On the other hand, over-the-counter drugs are forbidden to bear a label
containing this caution statement. A prescription drug, the label on which does not bear the specified
caution statement, is deemed to be misbranded. So, too, is an over- the-counter drug, the label on which
bears this or a substantially similar statement.
See 1951 U.S.C.C.A.N. 2,454, 2,463. Cf. 1951 U.S.C.C.A.N. 2,454, 2457 (stating that the statutory
definition of a prescription drug "could bring an end to the existing confusion in drug labeling and that
uniformity can be achieved"). See also 70 Fed. Reg. at 52,051 (noting the resulting confusion and
uncertainty that arose due to a lack of criteria in determining when to limit a drug product's approval to
prescription use).
<6: 4.4.1>The dual marketing of an active ingredient both as an Rx drug and as an OTC drug would only
exacerbate this previously-identified confusion, especially if the product was sold in the same package to
both markets, or differed only in age-limited dispensing. In order to avoid this confusion, the statutory
provisions of the FDC Act prohibit the marketing of the same drug product in an identical package in
both the Rx and OTC markets. Instead the law requires, at the very least, labeling with or without the "Rx
" symbol. Thus, the inclusion (or exclusion) of the "Rx" symbol on a label would preclude the marketing
of a drug product in that package for both the Rx and the OTC markets. Likewise, the FDA's labeling
requirements differ substantially for the Rx and OTC markets, such that the labels on the packages could
not be the same. See 21 C.F.R. Part 201, subpart B (Rx labeling) and Subpart C (OTC labeling).
<7: 7.5.3>Moreover, even if a firm attempted to market two different packages, with one package
including the "Rx" symbol and the other excluding this symbol, the administrative task of ensuring this
dual marketing would be burdensome at best, infeasible at worst. During the approval process, the
Agency would need to pass judgment on the Sponsor's plans for utilizing both marketing avenues for the
product. During post-approval marketing, the Agency would have to expend its limited resources to
ensure that, among other tasks; (I) the manufacturer printed two labels with information appropriate to the
distinct markets (i.e., health care providers or consumers), (2) the distributor shipped the packages to the
correct retailer, and (3) the pharmacist stocked the relevant shelves with the correct package and
dispensed it properly. This extensive regulation of the dual marketed product would be antithetical to the
purposes of the FDC Act, which sought precisely to eliminate this type of confusion through the
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definition of a prescription drug.
<8: 8.5.1>D. FDA Regulations Demonstrate the Separation of Rx and OTC Marketing Avenues
The regulatory provisions governing oral contraceptives further demonstrate the difficulty that the
Agency would face in allowing the dual marketing of an active ingredient both as an Rx drug and as an
OTC drug. The regulations stipulate that "the safe and effective use of oral contraceptive drug products
requires that patients be fully informed of the benefits and the risks involved in their use." 21 C.F.R. §
310.501(a). Furthermore, the requirements for the requisite patient package inserts for oral contraceptives
are both extensive in reach and exhaustive in content. See 21 C.F.R. § 310.501 (noting the wide-ranging
requirements for oral contraceptive patient package inserts).
In contrast, the Drug Facts Panel of an OTC drug product is intended to be comprehended by the
layperson without need for medical supervision. By allowing the dual marketing of an active ingredient
both as an Rx drug and as an OTC drug, the Agency would be conflating the concerns of safety
underlying a prescription package insert with the purposes of simplicity underlying an OTC drug label.
Such a decision by the Agency would only add to the confusion that the statutory language and legislative
history of the FFDCA precisely sought to avoid.
<9: 8.5.1>This dichotomy between Rx and OTC drug products is made clear by the fact that FDA has
numerous implementing regulations specific to Rx drug products, as well as regulations specific to OTC
drug products.
For example, FDA regulates Rx labeling in 21 C.F.R. §§ 201.50-201.59, whereas FDA regulates OTC
labeling in 21 C.F.R. §§ 201.60-201.72. Furthermore, under the labeling provisions, with regard to
exemptions from adequate directions for use, 2l C.F.R. §§ 201.100 and 201.120 are specific to Rx drug-
products. In addition, for specific labeling requirements for specific drug products, FDA again makes this
distinction between Rx and OTC drug products. See 21 C.F.R. §§ 201.300-201.323.
<10: 8.5.1>FDA further delineates the distinction between Rx and OTC drug products by limiting to Rx
drugs the Agency's regulations as to advertising (21 C.F.R. § 202), as well as its regulations as to
marketing restrictions (21 C.F.R. § 203). Furthermore, FDA regulations as to the guidelines for state
licensing of wholesale drug distributors are limited to Rx drugs. See 21 C.F.R. § 205. In addition, the
medication guide regulations in 21 C.F.R. § 208 are limited to Rx drug products.
The Agency implements the Rx-exemption procedures, as well-as the exemption for certain drugs limited
by NDAs to Rx sale, through its regulations in 21 C.F.R. § 310.200 and 21 C.F.R. § 310.201,
respectively.
In addition, FDA's requirement for specific new drugs in 21 C.F.R. §§ 310.501-310.518 are for Rx,
whereas the requirements for specific new drugs in 21 C.F.R. §§ 310.519-310.548 are for OTC. Likewise,
the FDA regulations in 21 C.F.R. §§ 328-358 are limited to OTC monographs. In contrast, 21 C.F.R. §
361 is limited to Rx drugs used in research. Yet the regulations in 21 C.F.R. § 369 pertain to interpretative
statements regarding warnings on OTC drugs. This regulatory separation supports the statutory
dichotomy of Rx and OTC drug products.
<11: 3.3.2, 6.5.1>E. Past Agency Position Precludes Dual Marketing Without Meaningful Difference
According to FDA's present regulatory interpretation of the Durham-Humphrey Amendments, the
marketing of the same active ingredient in different drug products in both the Rx and OTC markets
assumes some meaningful difference exists between the two marketed drug products. See, e.g., 70 Fed.
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Reg. at 52,051 (emphasis added). Historically; FDA has concluded that the meaningful difference relates
to five parameters - the product's active ingredient, indication, strength, route of administration, or dosage
form. See id. Even so, however, FDA has been reticent to acknowledge a "meaningful difference" in a
drug product, determining instead that physician supervision is still necessary when a drug product's
strength or dosage form, for instance, is distinct. Only in a few cases in the past 50 years has FDA
determined that a change in one of the five drug product parameters provided enough of a difference to.
support the safe use of the product without physician supervision, See 70 Fed. Reg. 52,050 (citing
specific product differences in indication, dosage form, and strength). And most of those cases involved
two separate indications, for which one of the indications a layperson could clearly self- diagnose and
self-treat, but the other indication required a physician diagnosis and supervision (e.g., prescription for
ulcers vs. OTC for heartburn). In other words, only rarely can a drug product with one parameter (e.g.,
lower strength) be used safely without physician supervision, when that physician supervision is required
for the safe use of the product with a different parameter (e.g., higher strength).
<12: 6.5.2>Furthermore, there is no legal support for an FDA conclusion that a difference in a
subpopulation, related to age, constitutes the type of "meaningful. Difference" that would negate the
concerns of safety associated with a drug product that is marketed as prescription drug and, thus, support
dual marketing. A distinction by age subpopulation does not alleviate the safety concerns associated with
the drug product's "toxicity or other potentiality for harmful effect"; if a drug product is not safe for use
by one age group except under the supervision of a licensed physician, those same safety concerns, apply
to all subpopulations, regardless of age. In sum, the dual marketing of a drug product as prescription-only
for one age group and OTC for another age group represents an arbitrary agency action without legal
support.
<13: 6.5.2>II. FDA Lacks The Statutory Authority To Create A Pharmacist-Dispensed "Behind The
Counter" Class or "Third Class" Of Drugs
A. A Third Class of Drugs Runs Counter to the Durham-Humphrey Amendments
By considering the dual Rx and OTC marketing of Plan B based on an age limitation, FDA is necessarily
contemplating the creation of a third class of drugs intended for sale "behind-the-counter" (BTC) by
pharmacists. This third class would be inevitable because the product's labeling would have an age-related
limitation for OTC sale (i.e., 17 years and above), In all likelihood, then, pharmacists would need to
control access to the drug to enforce the age limitation.
FDA itself does not have, the authority to ensure that-this age limitation. is enforced. Furthermore, the
creation of a "third class" of drugs beyond the Rx and OTC markets is unlawful without legislative
changes to the FDC Act because, as discussed above, the distribution of medicine in the United States is
based on a two-class system - prescription and OTC - that was formalized by Congress in 195.l. The goals
of the prescription-nonprescription distinction were to protect the public from abuses in the sale of potent
prescription, drugs, and to relieve pharmacists and the public from burdensome and unnecessary
restrictions on the dispensing of safe OTC medicines. This law directed FDA to distinguish between
drugs that were too dangerous for use without professional supervision and those that were safe on an
OTC basis with adequate directions and warnings on the label. The statute provides no authority for FDA
to establish a new class, i.e., a third class of drugs - whether because the labeling needs to be
supplemented by a pharmacist's instructions, or because a certain subpopulation might misuse the drug
with direct access. [Footnote 1: Some have suggested that Plan B's proposed age distinction- is no
different from age restrictions for alcohol or tobacco sales. These proponents of the age distinction
assume incorrectly that enforcement of the age restrictions for the sale of alcohol and tobacco is
successful. In 1998, underage buyers were able to buy alcohol in 97% of purchase attempts in
Washington, DC, 82% of attempts in Westchester County, NY, 44% attempts in Schenectady, NY, and
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59% of attempts in northwestern New Jersey. See Preusser, D.F., and A.F. Williams, Sales of alcohol to
underage to underage purchasers in three New York counties and Washington D.C., Journal of Public
Health Policy 13(3):306-317 (1992). For every 100,000 occasions of youth drinking, only 5 alcohol
outlets incur actions by a state Alcohol Beverage Control Agency. See Wagenaar, A.C., and M. Wolfson,
Enforcement of the legal minimum drinking age in the United States, Journal of Public Health Policy
15(1):37-58 (1994}. Certain state police forces have instituted effective compliance cheek programs;
however, successful enforcement of the minimum drinking age requires the enactment of laws prohibiting
such action, implementing regulations that prevent adults from buying, alcohol for minors and enclosing
areas for alcohol sales and consumption to make it more difficult for adults to pass alcohol to minors. The
framework for enforcement of tobacco and alcohol age restrictions may be theoretically present, but the
reality is, enforcement is difficult and often not realized. In addition since there is no statutory
enforcement provision in the context of age limits for approved drugs, the framework cannot be easily
translated to a BTC drug class.] <14: 6.5.3> Moreover, at least one court has questioned
FDA's authority in this area. In APhA V. Weinberger, the Court held that FDA lacked statutory authority
to impose or authorize the imposition of certain post-approval controls on methadone and declared the
regulations invalid to the extent that they prohibited or restricted shipment to, or receipt or dispensing by,
a duly- licensed pharmacy. [Footnote 2: APhA v. Weinberger, 377 F. Supp. 824 (D.D.C. 1974).]
Similarly, the U.S. Justice Department and the National Association of Attorneys General have opposed a
third class of drugs, calling such proposals anti-competitive and anti-consumer because they create a
monopoly in the distribution on nonprescription drugs. [Footnote 3 Consumer Healthcare Products
Association (CHPA) comment to FDA, Docket No. 00N-1256; Over-the-Counter Drug Products, August
25, 2000, p. 19, footnote l6.]
<15: 7.5.1, 7.5.2>B. FDA Does Not Have The Authority or the Resources To Enforce An Age
Restriction for the Same Drug to be Marketed as Rx and OTC
Because FDA does not have the statutory authority or thee economic or personnel resources to enforce an
age restriction for Plan B sales, enforcement activities would fall to the states, local governments, or
pharmacies. Yet, FDA has ho regulations to instruct third parties in appropriate enforcement activities,
nor is there any mechanism for FDA to ensure that enforcement is carried out.
<16: 6.6.1>Some states have shown a willingness to create a framework for BTC drugs. Alaska,
California, Hawaii, Maine, New Mexico, and Washington currently offer emergency contraception
behind the counter. However, other states, such as Louisiana, are unable or unwilling to expend the
financial resources necessary to promulgate pharmacy access laws and enforce the regulation's
restrictions. This uneven regional enforcement illustrates the imprudent and illegal nature of a dual
marketing approval for Plan B. It is also unclear that FDA has the requisite legal authority to supervise
and correct the states' efforts, or lack thereof.
<17: 6.6.1>Furthermore, previous attempts to restrict consumer access to nonprescription substances have
effectively failed. Some states restrict consumer access to-Schedule V (e.g., cough medicines with
codeine) nonprescription controlled substances to pharmacist-only sales. These restrictions were imposed
under state controlled substance laws, not federal law. The original intent of the restrictions was to
prevent abuse, but many states that originally placed Schedule V nonprescription drugs behind the
counter realized that the restrictions did not achieve their intended purpose. As a result, roughly half of
the states placed these nonprescription drugs on prescription status under the states' controlled substance
laws. [Footnote 4: Among others, these include California, Colorado, Louisiana, Montana, Nebraska,
New Hampshire, North Dakota, Oregon, Rhode Island, and Texas, See-R. William Soller, Eve E
Bachrach, Doc. No. 00N-1256: Over-The-Counter (OTC) -Drug Products: Request for Comments; 65
Fed. Reg. 24704, April 27,2000 (August 25, 2000), available at www.chpa-
info.org/web/advocacy/submissions/08_25_00_OTC~commets.pdf.]
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<18: 6.6.1>Some proponents of a third class of drugs have offered-as precedent certain restrictive drug
distribution models in the United States. Upon closer examination, however, these examples do not
provide a basis for pharmacist-only third class distribution of nonprescription drugs. For example, the
state of Florida initiated an experiment in 1985 under the Pharmacist Self-Care Consultant Law to permit
pharmacists to prescribe a limited number of prescription drugs without physician supervision. The GAO
Report described below, found that the authority was rarely used because pharmacists and/or pharmacies
were unwilling to assume the liability risks. [Footnote 5: See Nonprescription Drugs: Value of a
Pharmacist-Controlled Class Has Yet to Be Determined, Report GAO/PEMD-95-12. Washington, DC.:
U.S. General Accounting Office, Program Evaluation and Methodology Division, August 1995 at 57-59,
65, 79 [hereinafter, GAO Report]. ]When the prescribing authority was used, the law's record-keeping
requirements were seldom followed because pharmacists were already burdened, by time pressures to
address other responsibilities. Given that there is currently a shortage of pharmacists, the time-pressures
that a pharmacy-only class of nonprescription drugs would add make such a plan even less appealing.
<19: 7.5.3>C. From Both Practical and Public Policy Standpoints, the Health Care System in the US.
Does Not Support a Third Class of Drugs
In addition to the legal impediments, the U.S. health care system as a practical matter does not have the
necessary infrastructure to support a BTC class of drugs. With respect to pharmacy practice, pharmacists
in the U.S. and elsewhere often do not perform the roles on which the benefits of the third class are
premised, even when such roles are expected or required. Pharmacists are expected, among other things,
to provide complete counseling, report adverse drug events, and maintain patient profiles, but often do
not. [Footnote 6: See GAO Report at 28. ]
A third class of BTC drugs in the U.S. will necessitate the active participation of pharmacists.
Pharmacists will be forced to provide meaningful advice and counseling before, offering products from
behind the counter. The education of pharmacists would have to include training on retail patient
counseling, which, for the must part, is currently lacking. Pharmacies would also have to grant their
pharmacists time away from dispensing drugs to meet with patients. The burden of this financial cost will
not be willingly absorbed by the pharmacies, and will most likely be borne by the patients themselves.
The push for BTC drugs to reduce the cost of prescription drugs may ironically result in inflation of drug
costs. At this time, there is nothing available from insurance companies or other sources for patient
reimbursement for patient drug counseling.
<20: 7.5.3>As a public policy matter, evidence of the-need for QT benefit of a third class of drugs is
lacking. In 1995, the U.S. General Accounting Office (now called the present Accountability Office)
researched other countries that use the BTC drug avenue and found that use of a pharmacy only class to
prevent abuse met -with similarly poor results in other-countries. In a study performed in Germany, for
instance, children between 10 and 14 were directed to purchase medicines containing alcohol from
pharmacies. In all 54 pharmacies visited, the children were allowed to purchase the drugs, and in only one
instance was the child questioned intensively. [Footnote 7: See GAO Report at 28. ] The GAO also
found that safeguards against abuse are easily circumvented and that actual counseling of patients by
pharmacists is infrequent and incomplete. [Footnote 8: Id.] The GAO stated specifically that other
countries' experiences "do not support a fundamental change in the drug distribution of the United States
such as creating an intermediate class of drugs . . . . The evidence that does exist tends to undermine the
contention that major benefits are being obtained in countries with a pharmacist or pharmacy only class"
[Footnote 9: Id.] Among the organizations opposing a third class of drugs are the American Medical
Association, Interamerican College of Physicians and Surgeons, National Black Caucus of State
Legislators, National League of Nursing, Food Marketing Institute, Consumer Alert, National Black
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Women's Wealth Project, National Coalition of Hispanic Health and Human Services Organizations,
National Grange, National Council on Aging, Food Industry Association Executives, and many others.
[Footnote10: See Third Class of Drugs, CHPA, available at http:/www.chpa-
info.org/web/advocacy/general_issues/third_ class.aspx .] <21: 6.5.2>Regardless of the
public policy issues associated with a BTC class of drugs, the existing dichotomy of prescription and
OTC drugs is well established in the FDC Act and any alterations would require explicit action by
Congress.
<22: 7.5.3>The existence of third class drugs in other countries does not support establishing the same in
the United States. No public health advantages have been identified to justify creating a third class of
drugs, nor to provide patients with better access to medicines. In its 1995 report to Congress, the GAO
concluded that "the existence of a third class does not make regulatory officials more or less likely to
approve new OTC products or switch prescription drugs to unrestricted nonprescription status."
[Footnote 11: See GAO Report at 42-43, 78.]
<23: 3.8.3, 6.6.2, 7.5.3>D. Without A Third Class of Drugs, OTC Sale Is Unregulated and Uncontrolled
Whether Congress creates a third class, or FDA by regulation creates a third class, without such a creation
the Plan B product will be freely available to all consumers. Presently in the U.S., an OTC drug can be
sold anywhere to any consumer unless restricted by state law. Thus, if FDA approves Plan B for OTC
sale and a state does not restrict the sale to pharmacies, the drug would be available at any gas station, 7-
11, or other business that wanted to sell the drug. In such a setting, does anyone believe the under-17 age
limit will be observed, much less enforceable? [Footnote 12: For the remainder of these Comments, we
will refer to the proposed age restriction for Plan B OTC sales as 17-and-over and under-l 7, as delineated
by FDA, though we acknowledge that the Sponsor's NDA Supplement requested a restriction at age 16.
See Not Approvable Letter, Lester M. Crawford, DVM, Ph.D., Commissioner, FDA, to Duramed
Research, Inc. (Aug. 26, 2005). ] FDA has been given the statutory tools to protect the public health for
the nation, and the switch of Plan B without a regulatory framework to control the drug's use in under-age
children is without precedent. It may be that some statutory plan can he created to provide this drug OTC
to adults, but the current statutes and regulatory scheme do not provide them. Moreover, FDA should not
usurp the role of Congress by creating a marketing exception to the laws and regulations currently on the
books.
<24: 3.1>III. FDA Must Initiate And Complete Full Rulemaking Proceedings In Order To Institute The
Simultaneous Dual Marketing Of The Same Rx/OTC Drug Product
FDA has asked whether it should proceed with notice and comment rulemaking to codify the FDA's
interpretation of Section 503(b) as to when a drug can be dually marketed as OTC and by prescription,
since FDA historically has not allowed marketing of the same active ingredient in a prescription for one
population and OTC for another. The brief answer is yes.
<25: 3.4>Agency "rules" are broadly defined in Section 551 of the Administrative Procedures Act (APA)
as the whole or a part of an agency statement of general or particular applicability and future effect
designed tri implement, interpret, or prescribe law & policy, or describing the organization, procedure, or
practice requirements of an agency Agency rules include the approval or prescription for the future of
rates, wages, corporate or financial structures or reorganizations thereof, prices, facilities, appliances,
services or allowances therefor or of valuations, costs, or accounting, or practices bearing on any of the
foregoing. [Footnote 13: See 5 U.S.C. § 551. ] Given the magnitude of the regulatory change that FDA
would be enacting, despite the Durham-Humphrey Amendments, any FDA approval of an active
ingredient for simultaneous Rx and OTC marketing is a new Agency "rule" that triggers notice and
comment rulemaking.
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In order to issue a rule, an agency must complete a three step process - issuance of a notice of proposed
rulemaking, receipt and consideration of comments on the proposed rule, and issuance of a final rule
incorporating a statement of its basis and purpose. Section 553(b)(A) of the APA exempts several types
of rules from the rulemaking process. The exemptions cover interpretative rules, general statements of
policy, procedural rules, rules the agency has "good cause" to issue without the rulemaking process, and
rules that apply to particular subject matters -e.g. military or foreign affairs, However, none of these apply
to the Plan B dual marketing.
<26: 3.6.1>In particular, if the Agency issues a general statement of policy, it need not go through notice
and comment. However, the task of distinguishing between a rule and a general statement of policy is
complicated by the reality that many rules are also general statements of policy. To determine what
procedures an agency must use, courts distinguish between rules and policy statements based on whether
the agency statement has binding effect on members of the public. Thus, if a general statement of policy
binds the public, the agency must issue the statement using notice and comment procedures. See Pacific
Gas and Electric v. FERC , 506 F.2d 33 (D.C. Cir. 1974). The issue of simultaneous marketing would
bind the public in the case of Plan B, as well as establish Agency precedent for future Rx-to-OTC switch
decisions. Consequently, the issue is not merely a general statement of policy.
An additional exemption to the notice and comment procedures is issuance of an interpretative rule. A
majority of the Circuits, the DC Circuit included, utilize the following factors to determine when an
agency action is legislative, requiring notice and comment, or interpretative, which is exempt from notice
and comment: (1) whether in the absence of the rule, there would not be a basis for enforcement action,
(2) whether the legislative rule claimed to be interpretative is too vague or open ended to support the
interpretive rule, (3) whether the agency has explicitly invoked its general legislative authority, or (4)
whether the rule effectively amends a prior legislative rule. See Health Insurance Association v. Shalala,
23.F.3d 412 (D.C. Cir. 1994) and ANR Pipeline v. FERC, 205 F.3d 403 (D.C. Cir. 2000) Interpretive
rules which do not require notice and comment are those which merely clarify or explain existing law or
regulations. Malone v. BIA, 38 F.3d 433 (9th Cir. 1994). As argued above, simultaneous dual marketing
presents a new and about-face interpretation of the FDC Act, not a mere clarification.
Any claim of exemption from the rulemaking requirements of the APA will be narrowly construed.
Further, when rules to be adopted by an agency will have a broad impact not merely on the regulated
industry but also on the general public in a matter which concerns the public and transcends economic
issues, the notice requirements of the APA must be interpreted liberally. See NRDC V. SEC, 389 F. Supp.
689 (D.D.C , l974). Also, when an agency statement effects a change in existing law or policy, it will be
considered a substantive rule requiring notice and comment even if the agency labels the action as
interpretative. D&W Food v. Block, 786 F.2d 751 (6th Cir. 1986): Similarly, if a rule constitutes a
change in prior agency position and has a substantial impact on the rights and obligations of members of
then public, the rule is invalid if there has not been compliance with notice and comment procedures.
NRTA v. USPS, 430 F. Supp 141 (D.D.C. 1977), affirmed 593 F.2d 1360. See also Benten v. Kessler,
799 F. Supp. 281 (E.D.N.Y. 1992). Notice and comment rulemaking is required before FDA can approve
an NDA Supplement that would produce the kind of sea-change presented by simultaneous dual
marketing of an Rx and OTC drug product.
<27: 3.7.1, 8.5.4>With regard to the matter at hand, we question whether the current Rx labeling for Plan
B can be simplified to the extent necessary to present information in the OTC-required Drug Facts Format
(21 CFR § 201.66), while also adequately warning patients of risks, side effects, and contraindications.
For example, the labeling of human prescription drugs requires not only a summary of the essential
scientific information needed for the safe and effective use of the drug, but also specific information
required under 21 CFR § 201.57 including clinical pharmacology, and detailed contraindications, drug
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interactions' and warnings. This information on prescription labeling consists of concise, yet still dense
paragraphs of detailed drug information.
In contrast, during the rulemaking process for OTC drug labeling, FDA cited literature studies confirming
that OTC drug product labeling requires short statements and clear graphical features and visual cues to
ensure readability and comprehension. See 64 Fed. Reg. 13254 (March 17, 1999). These and other studies
described the importance of adherence to directions for use, and reported on a number of preventable
adverse drug reactions from OTC drug products with confusing labeling. Id., Accordingly, for certain
drugs it is not possible to convey the amount of information needed to adequately inform consumers of
the required directions for use and safety information using the simplified OTC labeling requirements.
[Footnote l4: In the proposed rule making for CDTC labeling, the FDA stated "information. . .presented
in a paragraph format . . . is unappealing to the eyes and may cause the-reader to lose interest." 62 Fed.
Reg. 9,024, 9,028. (February 27,1997).] Plan B is such a drug.
<28: 3.7.1>Moreover, FDA promulgated a regulation acknowledging safe and effective use of
contraceptives requires that patients be fully informed of the benefits and risks involved in their use. See
21 CFR § 310.501. To provide full information a patient package insert must be distributed. Id. That
package insert must include a number of warnings including: information on medical conditions that are
not contraindications to use but deserve special consideration in connection with oral contraceptive use
and about which the patient should inform the prescriber; a warning regarding the most serious side
effects of oral contraceptives; a statement of other serious adverse reactions and potential safety hazards
that may result from the use of an oral contraceptive; a statement concerning common, but less serious
side effects which may help the patient evaluate the benefits and risks from the use of an oral
contraceptive; as well as eight additional areas of information. Id.
These two rulemakings are in direct conflict with each other in the case of the Plan B oral contraceptive
product. We assert that the conflict may only be resolved by FDA adherence to the most comprehensive
set of labeling - the patient package insert which, in turn, requires physician interpretation and
prescription-only sale. <29: 3.4>Nevertheless, even in the alternative, it is clear that FDA
cannot approve OTC labeling in the Drug Facts Format for Plan B without complying with APA notice
and comment rulemaking to fully examine this regulatory conflict. Thus, FDA must initiate and complete
full rulemaking proceedings in order to institute the simultaneous dual marketing of the same drug
product as Rx and OTC.
<30: 1.2.3>IV. The FDA Approval Of An NDA Supplement Permitting The Simultaneous Dual
Marketing Of Plan B (Levonorgestrel) Tablets As An Rx And An OTC Product Would Be Arbitrary,
Capricious, And Unlawful Agency Action
A. The Safety Profile and Method of Use of Plan B Requires the Supervision of a Physician and, Thus,
an Rx Classification
As explained above, the FDC Act, FDA regulations, and Agency precedent all dictate that, in order for a
drug to be approved for an OTC switch, it must be proven safe and effective for use by the lay public
without the involvement of a physician. For Plan B, however, physician supervision is paramount to the
safe use of the drug, for physical, emotional, and societal reasons. According to the drug's approved
labeling, Plan B is used "to prevent pregnancy after known or suspected contraceptive failure or
unprotected intercourse", and not for routine birth control. Consequently, its proper method of use
involves a certain degree of knowledge of birth. control options, failure rates of those options, and female
biological cycles. To our knowledge, the Sponsor has provided no data on a woman's age-related or
maturity-related ability to assess these items and appropriately choose Plan B as her contraception option
without physician involvement. A physician/patient conversation on the proper use, risks, warnings, and
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range of birth control and emergency contraceptives, no matter how brief is beneficial for women's
health.
<31: 1.2.3>1. The FDA Lacks Proof that Plan B is. Safe and Effective for OTC Use By Patients Ages 17
Years and Older
Health Risks Identified In the Approved Labeling of Plan B
An Rx-to-OTC switch may occur only when the prescription marketing of particular drug is not necessary
for the protection of the public health. See 21 U.S.C. § 353(b)(3). Yet, the Plan B switch fails to meet this
statutory requirement. In fact, at least four health risks are inherent in Plan B use, including serious drug
interactions, increase in known risks, adverse reactions, and lack of patient compliance. These risks will
only be heightened by the drugs OTC marketing, with the likely result of increased adverse health events.
First, because Plan B interacts with other drugs and has the propensity to cause serious adverse events
from drug interactions, the public health would be jeopardized if FDA permitted its OTC marketing.
Specifically, the approved labeling warns against Plan B with nevirapine, rifampin or St. John's wart.
These therapies are used to treat HIV-l , tuberculosis, and mild to moderate depression - diseases that
affect more than 21 million people nationwide. [Footnote 15: According to the Centers for Disease
Control (CDC); at the end of 2003, an estimated 1,039,000 to 1,185,000 persons in the U.S. were living
with HIV/AIDS. See CDC National Center for HIV, STD and TB Prevention, Division of HIV/AIDS
Prevention, Basic Statistics, at http://www.cdc.gov/hiv/stats.htm. More than 14,000 cases of tuberculosis
were reported in 2003 in the United States, See CDC National Center for HIV, STD and TB Prevention,
Division of Tuberculosis Elimination, Questions and Answers About TB, 2005, at
http://www.cdc.nov/nchstp/tb/faqs/qu_introduction.htm. According to the National Institutes of Health
(NIH), depression affects nearly 19 million Americans each year. See NIH National Center for
Complementary and Alternative Medicine, St. John's Wart and the Treatment of Depression, at
http://www.nih.gov/health/stjohnswort.] The amount of women who are taking these drugs to treat these
diseases and, thus, should not take Plan B, is numerous and must be considered by FDA. Does FDA have
evidence that, without physician involvement, women in these disease categories will understand the drug
interaction risks and refrain from using Plan B? The OTC switch would remove the supervisory activity
provided routinely by physicians and pharmacists who monitor and evaluate a patient's drug profile for
drug/drug interactions. The combination of serious drug interactions with the lack of
physician/pharmacist supervision inherent in the OTC marketplace supports the necessity of prescription
dispensing to ensure the safe use of Plan B.
<32: 1.2.3>Second, without physician involvement, there is likely to be an increase in the
known/expected risks described in the approved labeling. Oral contraceptives are associated with DVT's,
ectopic pregnancies, dysplasia, liver hemangiomas, and other risks. An increase in these risks would be
caused by a lack of screening for medical contraindications. The group Alabama Physicians For Life, Inc,
(APFLI) noted in comments to FDA that in order for a patient to receive low hormone dose oral
contraceptives the patient is typically given a physical examination before receiving a prescription, while
for a high dose of hormones is supplied in Plan B, the OTC use would not require a medical
examinations, medical history, or other physician counseling. [Footnote 16: See APFLI letters to FDA
dated Sept. 20, 2004, Jan. 14, 2005, and Aug, 22, 2005, available at
http://www..physiciansforlife.org/content/view/793/36/.]
Ectopic pregnancies can lead to rupture and internal bleeding and may damage fertility. AAPLOG notes
that in World Health Organization (WHO) EC Task Force trials, the ectopic pregnancy rate for EC users
was triple the regular rate. [Footnote 17: CMO Update 35A [communication to all doctors from the Chief
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Medical Officer] January 2003; Department of Health, Published 04/02/2003. Overseas Post-marketing
Surveillance of EC use (Levonelle, reported to the Committee on Safety of Medicines from the WHO
Task Force trial) showed a reported ectopic pregnancy rate of 6%, three times the usual rate. The UK
Dept of Health even issued a warning to its doctors to be aware of this.
http://www.dh.gov.uk/PublicationsAndStatistics/LettersAndCirculars/CMOUpdate/CMOUpdateArticle/fs
/en?CONTENT_ID=4003844&chk=2uZJEX.] Another, doctor commented to CWA that it is possible that
a woman could have an ectopic pregnancy and believes that it was aborted when in fact, the pregnancy
was not terminated, only to find out that the EC did not work when the pregnancy ruptures. [Footnote
18: See Letter from, Chris Kahlenborn , MD , Oct. 24, 2005, referencing Testimony before the FDA,
December 16, 2003, re: Plan B , on file with the authors.] Schering Health Care, the makers of the
morning-after-pill in the UK, was ordered to change the wording of patient information leaflets to make
clear the potential risk of ectopic pregnancy. Does FDA have a plan to include a pre- and post-usage
pregnancy test in the packaging to prevent or identify ectopic pregnancies?.
In Australia, of the women who have remained pregnant despite taking a morning-after- pill, more than 1
in 20 have suffered an ectopic pregnancy. (Beezy Marsh, Anna Patty, Ectopic Pregnancy Linked to
Morning-After-Pill, Nationwide News Pty Lmt., The Daily Telegraph, January 31, 2003.) It is important
that women be aware of risks and to seek medical assessment if their period does not return to normal
after taking-the morning-after- pill. Ordinarily, a doctor prescribing Plan B would advise the patient-of
these risks before giving the prescription. To prevent delay in the diagnosis of ectopic pregnancy, FDA
should require a OTC Plan B label to advise women that ectopic gestation can occur with emergency
contractive pill failure. See also Nielsen, C.L., Miller L., Ectopic Gestation Following Emergency
Contraceptive Pill Administration, Contraception, 2000 November, 62(5): 275-276; Galit Sheffer-
Mimouni, et al., Ectopic Pregnancies following Emergency Levonorgestrel Contraception, Contraception,
2003. Without adequate labeling and pregnancy tests, Plan B must remain in the Rx-only category for all
age groups.
Numerous studies have shown that more research is needed to improve tolerance of progestin-only
contraceptives and identify alternative techniques that will not interfere with the endocrine events of the
cycle. Outstanding research issues include the mechanisms of endometrial bleeding, definition of
molecular and cellular targets for an endometrial approach to contraception, progesterone action,
integrins, placental protein 14, insulin growth factor binding protein- 1, and plasminogen activators.
Emergency contraception has been found to suppress progesterone-associated endometrial protein in the
midluteal uterus, potentially altering the endometrial environment unfavorably .and affecting the survival
of the early embryo, (Young, D.C., et al., Emergency Contraception Alters Progesterone-Associated
Endometrial Protein in Serum and Uterine Luminal Fluid, Obstet Gynecol, 1994 August, 84(2):226-271.)
Other hormonal treatments have noted damage to the delicate balance of reproductive hormones. A study
published in 2000 found that the Yuzpe regimen of emergency contraception reduced endometrial MUC-
1 expression, increased endometrial oestrogen receptors, lowered luteal phase serum oestrogen
concentrations, reduced endometrial thickness, and increased proportion of glandular supranuclear
vacuoles in a statistically significant way. (Raymond, E.G., Lovely, L.P., Chen-Mok, M., Seppala, M.,
Kurman, R.J., Lessey, B.A., Effect of the Yuzpe Regimen of Emergency Contraception on Markers of
Endometrial Receptivity, Hum. Reprod., 2000 Nov, 15(11): 2351-2355).
<33: 1.2.3>Third, FDA must further analyze the propensity for and severity of adverse events for Plan B,
accumulated since the Agency's Oct. 31, 2003 Office of Drug Safety Postmarketing Safety Review. The
signatories below maintain that this data supports the Rx-only sale of Plan B. Also, CWA has received
comments from an OB/GYN who works with middle school students, regarding the possible steroidal
abuse of Plan B by young athletes who believe that ingesting Plan B will help them delay epiphyseal
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closure. [Footnote 19: Physician comments are on file with the author] The Physicians Desk Reference
lists post-marketing reports demonstrating myocardial infarctions and strokes coincident with Norplant
System (75 mg levonorgestrel implant). "Plasma concentrations average approximately 0.03 ng/mL over
5 years but are very highly variable as a function of individual metabolism and body weight. Diffusion of
levonorgestrel through the wall of each capsule provides a continuous low dose of the progestin.
Resulting blood levels are substantially below those generally observed among users of combination oral
contraceptives containing the progestins norgestrel or levonorgestrel." (1999 Physicians Desk Reference,
53rd Edition, pg. 3344-3345.) The physician argues that higher doses of levonorgestrel in Plan B, if used
on a regular basis, would quite likely result in myocardial infarctions, particularly with the lipid profile of
males. Is FDA prepared to study the effects of Plan B in males and require the addition of a specific
warning before approving Plan B for OTC?
Fourth, FDA must consider, but does not have data on, the potential extent of a lack of patient compliance
with the approved labeling for Plan B in the OTC setting. The approved labeling calls for limited usage,
on an "emergency" basis, with two pills to be used per "dosage". If the product is misused in frequency or
extent, either by taking it 10 days in a row or 12 times per year or 5 pills instead of two, FDA should have
data to support the safe use of the product in these foreseeable ways. For example, Plan B is a progestin
which is linked to breast cancer and repeated use could lead to an increase in the risk of breast caner. Data
on the safety and efficacy of Plan B for long term or frequent use must be further explored before the
product is switched to the OTC market for any age group.
<34: 1.2.3>No Doctor/Patient Relationship for Addressing Complications (Physical and Emotional)
The American Academy of Pediatrics (AAP) Policy Statement on Emergency Contraception given by the
Committee on Adolescence (Ped 116: 1026-1035 (Sept. 1, 2005)) recommends that teens who receive
prescription EC via telephone receive a follow-up appointment to exclude an already existing pregnancy
and/or to deal with issues of contraception and screening for sexually transmitted diseases. The statement
also recommends doing an appropriate medical history analysis of the patient before prescribing EC. The
policy statement further recommends pregnancy testing, antibiotic prophylaxis; and counseling for rape
victims, These policies to ensure appropriate usage and adequate provision of aftercare assume a
relationship between the doctor and the patient. Although recognizing "social pressures" to make EC
more readily available, the AAP does not conclude that EC should be made available OTC. Indeed, doing
so would undermine the doctor-patient relationship that provides a safety net for the patient and ensures
that EC is used safely and effectively.
AAPLOG observes that the proposed Plan B OTC status would result in lack of physician oversight for
patients at risk of failed MAP treatment and potential ectopic pregnancy. Furthermore, patients who elect
to use MAP are generally also at high risk of getting STDs, and without physician oversight, undiagnosed
and untreated STD's lead to-infertility and cervical disease. AAPLOG maintains that use of the-MAP is
attendant with very serious long-term risks for the health of the women involved. AAPLOG insists that
physician oversight, with STD testing, pap smears, and pregnancy tests-as indicated, is essential for the
well-being of women's health, as discussed in more detail below.
<35: 1.2.3>2. The FDA Lacks Proof that Plan B is Safe and Effective for OTC Use By Patients Under 17
Years of Age
In addition to the specific safety-related and public health concerns described above - all of which would
apply to the use of Plan B in both the 17-and-over and under-17 patient subpopulations, CWA and its
physician contacts have specific concerns about the safe use of Plan B by children and adolescents under
17 years of age.
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Lack of Control with OTC Sale/Black Market to Underage Adolescents and Children
CWA has received multiple comments from doctors citing a concern over the ease with which underage
adolescents and children will be able to obtain Plan B from their older friends, boyfriends, or relatives,
based on currently insufficient age restriction mechanisms (e.g., age restriction mechanisms for cigarettes
and alcohol have little effect on preventing underage minors from obtaining cigarettes and alcohol)
[Footnote 20: Physician comments are on file with the author.] The unintended creation of a "black
market" for Plan B mitigates against an OTC bifurcation for Plan B.
<36: 1.2.3>Physical and Biological Changes in Pre-Pubescent and Early Pubescent Girls
Dr. Harold Wallis, a Texas-based OB/GYN, has observed that the MAP primarily inhibits ovulation,
disrupts follicular development, and produces pathophysiological symptoms in pre-pubescent and early
pubescent girls. [Footnote 21: Physician comments are on file with the author.] He notes that teenagers
with abnormal menstrual cycles are commonly treated for the same kind of pathophysiological problems.
Thus, without adequate age restriction enforcement to support Rx sales and physician supervision for this
subpopulation, girls in this variable "biological" age range may create the same pathophysiological
problems through the use of Plan B that necessitate common treatment by OB/GYNs.
Furthermore, this age group's general lack of understanding and experience with monthly biological
cycles and the cause pregnancy may lead to the misuse of Plan B. One study concludes that risk-taking
behavior and poor assessment of be future consequences of their actions are common characteristics of 15
- I7 year olds. (Burgis, J. and J. Bacon, Communicating with the Adolescent Gynecology Patient,
Obstetrics and Gynecology clinics of North America, 30:251-260, 2003.) Similarly, the AAP's Policy
Statement on Emergency Contraception given by the Committee on Adolescence notes; "Teens may not
be able to give sufficiently adequate menstrual histories to exclude a preexisting pregnancy, and some
teens already pregnant may try to use EC as an abortifacient." (Ped 116:1026-1035 (Sept. 1, 2005).)
<37: 1.2.3>Connection Between Plan B and STDs
APFLI noted in a letter to FDA that there has been a demonstrated link between the availability of MAP
and exposure to STDs. APFLI cited data from the Swedish Institute for Disease Control and the
Washington State Health Department demonstrating a significant increase in chlamydia infection in
women, especially teens, in the five years following OTC availability of MAP.
AAPLOG comments that in the five years following a Washington State pilot program to provide OTC
MAP, teenage women showed a 23% increase in chlamydia infections. (Sexually Transmitted Disease
Morbidity, Washington, State, Infection, Disease, and Reproductive Health, STD/TB Services & IDRH
Assessment Unit, Washington State Dept. of Health 1997, available at
http://www.doh.wa.gov.cfg.STD/mobidity.htm.) AAPLOG comments that these increases may well be
associated with the increased and unprotected sexual activity facilitated by OTC MAP. Chlamydia causes
infertility in a quarter of women and can reduce men's chances of becoming a father by 33%. As untreated
chlamydia is a major cause for infertility, the availability of MAP OTC could lead to many women,
especially teens, becoming infertile after several years of untreated and asymptomatic chlamydia.
Plan B offers no protection against STDs. In the UK where EC has been OTC for five years, figures show
that over the past four years there has been a 76% increase in chlamydia diagnoses, a 55% increase in
gonorrhea, a 54% increase in syphilis, and a 20% increase in genital warts. In all of these infections, the
highest rates and the fastest increases were found in the 16-24 age group. (The Observer, May 15,2005,
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available at http://observer.guiardian.co.uk/magazine/story/0,11931,1482669,00.html.) In Scotland, rates
of chlamydia rose by 106 percent between 1998 and 2004. Scottish Executive figures reveal almost half
of all chlamydia cases diagnosed in 2002 were in people under 25, and there has been a 66% increase in
cases involving youth under 16. A possible reason for this increase is that teenagers comforted by the idea
of a contraceptive pill use condoms less. "Too often teens think that by taking the contraceptive pill, or
ensuring their partner is taking the pill, that's all the protection they need.. .The pill can protect against
pregnancy, but it's the ever increasing numbers of nasty diseases that will do your health more long-term
harm." (Julia Hunt, Experts Fear Rise In Infertility as Chlamydia Cases Soar by 66 Percent, Scottish Daily
Record & Sunday Mail, May 2, 2004, pg. 40, 41.)
A Swedish study published in 2002 reported that STDs were on the rise among adolescents who had OTC
access to emergency contraception. and other forms of contraception. (January W. Payne, Is Plan B
Unsafe? Current Research Does Not Support Fears of Day-After Pill Dangers, September 6, 2005, Page
HE01 .) From 1999-2002, the cases of genital chlamydial infections increased between 20-28% in the
teenage population, and 14-20% among 20-25 year olds. (K. Edgardh, Adolescent Sexual Health in
Sweden, Sexually Transmitted Infections, 2002. 78:352-356.)
<38: 1.2.3>B. The Risk/Benefit Profile of Plan B is Enhanced by Physician Involvement
As discussed below, the Sponsor's label comprehension study - conducted specifically to support the OTC
switch of Plan B -reveals significant label comprehension problems with the medical information that
should be provided to patients for this drug product. A proper understanding of the risks, warnings,
contraindications, and benefits can be provided only through physician involvement in the prescribing of
Plan B. Only by marketing Plan B as a prescription product can proper patient education be undertaken.
Furthermore, physician involvement is necessary for patient counseling on the extra-label considerations
related to contraception choices in the U.S., including physical, medical, emotional, and moral questions.
Plan B should not be placed in the same category as an aspirin, a Tylenol, or an antacid. Use of Plan B
without a prescription will lead to fewer or no follow up visits with doctors, no STD testing, pap smears;
pregnancy tests and/or counseling about the effects of unprotected intercourse. AAPLOG notes that the
most common reason young women visit a physician is to obtain contraception. The Association
comments that it is in that environment where women have the best chance to be properly counseled, have
detection of STDs, and make their best selections for family planning. FDA should not approve Plan B
for OTC use but continue to require the use of a prescription so women of all ages will be provided the
necessary medical care they deserve.
<39: 1.2.3>A physician contact shared his experience with providing emergency contraceptives to CWA.
He maintains that most women and teenage girls are uneducated about the risks associated with being
sexually active, including cervical cancer, human papilloma viral (HPV) infection, and other sexually
transmitted diseases. Women under the age of 17 are at high risk for cervical cancer because the cells on
the cervix are more sensitive to HPV infection. About the age of 17, these cells become covered with
more protective cells. HPV infections cause cancer that can sterilize the woman, increase the risk of
miscarriages in the future, or death. Because of the prevalent ignorance of the risks of HPV and cervical
cancer, clinical standard of care requires a pap smear for cervical cancer screening before patients may
receive a prescription for birth control pills. This physician argues that if birth control pills or MAP are
ever made available OTC, cervical cancer rates will skyrocket, since the incentive to have pap smears
done will largely cease in this at risk population. The physician reasons that when a shortcut is created for
women to obtain contraceptive services without seeing a health professional, women who are ignorant of
STDs and their long-term effects, will remain ignorant. [Footnote 22: Physician comments are on file
with the author, by Donald F. Thompson, MD, MPh, TM, Colonel, USAF, MC, SFS, National Defense
University, Fort McNair, Washington, DC, (the comments reflect this physician's personal experiences
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and do not represent the views of the NDU or the federal government). His anecdotal experiences are as
follows: "I was caring for a 20 year old woman who was a junior in college, where I was performing
periodic pap smears and microscopic examinations (colposcopyy) of her cervix after her outpatient
cryosurgery to treat the precancerous changes discovered on an earlier pap smear. As part of my
evaluation, I always identify risk factors that help identify which patients are at high risk versus lower risk
so treatment and counseling can be directed most appropriately. This young lady was at high risk because
she had had over three lifetime sexual partners (she had had four), and she had first had sex at age 15
(anytime before age 17 is high risk because of HPV sensitivity). When I asked her what she had been
taught in high school about sex and its risks, she said that the risks were just glossed over and that the
message was that if you are going to have sex, then you just needed to use birth control to avoid getting
pregnant. No one had ever explained the other risks of sex, like cervical cancer and other sexually
transmitted infections. Another patient was a 17 year old who had only started having sex in the previous
year and had only had one sexual partner. She was referred for evaluation of an abnormal pap smear that
was discovered during her first exam when she was prescribed birth control pills for the first time. Her
colposcopic exam was abnormal, and I did several biopsies of her cervix. When I tried to schedule her for
a follow-up exam two weeks later, her main concern (and that of her mother) was that the appointment
not conflict with her high school graduation celebration. Her biopsies came back highly abnormal, with a
result of carcinoma in situ, a condition that required urgent surgery to remove the cancer before it spread.
Instead of celebrating the major step of graduating high school with her classmates, she was faced with a
diagnosis of cancer and the anxiety of wondering if the cone biopsy of her cervix was able to get all the
cancer, and if she was ever going to be able to get pregnant and carry a baby to term. She and her mother
were totally ignorant of the risks of sexually transmitted infections and cervical cancer and had only come
into the clinic to get birth control pills so she would nor get pregnant. If she had been able to get the MAP
without seeing a healthcare professional, she probably would have gone on to develop invasive cervical
cancer in the next year because of the aggressive strain of human papilloma virus with which she was
infected. I had another 18 year old patient who suffered from anorexia nervosa. She had an insatiable
need for reassurance from others, and moved from one dependant relationship to another, using sex as the
foundation for her relationships. I treated her and one boyfriend for Chlamydia and worked closely with
our counseling center to provide supportive services for her issues with her distorted body image. Despite
cautions, about sexual activity and sexually transmitted diseases, she continued in self destructive
relationships, Our clinic had a policy that the MAP must be provided to anyone who requested it, and she
was a regular client on Monday mornings. Despite counseling, she refused to think ahead and use other
forms of birth control, but instead continued to engage in "spontaneous" sexual activity since she had easy
access to the morning after pill. ]
Published studies support this concern. A study published in 2001 found that EC users
were more likely than controls to have never had a pelvic examination (26% vs. 6%, P<0.002) or a Pap
smear (24% vs. 6%, P<0.002) (Stewart HE., et. al,, The Impact of Using Emergency Contraception on
Reproductive Health Outcomes: A Retrospective Review in an Urban Adolescent Clinic, J. Pediatric
Adolescent Gynecology, 2001 Nov, 14(4): 163-9). A Washington State Pharmacy study published in
2001 found that among 126 adolescents who obtained EC directly from a pharmacist without a
prescription, 81% needed a new method of ongoing contraception, an evaluation for sexually transmitted
disease, or both. The study concluded that many adolescents using EC need additional medical care and
recommended that programs designed to increase EC access should use opportunities to link adolescents
with more comprehensive reproductive health care services. (Sucato, G.S., Adolescent's Use of
Emergency Contraception Provided by Washington State Pharmacists, Contraception, 2001 March;
63(3):123-129.)
An article from the International Peace Maternity and Child Health Hospital of the China Welfare
Institute stated that although reported ectopic gestation after failed EC have been rare, clinicians should
be aware of the possibility of an ectopic gestation when an EC pill fails. The department recommended
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women use the established service networks to enhance education and dissemination of information on
emergency contraception. The dearest also urgently advised that health care providers should advise
women very clearly that ectopic gestation is possible after failed EC treatment. (Jian, Z., Linan, C.,
Ectopic Gestation Following Emergency Contraception with Levonorgestrel, Contraception, 2002
December, 66()6: 433-437).
<40: 1.2>A discussion of the medical/societal discourse on whether life begins at fertilization,
conception, implantation or the embryo stage is beyond the scope of these Comments. FDA would be
remiss, however, if it did not acknowledge that women's views differ on this point in the U.S. At least one
national survey shows that almost half of American women believe that human life and pregnancy begin
at fertilization (Zogby J., American values, vol. V: Zogby International, 2000.) Similarly, a 1998 survey
of physicians who were predominantly ACOG members noted that 50% indicated that pregnancy begins
with fertilization (Spinnato JA., Informed consent and redefining of conception: a. decision ill-
conceived?, J. Matern. Fetal Med. 1998; 7:264-,268.) Likewise, whether a "therapeutic" effect of Plan B
that may occur after fertilization but before implantation could be consistent with the term abortifacient
will not be discussed here. Given these facts, however, the RX-to-OTC switch of Plan B and resultant
removal of physician involvement from the use of this drug has negative implications for patient informed
consent. Specifically, via informed consent, patients should fully understand the risks and benefits of the
drugs they take. Even strong proponents of EC agree that women should be informed about its
mechanisms of effect for adequate consent. See Drazen; J.M., Green, M.F. Wood, A.J.J., The FDA,
politics, and Plan B [letter]. N. Engl. J. Med 2904; 350:2414. Only through the physician/patient
relationship can a patient's .philosophical or religious convictions and Plan B's contraceptive mechanisms
be addressed. OTC labeling alone cannot adequately describe these biologically-sophisticated and morally
controversial issues. see, e.g., Letters to the Editor, Contraception 72 (2005) 394-395.
<41: 1.2, 1.2.3, 3.5.1, 3.11>C. FDA's Jurisdiction Over the "Safety and Efficacy" of Drugs Provides it
With Sufficient Authority to Consider Potentially Negative Societal Ramification Related to the OTC
Sale of Plan B
FDA's jurisdiction over the "safety and efficacy" of drugs provides it with legal authority to consider
morality, misuse, age-appropriate sexual behavior, and related social issues in the context of the Plan B
approval for OTC marketing. [Footnote 23: Those who argue that morality should not, affect FDA's
decision-making hypocritically cite moral judgments in support of the OTC approval of Plan B. For
example, certain Congressional representatives have asserted that "Public health experts have estimated
that over-the-counter sales of the emergency contraception pill Plan B would cut the rate of unintended
pregnancies in half and reduce the number of abortions by more than 500,000 per year." U.S. Reps. Henry
Waxman, D-CA, and Louise Slaughter, D-NY, circulated a "Dear Colleague" letter and Fact Sheet on
October 12, 2005, referencing these factors as a reason that FDA should approve the OTC sale of Plan B.
FDA cannot take the Societal concern of unintended pregnancies into account, while refusing to consider
the social concerns of an increase in unprotected sex and STDs, off-label over-use/repeat, use of Plan B,
and sexual abuse.] There is no question that FDA can and should, as a matter of law, take issues of
morality and social conscience into account when those issues relate directly to the drug's risk/benefit
analysis or safety/efficacy profile -two concepts with which FDA has decades of experiences and" for
which the courts provide deference to the Agency. If there is evidence that the expected patient
population is likely to use the drug in a way that decreases the drug's safety, negatively impacts the
patient's health, or tips the risk/benefit balance toward greater risk, FDA must consider this evidence
when addressing the approval decision. FDA routinely takes potentially harmful patient use scenarios into
account in its NDA approval decisions, whether for potent pain drugs (for which abuse and misuse are
Agency considerations), for obesity drugs (for which preferences for nutritive and exercise are Agency
considerations), or for HIV home test kits (for which the patient's mental well-being and need for a
learned intermediary or counselor was an Agency consideration). OTC emergency contraceptives fall
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squarely within this listing of drugs in which self-destructive patient actions may cause more harm than
good. [Footnote 24: FDA should reject the argument posited by some that an FDA decision denying
OTC approval to Plan B is too paternalistic. FDA has ample precedent over the years where it has made
an "unpopular" decision for reasons that were arguably paternalistic. FDA's mission is to protect the
public health by assuring the safety, efficacy, and security of human drugs. FDA has viewed this mission
broadly over the years to include the ""blocking" of access to certain drug products that, while safe and
effective on a scientific basis, were not appropriate for OTC use for broader public health reasons. For
example, the FDA removed phenacetin from the market after use as an ingredient, in OTC drug products
for over 80 years. In the FDA's notice of the withdrawal of phenacetin from the market, the basis cited for
approval was "phenacetin's high potential for misuse and its unfavorable benefit-to-risk ratio when
incorporated in analgesic combinations which are then subject to excessive chronic use." (Emphasis in
original) 48 Fed. Reg. 45486 (Oct. 5, 1983). In the proposed rule, the FDA stated that phenacetin was not
alone among analgesics in its ability to cause nephropathy, but because of its greater likelihood for abuse,
the agency believed other safe and effective analgesics would be sufficient for consumers. 47 Fed. Reg.
34636, 34638 (Aug. 10, 1982). Similarly, in 1972 the FDA severely restricted the allowable OTC uses for
the drug hexachlorophene as an antibacterial product. The restrictions on the use of hexachlorophene
followed the deaths of a number of infants in France due to the use of a baby powder contaminated with
six percent hexachlorophene. 37 Fed. Reg. 20160 (Sept. 27, 1972). Although hexachlorophene was
recognized as a safe and effective bacteriostatic skin cleanser, FDA concluded that a "risk to benefit ratio"
analysis justified restriction of the availability of the drug even though the at-risk population was
extremely small. Id. ]
<42: 1.2>1. OTC Sale of Plan B Would Further the Interests of Sexual Predators
Evidence suggests that making Plan B available OTC would serve to further the predatory interests of
sexual offenders who molest family members, children of friends, or students, as well as adult
"boyfriends" who commit statutory rape. Namely, rapists and sexual predators could "stock up" on
emergency contraceptives and keep a ready supply in, for example, their bedroom drawers or pockets to
give to their victims after committing each sexual crime. [Footnote 25: For our discussion on the societal
ramifications of OTC marketing for emergency contraceptives, we draw on the Written Testimony of Jill
L. Stanek, on behalf of CWA of Illinois, regarding the MAP, presented at the Joint Meeting of the FDA
Nonprescription Drugs Advisory Committee and the FDA Advisory Committee for Reproductive Health
Drugs (Docket No. 01P-0075) (Dec. 16, 2003).. This written testimony can be found at
http://www.cfa.org/articles/4998/CWA/life/index.htm (last accessed October 29,2005).] Cf. Press
Release for Congressman Don Manzullo 16th District of Illinois, entitled "Manzullo's Title X Statutory
Rape Reporting Provision" Will Become Law" (Oct. 21, 1998) (noting the incident of a 37-year-old
teacher having his 14-year-old student take birth control injections so that he could "continue molesting
her at will"'). See also Paul Bissell & Claire Anderson, Supplying Emergency Contraception Via
Community Pharmacies in the UK: Reflections on the Experiences of Users and Providers, 57 Social
Science & Medicine 2,367 (2003) (noting the concern that the widened availability of EC might provide
an opportunity for men to coerce women into having unprotected sexual intercourse against their will).
In fact, several studies have shown that men are the most frequent buyers of MAP and that many learn
about these drug products from advertisements in men's magazines. See Karnjariya Sukrung, Morning-
After Blues, Bangkok Post, June 10, 2002. The Bangkok Post further states that "[sexual predators], buy
pills for their girlfriends or wives so that-they don't have to wear condoms.. . Some women,. . said they
that they didn't even know what they were taking; that the guy just said it was a health supplement." See
id. The Bankok Post continues, "Although many feminists believe that the morning-after pill gives them
more control over their own bodies, it would seem, judging from the few studies conducted so far, that it
is actually being used by men to exploit women." See id. Thus, the unrestricted access of Plan B would
give these sexual predators another method to shield their abusive behavior. OTC Plan B opens the door
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farther to sexual predators by reducing a woman's bargaining power at the critical moment when the
decision is made whether or not to have sex.
<43: 1.2>The OTC availability of the MAP would in fact only increase this likelihood of sexual abuse of
young girls by adult men. Without a link to medical services for emergency contraceptives, the likelihood
is much greater that a sexual predator will continue to commit his crime without detection and with
greater frequency if he can find a way to keep his victim from seeing a licensed physician to seek
contraception. Cf. Cathy O'Leary, Abbott Wants Clamp on Morning-After Pill, The West Australian,
June 8, 2004. How much more will minor girls be exploited if emergency contraceptives are available
OTC? OTC access to emergency contraception will increase the likelihood that sexual perpetrators will
go undetected and that young girls will be sexually abused. Switching Plan B to OTC would thwart
Congressional attempts to protect minors from sexual abuse.
Conversely, if Plan B remains in the Rx-only category; physicians will remain involved with its
prescribing and the potential for proper reporting of sexual predators will be increased. CWA has received
comments from a physician advocating that victims of sexual abuse need medical consultation, not quick
fixes in complete secrecy and isolation. According to APFLI, public health policy dictates that victims of
rape or incest should be encouraged by medical professionals to go to a hospital emergency room where
equipment and training advances the collection of forensic evidence and the provision of victim care.
Similarly, AAPLOG comments that there is no question that Plan B OTC will become the leading "rape"
drug in the country. AAPLOG is apprehensive of the "'benefits"" of Plan B OTC .for sexual predators;
namely, quietly hiding the rape, leading to "covering up" of crime, and the victim's perception of a second
societal abuse, since rapes are criminal matters that require medical examination to assess injury, collect
forensic evidence, get baseline STD testing, and possibly treat infections.
<44: 1.2>2. OTC Sale of Plan B Would Exacerbate -The Abuse of Teenage Girls
Evidence also suggests a relationship between the age of a woman, the risk of abuse, and the likelihood of
pregnancy. For example,. Planned Parenthood reported that teenage girls with older partners are more
likely to become pregnant than those with partners closer in age. [Footnote 26: As noted in the Written
Testimony of Jill L. Stanek.] Among women younger than 18, the pregnancy rate among those with a
partner who is six or more years older is 3.7 times as high as the rate among those whose partner is no
more-than two years older. See M. Joycelyn Elders, Adolescent Pregnancy and Sexual Abuse, 280
Journal of Amer. Med. Assoc. 648 (1998) (noting that "coercive sex acts against adolescent girls are
frequently perpetrated by their boyfriends . . . . .Boyfriends who are considerably older than their
adolescent girlfriends have been found to be responsible for a majority of teen pregnancies").
Furthermore, Planned Parenthood also reported that teenagers who have been raped or abused also
experience higher rates of pregnancy -in a sample of 500 teen mothers, two-thirds had histories of sexual
and physical abuse, primarily by adult men averaging age 27. Cf. ME. Joycelyn Elders, Adolescent
Pregnancy and Sexual Abuse, 280 Journal of Amer. Med. Assoc. 648 (1998) (noting that sexual abuse is a
common antecedent of adolescent pregnancy, with up to 66% of pregnant teens reporting histories of
abuse). Thus, evidence indicates that sexually active young girls are likely to be the victims of sexual
abuse and carry a higher risk for pregnancy.
This relationship between age and abuse suggests the particular vulnerability of young girls to sexual
abuse. If FDA approves Plan B for OTC use, this medication will be more readily available, and sexual
predators will in effect have lower barriers to restrain their actions - they will have less fear of
impregnating a woman, and the patterns of abuse will become more prevalent. This abuse will in turn
target younger victims, as indicated by the correlation discussed above.
<45: 1.2>3. OTC Sale of Plan B W ill Not Reduce the Number of Abortions and Unintended Pregnancies
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A potential reduction in the number of abortions and unintended pregnancies is not a sufficient reason to
allow the OTC marketing of Plan B, and evidence exists to the contrary. While some argue that Plan B
OTC status is desirable because the unwanted pregnancy rate and abortion rate would decrease, studies
indicate that this relationship may not be true. One study showed that the advanced provision of
emergency contraceptives had no effect on abortion rates. See Anna Glasier, Karen Fairhurst, et al.,
Advanced Provision of Emergency Contraception Does Not Reduce Abortion Rates, 69 Contraception
361 (2004). See also Stuart Nicolson, Morning-After Pill Campaign Fails to Stem Abortion Rate, Daily
Mail (London), December 3, 2004 (noting that new research indicates that distributing EC more freely
does nothing to reduce the number of abortions).
Further research, released on January 5,2005, also fails to support the contention that OTC marketing of
Plan B would decrease the number of pregnancies. A study of 2,117 young women ages 15-24 reported in
the Journal of the American Medical Association (JAMA) demonstrated that providing young women
with non-prescription access to emergency contraception did not lead to any decrease in the pregnancy
rate. Even women provided with an advance supply of EC did not have a decreased pregnancy rate. The
study demonstrates that readily available EC does not lead to a reduction in unintended pregnancies,
despite erroneous claims to the contrary by the study's conclusion and other EC proponents. See Raine,
TR, et al, Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended
Pregnancy and STIs, JAMA 2005, 293:54-62, at www.jama.com. [Footnote 27: CWA has received
comments questioning whether the author's conflict of interest dilutes the significance of certain studies.
CWA understands that Dr. Tina R. Raine served on the expert advisory panel for the Sponsor for the OTC
application of Plan B to the FDA. She did so while at the same time arranging to conduct two studies
designed to directly counter the concerns raised by opponents of Plan B's OTC status.
<46: 10>Dr. Raine previously published a study that ostensibly refutes any concerns about possible
increased STDs and risky sexual behavior in women with EC availability (Emergency Contraception:
Advance Provision in a Young, High-Risk Clinic Populations (Obstetrics & Gynecology 2000; 96: l-7).
Interestingly enough, her study cites data that women in the treatment group (those that had access to EC)
were more likely than those in the control group to report using less effective contraception. Furthermore,
the women who did not have access to EC were more likely than the treatment group to report consistent
birth control pill use. Raine's study demonstrates that easier access did not lead to changes in risky sexual
behavior or routine contraception use. The Raine study clearly shows that there was no difference in
pregnancy rates between those women who had access to EC, and those who did not. In other words, the
very justification for proving EC, namely decreased unintended pregnancies, was lacking. [Footnote 28: If
the rebuttal to this concern is that the study was not large enough to find a difference in this young age
group, the same argument can be made regarding the lack of differences they found in teens' sexual
behavior or the rate of acquiring new STDs. In other words, if one argues that it will take time for
pregnancy rates to decrease, or a larger population studied to see the benefit, then one can just as properly
argue that with time or a larger population size, one will also see an increase in risk-taking behavior and
an increase in STDs among these individuals.] Furthermore, the adolescents in this study stated
themselves that they would have more unprotected intercourse with the availability of EC. The
examination of behavior in the study's short time frame of six months could not confirm this but, with the
passage of time, and with the increased comfort and familiarity with EC, CWA's physician contacts
believe that this increased unprotected intercourse would likely occur.
Other CWA physician contacts have commented that in a review of ail studies relating to the topic of
OTC MAP and its effects on the sexual activity of women, there has not been found to be a difference in
either abortion rates or pregnancy rates. The groups in the studies are actually given advance provision of
the MAP, which is more aggressive than actually having access to the drug OTC. The women were also
in a clinical study setting, knowing they were under observation, and were educated and instructed
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regarding the drug's use. Presumably, the physicians note, this setting should be optimal to observe a
decrease in abortions and unintended pregnancies. Instead, the studies reflect no change, and in fact,
demonstrate increased risky sexual behaviors after experience with MAP access. Furthermore, to our
knowledge, there has never been a randomized study with a control group not utilizing MAP; therefore,
the comparative number studies used to prove efficacy over using nothing is simply anecdotal and not a
generally acceptable manner in which to determine the efficacy of a product.
<47: 10>AAPLOG highlights the UK study above and a separate San Francisco study, referenced herein,
showing that there is no difference in the abortion rate or in the unintended pregnancy rate between
women who are given the MAP free to take home for immediate use and women who have to obtain
prescriptions for MAP.
A CMDA member comments that there are multiple studies that show that easier access to contraception
increases sexual activity rates, decreases the age of onset of sexual activity, and increases the incidence of
STDs, One study found that pregnancy rates are unaffected by readily available MAP; that increasing the
availability of birth control to teenagers. increases STD rates, especially when MAP is made available;
and that teens make rational decisions based on available options (i.e., when contraception is less
available, they have sex less frequently). (David Paton, Random Behavior or Rational Choice? Family
Planning Teenage Pregnancy and STIs, Nottingham University Business School, UK, presented at the
Royal Economic Society Conference, April, 2004.) Another study shows that widespread distribution of
advanced supplies of MAP did not reduce unintended pregnancy, and MAP may be less effective than
believed; namely, efficacy is based on unreliable data and a great number of assumptions that have been
questioned both in the past and more recently. (Anna Glasier et. al, Advanced Provision of Emergency
Contraception does not Reduce Abortion Rates, Contraception 69 (5): 361-366, May 2004).
While it has been argued that OTC .MAP would reduce abortion rates by up to 50%, the evidence
presented does not support this contention. As noted above, a 2004 study showed that there was no effect
on abortion rates with the advanced provision-of-MAP. (Anna Glasier, et al., Advanced Provision of
Emergency Contraception Does Not Reduce Abortion Rates, Contraception 69 (2004) 361-366.) The
study suggested that widespread distribution of advanced supplies of MAP may not be an effective way to
reduce the incidence of unintended pregnancy. Indeed, in Great Britain, abortion rates have increased for
teenagers in the years since OTC availability. A UK article reports that there were 2.1% more abortions
performed in England and Wales in 2004 than 2003. In the last three years, abortions in the UK have
increased from 176,000 in 2002, to 181,000 in 2003, to 185,400 in 2004. (Steven Ertelt, British Abortion
Figures Show Increase of Two Percent in 2004, LifeNews Editor, July 27, 2005, London England.) The
number of abortions increased despite the government's spending 540 million to promote contraception.
Id. An article in the Observer, a British publication, states that since the morning-after-pill was made
available without prescription five years ago, there has been little change in teenage conception rates.
Teenage conceptions have fallen by about 10 percent, but in 13 local authorities with the highest rates, 11
have seen the numbers of teenage pregnancies increase. (The Observer, May 15, 2005, available at
http://observer.guardian.co.uk/magazine/story/0,11913,1484669,00.html.)
<48: 10>Similarly, while the sales of emergency contraceptives have risen, sharply in Belgium, there
appears to be no signs of a reduction m the number of abortions. See Abortions "Rise " Despite Morning
After Pill, Expatica, August 27, 2004 (stating that some "estimate that the number of abortions has gone
up, despite the morning after pill").
In Scotland, one in five 16 year old girls takes the morning-after-pill each year. However, the birthrate for
l6-19 year olds rose from 63.6/1000 in 1983 to 68.1/1000 in 2004. (Julia Hunt, Experts Fear Rise In
Infertility as Chlamydia Cases Soar by 66 Percent, Scottish Daily Record & Sunday Mail, May 2, 2004,
pg. 40,41.)
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In Sweden, teenage pregnancies declined from 1975-l 985; abortions decreased as well. However, in the
late 1980s, abortions increased. A changing pattern of contraceptive use was discussed as a contributing
factor (e.g., less use of oral contraceptives due to fear of adverse effects). Since then, subsidies for oral
contraceptives have emerged, and emergency hormonal contraception has become easily available. In
spite of these factors, teenage abortion rates have been increasing, from 17/1000 in 1995 to 22.5/1000 in
2001. Furthermore, widespread availability of sexual education, contraception, and abortion services does
not protect teenagers from STDs, pregnancy, and sexual victimization. (K. Edgardh, Adolescent Sexual
Health in Sweden, Sexually Transmitted Infections: 2002; 78:352-356.) AAPLOG notes that in the 5
years following non-prescription EC availability, Sweden experienced a 31% increase in teen abortion.
(K. Edgardh, Adolescent Sexual Health in Sweden, Sexually Transmitted Infections, 2002,78: 352-356.)
A Swedish study assessing the short- and long- term risk of unintended pregnancy in women receiving
emergency contraception (and contraceptive counseling) found that in a long-term follow up, 10 of 134
women experienced an unplanned pregnancy, 9 of which resulted in abortions. All these women had
either started and terminated oral contraceptives or had never commenced the prescribed oral
contraceptives.. The study concluded that women who request emergency contraception are, despite a
planned follow-up with contraceptive counseling, a high risk group for new unintended pregnancies.
(Falk, G. et al, Young Women Requesting Emergency Contraception Are, Despite Contraceptive
Counseling, a High Risk Group for New Unintended Pregnancies, Contraception, 64(1):23-27 (July
2001)).
Given that accumulating sound scientific evidence that OTC access to EC doesn't decrease unintended
pregnancy or abortion rates, any claim that OTC access will cut these social ills betrays the public trust.
[Footnote 29: See AAPLOG News Release, Statement of the American Association of Pro-Life
Obstetricians and Gynecologists on JAMA Emergency Contraception Study, January 12, 2005.]
Moreover, any FDA reliance on such argument is improper and unsupportable.
<49: 1.2>D. It Is Unlawful For FDA To Approve the Plan B NDA Supplement Without Data from a
Clinical Study Involving the Relevant Pediatric Subpopulation
In a case where the Sponsor intends to label a drug for use in the pediatric population, FDA has only
limited authority to cede the requirement for pediatric testing. [Footnote 30: We note that Plan B is not
eligible for a waiver of the pediatric requirements. FDA may grant a full waiver of the requirement to
submit pediatric assessments only if the applicant certifies and FDA finds one or more of the following:
(a) Necessary studies are impossible or highly impracticable (because, for example, the number of
patients is so small or the patients are geographically dispersed) (section 505B(a)(4)(A)(i) of the Act). (b)
There is evidence strongly suggesting that the drug or biologist product would be ineffective or unsafe in
all pediatric age groups (section 505B(a)(4)(A)(ii) of the Act). (c) The drug or biological product, (1) does
not represent a meaningful therapeutic benefit over existing therapies for pediatric patients, and (2) is not
likely to be used in a substantial number of pediatric patients (section 505B(a)(4)(A)(iii) of the Act). See
Draft Guidance for industry: How to Comply with the Pediatric Research Equity Act (2005), pp. 9-10.
Plan B does not fulfill any of these conditions. First, studies are both possible and practicable. Secondly,
the Sponsor of OTC marketing for Plan B seeks the Rx-to-OTC switch precisely because it presumes that
Plan B would be safe and effective in pediatric age groups. Lastly, the intention of marketing Plan B OTC
specifically contemplates the drug's use in a substantial number of pediatric patients. Thus, Plan B does
not meet any of the criteria for a full waiver of pediatric requirements.] FDA cannot approve an NDA or
an NDA Supplement without the submission of data that are adequate (1) to assess the safety and
effectiveness of a drug product in pediatric subpopulations and (2) to support dosing and administration in
these subpopulations. See 21 U.S.C. § 355(a)(2).
The Pediatric Research Equity Act (Public Law 108-l 55) (PREA), which amended the FDC Act, requires
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the conduct of pediatric studies for NDAs and NDA Supplements requesting approval for a new
indication and a new dosing regimen, among other items. See 21 U.S.C. § 355c(a)(1); see also Draft
Guidance for Industry: How to Comply with the Pediatric Research Equity Act (2005), p. 3 (hereafter,
"Pediatric Research Guidance") (stating that PREA requires all NDAs or NDA supplements to contain a
pediatric assessment). Because PREA makes this legislation retroactive, all NDAs submitted on or after
April 1, 1999 are subject to PREA. See id. The Plan B NDA Supplement was submitted after April 1,
1999 and requested approval for the new indication/dosing regimen of OTC use by women 16 years and
older for pregnancy prevention and, thus, is subject to the PREA requirements.
<50: 1.2.3>PREA requires the submission of a pediatric assessment "in all relevant pediatric
populations." PREA requires a pediatric assessment for each age group in which the drug product is
expected to provide a meaningful therapeutic benefit over existing therapies for pediatric patients or is
likely to be used in a substantial number of pediatric patients. See Pediatric Research Guidance (emphasis
added). A "pediatric assessment" consists of data gathered from pediatric studies using appropriate
formulations for each age group for which the assessment is required, as well as other data that are
adequate to assess the safety and effectiveness of the drug product in pediatric subpopulations and to
support dosing and administration for each pediatric subpopulation. See 21 U.S.C., § 355c(a)(2). See also
Pediatric Research Guidance.
In the case of Plan B, a pediatric assessment should have been required for two pediatric subpopulations:
Children, ages 2 to 12, and adolescents, ages 12 to 16. Given its indication as an emergency
contraceptive, the Plan B patient population logically includes all females who can become pregnant - that
is, as of the age their first menstrual period begins (i.e., "menarche") until they no longer have a menstrual
period (i.e., "menopause"). According to FDA, the average age of menarche in the United States is 12
years, although menstruation may commence in healthy females as early as age 10. [Footnote 31: See On
the Teen Scene: A Balanced Look at the Menstrual Cycle, FDA Consumer Magazine (Dec. 1993)
(available at http://www.fda.gov/fdac/reprints/ots_mens.html). In the U.S., the average age of the start of
menopause is 51. See Taking Charge of Menopause, FDA Consumer Magazine (Nov.-Dec. 1999)
(available at http://www.fda.gov/fdac/features/1999/699_meno.html).] In the past, the Agency defined
"pediatric population(s)" and "pediatric patient(s)" as the age group "from birth to 16 years, including age
groups often called . . . adolescents." [Footnote 32: See, formerly, 21 C.F.R. § 201.57(f)(9).] Therefore,
the population of menstruating females (i.e., 10 or 12 and older) and the pediatric population (i.e., up to
16) overlap by up to 6 years, Because Plan B will be used by some number of adolescent girls who
become pregnant, FDA should have required the Sponsor to produce specific and statically relevant safety
and effectiveness data for the pediatric population. Extrapolation from adult data alone is not appropriate
for this product because of the broad range of "normal", physiologic issues experienced by the
subpopulation of adolescent girls. The safety and effectiveness data in adults would not be sufficiently
similar to the under-l 7 subpopulation to support such extrapolation. See Pediatric Research Guidance, at
5-6.
<51: 1.2.3>If a pediatric assessment is not submitted by an applicant in accordance with PREA, not only
may FDA deny approval to the drug application, but also the drug product may be considered misbranded
solely because .of that failure to submit a pediatric assessment, See Pediatric Research Guidance. Thus, if
a firm submits a supplemental NDA providing for a switch of a drug product from Rx-only status to OTC
status (for a certain subpopulation based on age, for example), that firm would need to submit a pediatric
assessment in order to comply with the provisions of PREA. The need for such an assessment is
especially salient for a drug product intended to be sold OTC (even if just for adults) because of the high
likelihood of such a drug product to be used in a substantial number of pediatric patients - whether access
is obtained improperly through a "black market" scenario or lawfully with physician supervision.
After more than a decade of supporting "'the legislative and regulatory attempts to address the lack of
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pediatric use information in drug product labeling" that culminated in the PREA, it is curious that, here,
FDA failed to require a pediatric study for a drug that is being marketed specifically to the under-16
patient subpopulation. See Pediatric Research Guidance, at 2.
<52: 1.2.3>E. It Is Unlawful for FDA to Approve the Plan B NDA Supplement on The Basis of the
Sponsor's Label Comprehension/Actual Use Study
FDA balances numerous factors when considering a drug sponsor's application for an RX-to-OTC switch.
First and foremost, patients using an OTC drug should be able to self-medicate after reading the drug's
labeling, Consequently, FDA expends considerable effort to analyze the results of label comprehension
studies conducted by the drug sponsor. FDA's review of the Sponsor's label comprehension study was
presented on December 16, 2003, by Dr. Karen Lechter at a joint meeting of the FDA's Nonprescription
Drugs Advisory Committee and its Advisory Committee for Reproductive Health Drugs, and shows that
the Sponsor's study is not adequate to support the Rx-to-OTC-switch of Plan B. [Footnote 33: FDA,
Center for Drug Evaluation and Research, Nonprescription Drugs Advisory Committee (NDAC) in Joint
Session with the Advisory Committee for Reproductive Health Drugs (Dec. 16, 2003) ("Joint Hearing"),
at 118-124. Dr. Lechter (J.D., Ph.D) is an FDA social scientist.]
The information presented casts considerable doubt on FDA's conclusion that Plan B can be safely self-
administered by adults - not to mention by adolescent girls. [Footnote 34:
http://www.fda.gov/ohrms/dockets/ac/03/slides/4015s1.htm.] Only 75% of all respondents answered that
Plan B should not be taken in the presence of unexplained vaginal bleeding. Among the low-level literacy
group that figure declined to 69%; with high-literacy respondents answering correctly only 81% of the
time. Thus, one-quarter of all respondents failed to understand this crucial fact. [Footnote 35:
http://www.fda.gov/ohrms/dockets/ac/03/slides/4015S1_04_FDA-Lechter_files/frame.htm.] Only 67% of
all respondents answered correctly that Plan B is designed to serve as a backup for regular contraception
methods -not as a replacement for them. Among those of low-literacy this figure dropped to 46%;
whereas for women of high literacy the figure was 78%. [Footnote 36:
http://www.fda.gov/ohrms/dockets/ac/03/slides/401581_04_FDA-Lechter_files/frame.htm.]
Accordingly, one-third of al1 respondents failed to understand that Plan B is not a typical method of
contraception.
<53: 1.2.3>Given results like these it is not surprising that Dr. Louis Cantilena (M.D., Ph.D.), Plan B
Joint Hearing, noted that "if you look at other studies that . . . we've heard about in the past for statins and
the heartburn drugs, the overall success of the [Plan B] comprehension study was really not that good[.]"
[Footnote 37: Joint Hearing at 136.] Later, Dr. Cantilena observed, "The label comprehension] study
was, I think, an overall failure." [Footnote 38: Joint Hearing at 411.]
Furthermore, Dr. David Hager asked the FDA panelists about data received from Washington State
pharmacists who had participated in Plan B's actual use studies. The pharmacists indicated that 85% of
the Plan B patients required medical follow-up - usually consisting of medical evaluation and counseling.
Dr. Hager asked whether there was any concern about a potential failure to diagnose ectopic pregnancies
in this population if the drug were made available OTC. [Footnote 39: Joint Hearing at 137.] Dr. Hager
does not appear to have received an answer to his question during the hearing. The question needs to be
asked: if 85% of a population of women using Plan B needed medical follow-up, how will those patients
receive the care and information they need in an OTC environment?
<54: 1.2.3>FDA improperly focused its concerns on whether Plan B could be safely used by young
teenage girls, rather than considering also women with pathophysiologjcal issues. In FDA's 2004 "Not
Approvable Letter" to the Sponsor, Dr. Steven Galson noted that FDA had "concluded that you have not
provided adequate data to support a conclusion that Plan B can be used safely by young adolescent
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women for emergency contraception without the professional supervision of a practitioner licensed by
law to administer the drug." [Footnote 40: Not Approvable Letter, Steven Galson, M.D., Acting Director
of the Center for Drug Evaluation and Research, FDA, to Barr Research, Inc. (May 6, 2004) at 1. Galson
noted the small sampling of adolescent women in Barr's actual use study: "You propose OTC status for
Plan B for both adults and children based primarily on an actual use study in 585 subjects. Only 29 of the
585 subjects enrolled in the study were 14-16 years of age, and none was under 14 years of age." Id.]
The Sponsor chose not to propose new label comprehension and actual use studies designed to
demonstrate Plan B's safety in this younger population. Rather, the Sponsor redoubled its efforts to
advance a proposa1 it had made to FDA on March 11, 2004 in an amendment to its application that called
for a dual approach for Plan B in which the drug would be available OTC to women 16 and older and as a
prescription drug for women under age 16. [Footnote 41: See Not Approvable Letter, Lester M.
Crawford, DVM, Ph.D., Commissioner, FDA, to Duramed Research, Inc. (Auguust 26, 2005),
referencing Sponsor's Research Submission of July 21, 2004.]
As stated above, we believe that FDA lacks the legal authority under section 503(b) of the FDC Act to
allow this drug product to be sold OTC to women 17 years old and over while requiring a prescription for
girls under 17. With that in mind, FDA should reexamine the abysmal results produced by Plan B's
proposed labeling in the Sponsor's label comprehension study. It is our contention that FDA erred in
concluding that the drug could be safely distributed even to adults OTC, and we ask FDA to reconsider
that decision. If it does not reconsider that decision, the Agency should state what standards it uses to
evaluate when label comprehension failure becomes so great that OTC sale is not supportable.
<55: 1.2.3>CONCLUSION
There can be no legal or scientific doubt that Plan B is unsafe for women under age 16 as an OTC
product, since the Sponsor's July 21, 2004 submission admits this explicitly. Since the Plan B label
comprehension study, actual use study, and FDA's safety analysis have not been altered by any new
evidence presented by the Sponsor, the Agency must conclude that even on the Sponsor's terms Plan B is
not safe for girls under 16 years of age for OTC sale. Furthermore, because FDA lacks the legal authority
to approve the simultaneous dual marketing of an active ingredient in the Rx and OTC distribution
regimes, Plan B cannot legally be sold as an OTC product to any age group.
Sincerely,
Gary L. Yingling, J.D., M.S.
Rebecca L. Dandeker, J.D.
On Behalf Of:
Wendy Wright
Executive Vice President
Concerned Women for America
Joseph L. DeCook, MD., FACOG
Vice President
American Association of Pro-Life Obstetricians & Gynecologists
Christopher M. Gacek, J.D., Ph.D.
Senior Fellow for Regulatory Affairs
Family Research Council
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David Stevens, M.D., M.A. (Ethics)
Executive Director
Christian Medical and Dental Associations
November 2,2005 Fax: 202.778.9100
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Comment to Docket No. 2005N-0345; RIN 0910-AF72
Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a
Prescription Drug Product and an Over-the-Counter Drug Product
To Whom It May Concern:
Please file the attached original Amended Comments in Docket No. 2005N-0345 and file stamp and
return the additional copy to my messenger. The Amended Comments should replace the Comments filed
by this author by facsimile at 4:45 p.m. yesterday, November 1, 2005. The Amended Comments include
corrections to typographical errors and misstated citations, and add the signatory of CMDA.
Thank you for your attention to this matter.
Sincerely,
Gary L. Yingling
Enclosures
COMMENT NUMBER - 2005N-0345-C415
2005N-0345-C415 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
2005N-0345-C415 - TEXT
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
RESPONSE OF DURAMED PHARMACEUTICALS, INC. AND DURAMED RESEARCH, INC. TO
ADVANCE NOTICE OF PROPOSED RULEMAKING
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DRUG APPROVALS: CIRCUMSTANCES UNDER WHICH AN ACTIVE INGREDIENT MAY BE
SIMULTANEOUSLY MARKETED IN BOTH A PRESCRIPTION DRUG PRODUCT AND AN
OVER-THE- COUNTER DRUG PRODUCT
Docket No. 2005N-0345
RIN No. 0910-AF72
On September 1, 2005, the Food and Drug Administration ('"FDA ") published in the Federal Register an
Advance Notice of Proposed Rulemaking (Docket No. 2005N-0345) (the "Notice"). 70 Fed. Reg. 52,050
(Sept. 1, 2005). The Notice requests comment on whether FDA should initiate rulemaking to codify its
interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-399
("FDCA "), regarding when an active ingredient may be marketed simultaneously in both a prescription
("Rx") and an over-the-counter ("OTC ") drug product and other issues related to its consideration of
Supplement 011 to approved New Drug Application 21-045 ("NDA 21-045/S011").
Duramed Research, Inc. and Duramed Pharmaceuticals, Inc. (together "Duramed") respectfully submit
these comments in response to the above-referenced Notice. Duramed is the sponsor of the drug product,
Plan B, which is the subject of NDA 21-045-S011.
Duramed believes that Plan B is safe and effective for OTC use for all women - a view that is shared by
an overwhelming majority of the members of two separate FDA Advisory Committees, professional
healthcare organizations and practitioners. However, at FDA's suggestion, and consistent with FDA's
expression of concerns regarding the nonprescription use of the product by women under the age of
sixteen, Duramed has proposed, in a supplement to its NDA, a dual-label product that would be an OTC
product for women sixteen and older and a prescription product for women under sixteen.
EXECUTIVE SUMMARY
<1: 5.4.3>1. FDA's existing interpretation of section 503(b), 21 U.S.C. § 353(b)(1), regarding
simultaneous marketing of an active ingredient as an Rx and OTC product has not caused any confusion,
and therefore FDA does not need to initiate any rulemaking on its interpretation. As FDA states in the
Notice, it has repeatedly approved simultaneous Rx and OTC marketing in the past; and Duramed has not
been able to locate any evidence to support the contention that FDA 's interpretation of section 503(b) as
permitting such use is erroneous or needs clarification.
<2: 4.4.2>The public has been aware since at least May 2004 that FDA is considering permitting
simultaneous Rx and OTC marketing of Plan B to different subpopulations, yet Duramed has been unable
to find any basis to conclude that the FDCA does not authorize FDA to approve such marketing. It is
beyond dispute that, since Duramed filed its supplement, there has been extensive public discussion -in
articles and editorials in newspapers, professional journals, and other publications, on television and
radio, and elsewhere -of the issues relating to Plan B, including limitation of OTC to a particular
subpopulation. Interested members of the public have already had ample opportunity to express their
views to the Agency, and have done so. It is time for FDA to take final action on NDA 21-045/S011.
<3: 6.3.4, 7.3.1.2>2. FDA has authority to enforce the limitation of Rx products to a subpopulation, just
as it has authority to enforce the limitation of Rx products by indication, strength, route of administration,
and dosage form. Moreover, FDA can enforce this limitation in actual practice through a variety of
mechanisms, including, but not limited to, random inspections of pharmacies by FDA investigators and
coordination with state and local law enforcement officials. To aid in FDA's efforts, Duramed has
proposed a marketing program for Plan B that will include limiting distribution of Plan B to retail
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operations with pharmacy services and clinics. It will also include an educational component to help
ensure the compliant, safe and effective use of Plan B. This program would be designed to educate
pharmacists and health care practitioners on the Rx requirement for women age 15 and younger. It will
also educate women age 15 and younger to discuss Plan B with their health care practitioners.
<4: 8.3.1>3. Rx and OTC products can lawfully be sold in the same initial packaging, as long as the
products do not call for different doses, different strengths, or different directions for use. Because
marketing of Plan B to different subpopulations does not implicate any of these differences, the same
initial packaging can be used for Plan B when dispensed pursuant to a prescription and when dispensed
OTC. Specifically, FDCA § 503 can be satisfied by ensuring that all packages contain (i) adequate
information and directions to ensure safe, effective, and appropriate OTC use, (ii) the legend "Rx only for
women age 15 and younger," and (iii) appropriate space for the traditional Rx label, to be affixed by a
pharmacist when dispensing the product pursuant to a prescription.
<5: 2.1>These answers to the questions in FDA's Notice are straightforward and, we think, not seriously
in dispute. FDA has already determined that Plan B is safe and effective when dispensed OTC to women
age 17 and older, yet FDA's continued delay in approving OTC status for the drug when so dispensed is
effectively preventing or delaying women of all ages from obtaining the drug as soon as possible and
within its critical 72 hour period of effectiveness. This delay is contrary to the Agency's mission as set
forth in FDCA § 903(b)(1), 21 U.S.C. § 393(b)(1), to "promote the public health by promptly and
efficiently reviewing clinical research and taking appropriate action on the marketing of regulated
products in a timely manner."
BACKGROUND
<37: 1.2>Plan B is currently approved as a prescription drug indicated as "an emergency contraceptive
that can be used to prevent pregnancy following unprotected intercourse or a known or suspected
contraceptive failure." Plan B Package Insert. In a supplement to NDA 21-045 (S-011) submitted to FDA
on April 16, 2003, Women's Capital Corporation proposed that Plan B be switched from Rx to OTC
status. The American College of Obstetricians and Gynecologists has estimated that making Plan B
available OTC could prevent about 2 million pregnancies (about half of all unintended pregnancies in the
United States), and about 500,000 abortions, per year. [Footnote 1: Transcript of the December 16, 2003
meeting of the FDA Ctr. for Drug Eval. & Research, Nonprescription Drugs Advisory Committee in Joint
Session with the Advisory Committee for Reproductive Health Drugs, Dec. 16, 2003, 33, 37, available at
http://www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.DOC (hereinafter, "Hearing Tr."). Duramed
incorporates herein by reference the Hearing Transcript, which it presumes has been made part of docket
number 2005N-0345.] This objective can only be achieved if women who need Plan B have timely
access to the product.
Based on the scientific evidence regarding its safety and its benefit to the health of women, every relevant
leading medical organization in the United States supports the efficacy and safety of Plan B as an OTC
product. These organizations include the American Medical Association, the American Medical Women's
Association, the American College of Obstetricians and Gynecologists, the American Academy of
Pediatrics, the American Public Health Association, and the American Association of Family Physicians.
[Footnote 2: A copy of each organization's statement is attached hereto at Exhibit ("Ex.") l.]
<38: 6.6.1, 6.6.4>In September 2005, Massachusetts became the eighth State to permit enhanced access
to Plan B, by allowing pharmacists to dispense Plan B. The others are Alaska, California, Hawaii, Maine,
New Hampshire, New Mexico, and Washington. [Footnote 3: Alaska, see Alaska Stat. § 08.80 (2002)
(Bd. ed. Feb. 2003), Alaska Admin. Code Title 12 § 52.240 (Bd. ed. Feb. 2003); California, see Cal. Bus
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& Prof. Code §§ 4016, 4025, & 4050 - 4052; Hawaii, see Haw. Rev. Stat. § 461-1 ; Maine, 32 Me. Rev.
Stat. § 13821 ; Massachusetts, see SB 2073/HB 1643 ; New Hampshire, see N.H. Rev. Stat. § 318 :47-e;
New Mexico, see N.M. Stat. Ann. §§ 61-11-2, N.M. Reg. 16-19-26.9 ; and Washington, see Wash. Rev.
Code 18.64, Wash. Admin. Code § 246-863-100.] Over thirty countries worldwide - including Britain,
France, Australia, and Sweden -already permit such use.[Footnote 4: Center for Reproductive Rights,
"Governments Worldwide Put Emergency Contraception into Women's Hands: A Global Review of Laws
and Policies," 7 (Sept. 2004). Attached hereto at Ex. 2.] Most recently, in 2005, Canada and India
approved emergency contraception for nonprescription sales. [Footnote 5: Morning After, The Toronto
Sun, April 24, 2005 ; A Nod for Counter Sales of Emergency Contraceptives, The Hindu, Sept. 1, 2005.
Attached hereto at Ex. 3.]
<39: 1.2.1>After Duramed requested OTC status for Plan B, FDA jointly convened its Nonprescription
Drugs Advisory Committee and FDA's Reproductive Health Drugs Advisory Committee to review the
application. In December 2003, after reviewing extensive scientific evidence, the committees voted, by a
margin of 28 to 0, that Plan B is safe. The committees voted, by a margin of 23 to 4, that Plan B should be
made available OTC.6 [Footnote 6: Hearing Tr. at 349, 395.]
<6: 1.2.1>Reflecting strong public support for the switch to OTC status, editorials from across the
country have urged FDA to accept the committees' recommendation. The New York Times called the
committee vote "A Public Health Victory," The Pittsburg Post-Gazette called it "welcome news," and
urged that "FDA would be wise to accept the [committees'] recommendation and authorize sale as soon as
possible." The Denver Post "strongly support(ed] the recommendation." The Miami-Herald stated that,
"[t]he two panels' lopsided vote for Plan B is encouraging. In the past, the FDA has followed its experts'
advice, It should do so now." The Buffalo News urged that NDA 2l-045 "deserve[d] quick approval."
[Footnote 7: Editorial, A Public Health Victory, N. Y. Times, Dec. 18, 2003; Editorial, The FDA's
Chance to Improve Contraception, Pittsburgh Post-Gazette, Dec. 21, 2003; Editorial, OK 'Morning After
Pill, ' The Denver Post Dec. 18, 2003; Editorial, Morning-After Pill Gets a Boost, The Miami-Herald,
Dec. 18, 2003; Editorial, The Morning After Pill /Plan B Contraceptive Deserves Approval by FDA -And
Quickly, The Buffalo News, Dec. 29,2003. These articles are attached hereto at Ex. 4.]
Notwithstanding the findings and recommendations of the two expert committees, by letter dated May 6,
2004; Dr. Steven Galson, then acting director of the FDA Center for Drug Evaluation and Research
("CDER"'), informed Duramed that Supplement 011 was not approvable. In an interview, Dr. Galson
acknowledged that his action was not the norm, and that in refusing to allow Plan B to be sold OTC, he
rejected not only the judgment of a joint advisory panel, but also the recommendations of his own staff.
[Footnote 8: Harris, Gardiner, Morning-After-Pill Ruling Defies Norm, N.Y. Times, May 8, 2004, at A13.
Attached hereto at Ex 5.] A draft report by the Government Accountability Office agrees that the
decision was highly unusual, that it was made with atypical involvement from senior agency officials, and
that it was made months before it was formally announced. [Footnote 9: Kaufman, Marc, Decision on
Plan B Called Highly Unusual, The Washington Post, Oct. 13, 2005, at A09 (reporting on draft GAO
report). Attached hereto at Ex. 6.]
In its May 2004 letter, FDA stated that there was inadequate data to support that Plan B can be used
safely by women under the age of 16 for emergency contraception without the supervision of a licensed
practitioner. FDA did not cite any studies or data to support a concern that use of Plan B by younger
adolescents is unsafe. Indeed, the advisory committees discussed and analyzed issues relating to OTC use
of Plan B by adolescents, and did not vote to recommend against OTC use for that population. [Footnote
10: See, e.g., Hearing Tr. at 349-75.] In recent studies, access to emergency contraception did not lead
teenagers to increase sexually risky behavior. [Footnote 11: See Tina R. Raine, et al., Direct Access to
Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STls, JAMA
293:54-62 (2005) (study of 2,117 young women ages 15 to 24 concluded that providing young women
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with access to emergency contraception did not lead them teenage in more risky sexual behavior);
Cynthia C. Harper, et al., The Effect of Increased Access to Emergency Contraception Among Young
Adolescents, 106 Obstetrics & Gynecology 483-491 (2005) ("The Effect of Increased Access ") (finding
that young adolescents with improved access to emergency contraception used the method more
frequently when needed, but did not compromise their use of routine contraception or increase risky
sexual behavior). These studies are attached hereto at Ex. 7.] There was also no increase in sexually
transmitted diseases or decrease in the use of other forms of contraception. [Footnote 12: The Effect of
Increased Access, at 489.]
<7: 1.2>FDA's May 2004 letter also suggested that Duramed could address the Agency's concerns by
proposing a dual label for Plan B, with a prescription label for women under 16 and an OTC label for
women 16 and older. On July 6, 2004, Duramed submitted to FDA a complete response to the Agency's
May 6 not-approvable letter. Following FDA's suggestion, Duramed proposed OTC status only for the
subpopulation of women age 16 or older while maintaining Rx status for women age 15 and younger.
Duramed also proposed that both the Rx version and the OTC version of Plan B be marketed in the same
packaging (with a place for prescription-related information to be added when the product is dispensed
pursuant to a prescription). On August 11, 2004, FDA accepted the submission as a complete response to
the May 2004 Not Approvable letter. The PDUFA action date for the resubmission was January 20,2005.
FDA informed Duramed on that date that the Agency would not then be taking an action on the
supplement.
FDA's failure to take a final action on NDA 21-045 led Senators Hillary Rodham Clinton (D-NY) and
Patty Murray (D-Wash.) to block a full Senate vote on Lester Crawford's nomination to be commissioner
of FDA. In July 2005, the Senators agreed to lift their holds after Health and Human Services ("HHS ")
Secretary Mike Leavitt wrote, in a letter to Senator Mike Enzi (R-Wyo.), who chairs the Senate
Committee on Health, Education, Labor and Pensions, that FDA would act on Duramed's application by
September 1, 2005.
By letter dated August 26, 2005, FDA informed Duramed that CDER had completed its review of
Duramed's application and found that "the available scientific data are sufficient to support the safe use of
Plan B as an OTC product" for women who are 17 years and older. Letter from L. Crawford to Duramed
Research, Inc. of 8/26/05.
Notwithstanding this undisputed scientific finding and the fact that Plan B is also effective in OTC use
under the same directions for use that apply when the drug is dispensed pursuant to a prescription, FDA
refused to take final action on Duramed's supplement, and indefinitely delayed final action, FDA stated
that the supplement presented the agency with the question of whether and how to market the same active
ingredient to different populations for Rx and OTC use, and indicated that it would seek comments on
whether to initiate rulemaking to resolve those issues.
<8: 1.2>One FDA official and a consulting member of an FDA advisory committee have publicly
resigned in protest over the August 26 Plan B decision. Susan F. Wood, the Assistant Commissioner for
Women's Health and Director of the Agency's Office of Women's Health, resigned shortly after the
August 26 decision was announced. She stated that FDA's decision was contrary to the scientific evidence
and resulted from unwarranted interference in agency decision-making. "I can no longer serve as staff
when scientific and clinical evidence, fully evaluated and recommended for approval by the professional
staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues. [Footnote 13:
Marc Kaufman, FDA Official Quits Over Delay on Plan B, The Washington Post, Sept. 1, 2005, A08.
Attached hereto at Ex. 8. ] In early October, Frank Davidoff, a member of FDA's Nonprescription Drugs
Advisory Committee when it voted to recommend approval of Plan B for nonprescription sales in 2003,
also resigned his current consulting position with that committee in protest. He stated: "There wasn't any
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observable scientific or procedural reason for [FDA] to first decline and then further delay the decision. I
had to make the inference this was a decision that was made on the basis of political pressure, and it
seemed to me that was unacceptable." [Footnote 14: FDA Advisor Resigns Over Plan B Handling, The
Associated Press, Oct. 6, 2005. Attached hereto at Ex. 9.]
The relevant scientific and medical communities have .almost uniformly concurred with Dr. Wood's and
Dr. Davidoff's assessment. They have heavily criticized FDA's continued refusal to approve OTC status
for Plan B. An editorial in The New England Journal of Medicine was typical of this response: "[T]he
agency has previously resisted political pressure to reflect a particular social policy or ideology. The
recent actions of FDA leadership have . . . squandered the public trust and tarnished the agency's image."
Allastair J.J. Wood, et al., A Sad Day for Science at the FDA, 353:12 N. Engl. J. Med. 1196, 1198.
Attached hereto as Ex. 10.
On October 7, 2005, a bipartisan group of 62 U.S. legislators wrote to FDA to urge acting Commissioner
Andrew van Eschenbach to approve Plan B for OTC use. The legislators argued that, "[b]y further
delaying the FDA's decision to expand access to emergency contraception, [FDA is] seriously hindering
efforts to reduce abortions across the U.S." and it called on Dr. von Eschenbach to approve Plan B
"without further delay." The legislators continued, "[w]e find it contradictory and disconcerting that the
FDA's concerns are a direct result of the agency's own recommendations last May . . . . We believe this
new delay does not truly reflect valid scientific or regulatory concerns" [Footnote 15: 15 U.S.
Lawmakers Call for Morning-after Pill Approval, Reuters, Oct. 11, 2005. Attached hereto at Ex. 11.]
DISCUSSION
FDA's Notice seeks comment on the following questions:
1-A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously marketed in both a prescription drug product and an
OTC drug product?
I.B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the FDCA?
l.C. If so, would a rulemaking on this issue help dispel that confusion?
2.A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
2.B. If it could, would it be able to do so as a practical matter and, if so, how'?
3.A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product,
may the different products be legally sold in the same package?
3.B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
70 Fed. Reg. 52,050, 50,251 (Sept. 1, 2005). Duramed takes up each of these questions in turn below.
<9: 3.8.4>I. FDA'S INTERPRETATION OF SECTION 503(b) HAS NOT CREATED CONFUSION,
AND THERE IS NO NEED FOR ANY RULEMAKING IN ORDER TO APPROVE NDA 21-04S/S011.
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FDA need not, and should not, initiate a rulemaking to codify its interpretation of section 503(b)
regarding when an active ingredient can be marketed simultaneously in both an Rx drug product and an
OTC drug product.
As FDA acknowledges in the Notice, it has on a number of occasions permitted simultaneous Rx and
OTC marketing of a product. Were FDA's interpretation of section 503(b) really in need of clarification,
that need would have arisen well before now. The fact that the issue has not previously been raised is
strong evidence that there is no need for rulemaking regarding FDA's interpretation of section 503(b).
Moreover, the issue presently before FDA is whether this drug product, Plan B, can simultaneously be
marketed as both an Rx and an OTC drug product. Resolution of that issue need not, and ultimately does
not, implicate FDA's long-standing interpretation of section 503(b).
<10: 3.9.2>A. UNDER THE FDCA AND FDA'S EXISTING REGULATIONS, PLAN B CAN
PROPERLY BE AN OTC DRUG FOR ONE PATIENT SUBPOPULATION
Generally, new drug products that are indicated for different patient populations are different "new
drugs." Where new drug products are different, one may be an Rx drug product, and the other an OTC
drug product, without creating any problem under the FDCA or FDA's regulations.
The Manual of Policies and Procedures of the Center for Drug Evaluation and Research ("MAPP")
expressly contemplates that an Rx version and an OTC version of a drug product may differ only in the
population for which they are indicated:
Initial Marketing o-f a Drug Product OTC. This category of product could be one of two types: (1) OTC
marketing of a product that was never previously marketed as a prescription drug product or (2) OTC
marketing of a product in a strength, dose, route of administration, duration of use, population, indication,
or dosage form different from ones previously approved for prescription use.
MAPP 60205 at 2 (Jan. 15, 1997) (boldface in original) (emphases added), available at
http://www.fda.gov/cder/mapp/6020-5.pdf. [Footnote 16: The universe of OTC drug products consists of
(i) those initially marketed OTC, and (ii) those switched from Rx to OTC status. As a matter of
terminology, the term "Rx to OTC switch" "refers only to OTC marketing of a product that was once a
prescription drug product for the same indication, strength, dose, duration of use, dosage form,
population, and route of administration." MAPP 6020.5 at 2. The proposed Plan B subpopulation switch
is an "Rx to OTC switch" with respect to the population of women age 16 and over; for that
subpopulation, the drug product previously was available only as an Rx product, but would now be
available OTC.] The use of the disjunctive "or" in the quoted passage makes clear that the passage
expressly contemplates "OTC marketing in a . . . population . . . different from ones previously approved
for prescription use," id.
<11: 3.9.2>There is no legally relevant distinction between the proposed subpopulation switch of Plan B
and the scenario described in MAPP 6020.5. As applied to Plan B, the exact analogy would be a scenario
in which Plan B had previously been approved only as an Rx drug for women age 15 and younger, and
were now also to be approved as an OTC drug for women age 16 or over. In that scenario, the proposed
OTC population would be "different from [the one] previously approved for prescription use." MAPP
6020.5 at 2.
It should make absolutely no difference, however, that Plan B previously has been approved as an Rx
drug for women age 16 or over (as well as for women age 15 and younger), In both the scenario described
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in MAPP 6020.5 and in the proposed scenario for Plan B, after approval of the drug for the specified OTC
subpopulation, the drug would simultaneously be approved as an Rx drug for one subpopulation and as an
OTC drug for another. Nothing in the discussion in MAPP 6020.5 suggests that, upon the approval of the
OTC status for the new patient subpopulation, the Rx status for the remaining patient subpopulation
would be withdrawn. Thus, MAPP 6020.5 demonstrates that there is no FDA policy that precludes the
approval of a drug for simultaneous marketing as an Rx drug for one patient subpopulation and as an
OTC drug for another.
<12: 3.3.3>The newness of a drug may arise from the newness of the "use " of the drug. 21 C.F.R. §
310.3(h)(4) (2005). Intended uses of a drug in different patient subpopulations constitute different uses of
the drug, and thus create different new drugs, within the meaning of FDCA §§ 201(p) and 505(a), 21
U.S.C. §§ 321.(p), 355(a). The reason why a supplement is required for an additional indication for an
approved new drug is that the additional indication constitutes a new use of the drug and therefore creates
a different new drug. A manufacturer of an approved drug that promotes its product for a use different
from or additional to the approved use(s) is subject to a charge of violating FDCA §§301(d), 21 U.S.C. §
331(d), as well as to a misbranding charge under FDCA § 502(f)(1), 21 U.S.C. § 352(f)(1). See Decision
in Washington Legal Foundation v. Henney, 65 Fed. Reg. 14,286-01, 14,286-01 (Mar. 16, 2000) ("an
approved new drug that is marketed for a 'new use' becomes an unapproved new drug with respect to that
use").
FDA recognizes that persons age 15 and younger constitute a patient population ("the pediatric age
group") distinct from patient populations consisting of persons age 16 or over. See 21 C.F.R. §
201.57(f)(9)(i) (2005). Generally, separate investigations are necessary to support an indication for that
population, as distinct from an indication for an adult population. See generally, FDCA $ 505A, 21
U.S.C. § 355a; 21 C.F.R. § 201.57(f}(ii) (2005).
<13: 6.3.1>Thus, for example, if a drug is indicated only for an adult population, but is promoted by its
manufacturer for a pediatric population, the manufacturer would be subject to a charge under section
301(d) as well as to a charge under section 502(f)(1), The availability of a new-drug charge in this type of
situation demonstrates conclusively that a drug intended for one patient population is a different new drug
from the otherwise identical drug intended for a different patient population. In the language of section
310.3(h)(4), the difference between the intended patient population creates a different "use" of the drug -
even though, in all other respects, the drug's physical qualities and its conditions of use (e.g., the medica1
condition it is intended to treat) remain the same. [Footnote 17: In the terms of FDCA § 201(p), 21
U.S.C. $ 321(p), the difference in intended patient population constitutes a difference in "the conditions
prescribed, recommended, or suggested" for the drug. ]
Therefore, where intended patient populations are sufficiently distinct that FDA has concluded, on
medical grounds, that one and the same product (i.e., same ingredients, dosage form, route of
administration, strength, etc.) should be available OTC for one subpopulation of patients but only Rx for a
second subpopulation, the uses of that product for the different subpopulations are different; and therefore
the product, as intended for the different subpopulations, is, technically, two different new drugs.
[Footnote 18: Patient populations can be differentiated on a variety of bases - including disease state,
experience with other drugs, and gender, as well as age. ]
<14: 3.9.2>"Sometimes the dose of a product to be marketed OTC may be lower than the previous
prescription dose, or the proposed use may differ from the prescription use." FDA, Questions and
Answers[:] Over-the-Counter Drug Products-Public Hearing June 28 and 29, 2000, at 3, available at
http://www.fda.gov/cder/meeting/otcqa-600.htm (emphasis added). The FDA Questions and Answers
expressly contemplate approval of a drug product for simultaneous marketing as an Rx drug for one use
and as an OTC drug for another. As just explained, uses by different patient populations are different
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uses.
The permissibility under the FDCA of approving the same drug product as Rx for one patient population
and as OTC for another is valuable and important for protection of the public health. Such a pair of
approvals enables the Agency to titrate the degree of intervention by healthcare professionals in patients'
access to the drug product. Where FDA appropriately determines that a particular drug product can be
safely, effectively, and appropriately used by one patient population with access QTC, but that another
patient population needs the supervision of a physician, it would be inappropriate to make the drug
product either entirely OTC (in which case the group for whom a prescription requirement is warranted
would be put at risk) or entirely Rx (in which case the group for whom a prescription requirement is
unwarranted would be subjected to unnecessary burdens and expense and, in this case, may experience
unnecessary delay in obtaining the product, whose effectiveness diminishes with delay before use).
<15: 3.9.3>Further support for the permissibility under the FDCA and FDA's regulations of simultaneous
dispensing to different patient populations of Rx and OTC versions of a drug is provided by FDA policy
with respect to veterinary drugs. With respect to the Rx legend, veterinary drugs are subject to provisions
very similar to § 503(b)(4). Compare FDCA § 503(b)(4), 21 U.S.C. § 353(b)(4) with FDCA § 503(f)(4),
21 U.S.C. § 353(f)(4). CVM Program Policy & Procedures Manual Guide 1240.2220 § 3.d (Mar. 9,
2000), available at http://www.fda.gov/cvm/Policy-proced/2220.pdf, states:
In the past, the same products used in varying routes of administration, dosage forms, and in varying
species of animals may have been labeled prescription in one instance and non-prescription for other uses.
The primary question is whether adequate directions for use can be written to assure safe and effective
use. If an average food animal producer can safely and effectively administer a product, but a companion
animal owner, regardless of label directions, cannot administer it safely and effectively, then the
prescription status of the product must be different relative to these intended uses. If directions can be
written for use for a particular route of administration (IV, IP, etc.) for one animal species but not for
another, it is not inconsistent to grant OTC status for the one use and require the Rx legend for the other.
Id. This passage plainly contemplates that identical versions of a veterinary drug may be labeled in one
instance (for one population) Rx and in another instance (for another population) OTC.
In sum, the proposed subpopulation switch of Plan B is consistent with existing written FDA policy. No
further policy development is needed to support approval of the proposed subpopulation switch.
<16: 4.4.1>B. FDA'S INTERPRETATION SECTION 503(b) HAS NOT CAUSED ANY CONFUSION.
There has been no history of confusion regarding FDA's interpretation of section 503(b)(1i) of the FDCA
as permitting simultaneous Rx and OTC marketing when some meaningful difference exists that makes
the drug safe and effective for one patient population only under the supervision of a licensed practitioner
but safe and effective for another patient population without such supervision.
There can be no genuine dispute that FDA has the authority to allow simultaneous marketing of the same
active ingredient in Rx products and OTC products. In fact, approval of otherwise Rx drug products for
OTC use in an appropriate subpopulation is not a novel concept. Whether a subpopulation is defined by a
disease state (e.g., mild, moderate, severe), by prior experience with a drug (e.g.,, failed on first-line
therapy), by gender, or by age (e.g., pediatric, geriatric) varies with particular products, but the principle
is the same: different subpopulations for whom a drug is indicated create different "new drugs," for which
separate approval is needed and which separately may be either Rx or OTC.
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Although FDA has repeatedly found conditions under which an active ingredient may be marketed
simultaneously in both a prescription drug product and an OTC drug product, and has presumably on
occasion refused to find that such conditions exist, Duramed has been unable to locate any challenges to
the interpretation of section 503(b)(f) that FDA utilizes to make such determinations. A review of the case
law reveals that there is no published opinion addressing purported confusion regarding FDA's
interpretation. Similarly, a review of the academic literature, including a review of the journals specific to
issues relating to FDA and food and drug law, reveals that there has been no scholarly work identifying,
or seeking to resolve, any confusion as to FDA's interpretation. In sum, neither the private nor public
sector has been confused by FDA 's interpretation.
<17: 5.4.1>C. BECAUSE THERE IS NO CONFUSION REGARDING FDA'S INTERPRETATION,
RULEMAKING IS UNWARRANTED.
Because there is no confusion regarding FDA's interpretation of section 503(b), there is no need for
rulemaking to clarify FDA's interpretation.
Even if there were some circumstances in which confusion might somehow result from FDA's
interpretation of section 503(b), there is no confusion regarding the application of FDA's interpretation to
NDA 2l-04S/S011. Thus, no notice-and-comment rulemaking or guidance document is legally required or
factually warranted in the circumstances here. The approval Duramed seeks from FDA is specific to NDA
2l-045/S011 as amended, and does not raise broad issues potentially affecting other products.
If FDA is concerned that it has little prior experience with such use of an age restriction or its reflection in
labels and labeling, the appropriate response is not to initiate rulemaking now. Instead, it is reasonable
and appropriate for the agency to proceed case by case to accumulate experience before embodying a
particular approach in a rule adopted in a notice-and-comment proceeding. See, e.g., SEC V. Chenery
Corp., 332 US. 194, 202-03 (1947) (agency has discretion to proceed case by case or by notice and
comment).
Since there is currently no court-created deadline, a rulemaking seeking to clarify FDA's interpretation of
section 503(b), if initiated before approval of NDA 21-245/S011, could potentially delay such approval
by years. FDA should not delay a decision on the pending supplement in order to conduct rulemaking to
address concern over the clarity of its interpretation in some hypothetical future scenario. The delay that
would necessarily accompany rulemaking in this instance would be particularly unjustified because it
would deny women age 17 and over prompt and convenient access to a drug that FDA has already found
is safe and effective for them when available OTC. Such delay would be flatly contrary to FDCA §
903(b)(1), 21 U.S.C. § 393(b)(1).
<18: 6.3.4>II. FDA CAN ENFORCE LIMITED SALE OF AN OTC PRODUCT TO A PARTICULAR
SUBPOPULATION.
As the Notice highlights, there is nothing novel about an active ingredient that is marketed simultaneously
in both an Rx drug product and an OTC drug product. FDA has repeatedly approved such simultaneous
use where there is, as FDA states in its Notice, "some meaningful difference . . . between the two that
makes the prescription product safe only under the supervision of a licensed practitioner." 70 Fed. Reg. at
52051. That the meaningful difference is in the population taking the drug, and not in the active
ingredient, itself, has no impact on FDA's legal and practical ability to enforce the prescription
requirement while permitting OTC sales of a drug with the same active ingredient.
<19: 6.3.1>A. AS A MATTER OF LAW, FDA CAN ENFORCE LIMITATION OF AN OTC
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PRODUCT TO A PARTICULAR SUBPOPULATION THROUGH ENFORCEMENT OF SECTION
503(B)(1)(B).
Just as it has the legal authority to enforce a prescription limitation where the limitation applies to the
entire population, FDA has the legal authority to enforce the prescription limitation of Plan B as to a
subpopulation (i.e., women 15 and younger).
Section 503(b)(1)(B) of the FDCA provides:
A drug intended for use by man which . . . is limited by an approved application under section 505 to use
under the professional supervision of a practitioner licensed by law to administer such drug; shall be
dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or
(ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the
pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the
prescriber either in the original prescription or by oral order which is reduced promptly to writing and
filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be
deemed to be an act which results in the drug being misbranded while held for sale.
21 U.S.C. § 353(b)(1)(B) (emphasis added).
In turn, section 301(k) provides that the following is a prohibited act: "The . . . doing of any other act with
respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether
or not the first sale) after shipment in interstate commerce and results in such article being adulterated or
misbranded." 21 U.S.C. § 331(k).
Injunctive relief for violation of section 301(k) is available under FDCA § 302.21 U.S.C. § 332. Criminal
penalties for committing a prohibited act under section 301(k) are available under FDCA § 303(a), 21
U.S.C. § 333(a).
Reading these three sections together, "the conclusion is inescapable . . . that one dispensing drugs . . .
contrary to the provisions of Sec. 353(b)(1) shall be guilty of, and subject to the punishment provided by
law for, an act of misbranding." United States v. Carlisle, 234 F.2d 196,199 (5th Cir. 1956). Thus, if FDA
approves Duramed's supplement to NDA 2l-045/S011, permitting OTC sale for those age 16 and over and
requiring a prescription for sale to those under age 16, then selling to someone age 15 or younger without
a prescription would constitute a prohibited act under section 301(k), for which civil and criminal
remedies are available under the FDCA.
<20: 7.4.1, 7.4.4>B. FDA HAS EXTENSIVE EXPERIENCE IN ENFORCING PRESCRIPTION
REQUIREMENTS.
The application of age restrictions to certain products is prevalent throughout our society. With respect to
Plan B, the restriction could be enforced by requiring pharmacies to keep the drug behind the counter and
dispense it only upon presentation of (i) a prescription or (ii) identification showing that the consumer is
age 16 or over. These requirements and the age restriction can be enforced through a variety of
mechanisms, all of which FDA has readily at its disposal and/or can employ in cooperation with state and
local governments.
<21: 7.4.2>First, in testimony before the Committee on Government Reform on September 13, 2005,
Robert J. Meyer, M.D., Director, Office of Drug Evaluation II ("'Meyer 'Testimony"), outlined many of
the enforcement mechanisms FDA currently employs to curb prescription drug abuse. [Footnote 19: Dr.
Meyer's testimony is attached hereto at Ex. 12. ] FDA could use these mechanisms to enforce a
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prescription requirement for women under age 16. For example, as it does in other matters, FDA can
undertake joint investigative efforts with the Drug Enforcement Administration.
<22: 7.4.3>Second, FDA is authorized by FDCA § 704,21 U.S.C. § 374, to conduct inspections of
establishments that are subject to the requirements of the FDCA, which include pharmacies selling drug
products. Anyone who refuses to permit such an inspection is subject to criminal penalties under FDCA §
301(f), 21 U.S.C. §331(f), and § 303(a), 21 U.S.C. § 333(a). Under FDCA § 702,21 U.S.C. § 372, FDA
may conduct examinations and investigations, through officers and employees of the Department of
Health and Human Services or through any health, food., or drug officer or employee of a state and local
government, duly commissioned by the Secretary of Health and Human Services as an officer of the
Department. Through use of its own, or state, investigators, FDA can conduct random, unannounced
inspections of pharmacies or stores, to ensure that they are enforcing the prescription limitation of Plan B
for women younger than age 15.
<23: 7.4.5>Third, FDA can deter persons from violating the subpopulation Rx requirement by
aggressively pursuing criminal actions against known violators. FDA can use a number of means to
pursue such enforcement, Cases can be developed, through FDA's network of field offices, reviewed by
FDA headquarters, and then submitted to the Office of Consumer Litigation ("OCL") in the Department
of Justice. OCL determines whether to pursue criminal or civil remedies, if any. FDA can also refer cases
through the Office-of Criminal Investigations ("OCI"). OCI can refer cases directly to United States
Attorneys' Offices.
<24: 7.4.2>Fourth, FDCA § 909,21 U.S.C. § 399, authorizes FDA to make grants to States for the
purpose of conducting examinations and investigations. FDA can allocate grants to state and local
governments to aid them in their awn enforcement of such a restriction. State drug inspectors, in
connection with local law enforcement, are involved in enforcing prescription requirements. President
Bush's 2005 National Drug Control Strategy recognizes that state prescription drug monitoring programs
are highly effective in curbing prescription drug abuse. [Footnote 20: The President's National Drug
Control Strategy, The White House, 36-37 (2005). Attached hereto at Ex. 13. ]
<25: 7.3.1.2>Fifth, FDA has the inherent authority to publicize the importance of strict adherence to
prescription requirements, and could undertake a public education campaign to ensure that women under
the age of 16 are aware of their need to obtain a prescription to buy Plan B. See also FDCA § 705, 21
U.S.C. § 375. For example, as Dr. Meyers testified, FDA has recently partnered in launching a
"prescription drug abuse prevention education effort, with the primary goal of preventing and reducing
the abuse of prescription drugs . . . by teens and young adults." Meyer Testimony at 4. FDA could launch
a similar educational campaign regarding Plan B.
<26: 7.3.2>Sixth, FDA can also monitor the advertising and promotion of Plan B through its Division of
Drug Marketing, Advertising, and Communications, which is responsible for regulating prescription drug
advertising and promotion.
<27: 7.4.6>Seventh, FDA can monitor its enforcement success by making annual reports to the
Department of Health and Human Services concerning the methods and effectiveness of enforcement
efforts. For one example, the Substance Abuse and Mental Health Services Administration ("SAMHSA"),
part of HHS, conducts an annual National Survey of Drug Use and Health on a random sample of U.S.
households. This survey seeks to determine the prevalence of non-medical use of prescription drugs. FDA
can work with SAMHSA to randomly sample, as part of its annual survey, the number of women under
16 who use Plan B without a prescription, report its findings, and thereby monitor the effectiveness of its
enforcement efforts over time.
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<28: 7.3.1.1, 7.3.1.2>Duramed will aid FDA's efforts through its proposed Convenient Access,
Responsible Education ("CARE") program. Under the program, distribution of Plan B will be limited to
retail operations with pharmacy services and clinics. The product packaging for Plan B will also include a
24-hour toll-free number and a supplementary patient leaflet that will describe available contraceptive
methods, including abstinence, and information on sexually transmitted diseases. The program will also
include educational and monitoring programs for physicians and pharmacists that clearly set forth, and
evaluate the effectiveness of, the prescription age restriction.
<29: 8.3.1>III. RX AND OTC DRUG PRODUCTS CAN LAWFULLY BE SOLD IN THE SAME
PACKAGING.
A. FDCA § 503 CAN BE SATISFIED BY MARKETING THE Rx AND OTC VERSIONS OF PLAN B
IN THE SAME INITIAL PACKAGING.
Under the FDCA and current FDA regulations, Rx and OTC products can lawfully be sold in the same
packaging. Specifically, with respect to packaging of Plan B, FDCA § 503 can be satisfied by ensuring
that all packages contain (i) adequate information and directions to ensure safe, effective, and appropriate
OTC use, (ii) the legend "Rx only for women under age 17," and (iii) appropriate space for the traditional
Rx label, to be affixed by a pharmacist when dispensing the product pursuant to a prescription.
Issues relating to the label and labeling of Plan B have already been reviewed and addressed by the
Reproductive Health and OTC Divisions of CDER during their review of Duramed's July 2004
submission. Appropriate labeling, including that on the tamper-evident seal, has been created and
submitted to FDA.
<30: 8.3.1>1. The Label.
a. Compliance with General Requirements Applicable to the Label.
Plan B, when dispensed as an Rx drug, would need to comply, and would comply, with all requirements
applicable to the label of an Rx drug and, when dispensed as an OTC drug, need to comply, and would
comply, with all requirements applicable to an OTC drug. It would also need to comply, and would
comply, with all requirements applicable to it during the period prior to dispensing.
It is proposed that Plan B have a printed label that includes all mandatory information for an OTC
product. The proposed label and outer packaging comply with all the affirmative requirements applicable
to OTC labels under FDCA §§ 502(b), 502(e)(1)(A), 502(f), 502(g), 21 U.S.C. § 352(b); 352(e)(1)(A),
352(f), 352(g); 21 C.F.R. §§ 201.1, 201.5, 201.10, 201.15, 201.17, 201.60- 62 (2005).
<31: 8.3.1>In addition, when Plan B is dispensed pursuant to a prescription, its label would be subject to
all the requirements applicable to labels of Rx drugs under FDCA §§ 502(b), 502(e)(1)(B), 502(g), 21
U.S.C. §§ 352(b), 352(e)(1l)(B), 352(g); 21 C.F.R. §§ 201.50, 201.51, 201.100(b) (2005).
Even though Plan B, as an OTC product, would bear adequate directions for use by consumers who, in
accordance with the approved labeling, may buy the product without a prescription, it would not {in legal
contemplation) bear adequate directions for use by patients who, in accordance with the approved
labeling, may buy the product only with a prescription. [Footnote 21: The legal theory justifying
prescription status as to those patients is that adequate directions for use by them cannot be written. ]
Therefore, when dispensed to a patient who may obtain the-product only pursuant to a prescription. Plan
B must comply, and would comply, with all the conditions, set forth in 21 C.F.R. § 201.100 (2005), for
exemption from the requirement of adequate directions for use by the prescription population, FDCA §
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502(f)(1), 21 U.S.C. § 352(f)(i).
<32: 8.3.1>There is no obstacle to simultaneous compliance with all these requirements. Indeed, because
the product information, including all directions for use are exactly the same for the Rx and the OTC
users of Plan B, the presence of the OTC information and directions on the packages dispensed to Rx
users would tend to enhance their safe, effective, and appropriate use of the product. Neither
subpopulation of patients would be in any way adversely affected by the presence on the package of any
information placed there in order to comply with a regulatory requirement for the protection of the other
subpopulation.
FDCA § 503(b)(2), 21 U.S.C. § 353(b)(2), exempts an Rx drug from many of the requirements of §
502,21 U.S.C. § 352, if its label contains (i) the name and address of the dispenser; (ii) the serial number
and date of the prescription or its filing; (iii) the name of the prescriber, (iv) if stated in the prescription,
the name of the patient; and (v) the directions for use and cautionary statements, if any, contained in such
prescription. The information required by section 503(b)(2) would appear on the Rx label attached to the
package by the pharmacist when dispensing the product pursuant to a prescription.
<33: 8.3.1>b. Compliance with Section 503(b)(4).
FDCA § 503(b)(4) provides:
(A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to
dispensing the label of the drug fails to bear, at a minimum, the symbol "Rx only".
(B) A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to
dispensing the label of the drug bears the symbol described in subparagraph (A).
21 U.S.C. § 353(b)(4).
Whether a drug product is subject to section 503(b)(4)(A) or 503(b)(4)(B) depends entirely on whether it
falls under paragraph (1) of section 503(b). Under the proposed subpopulation switch, Plan B would
remain an Rx product for women under age 16. Therefore, it would remain "'[a] drug that is subject to
paragraph (1)" of section 503(b). Consequently, at all times, it would remain subject to section
503(b)(4)(A), and would not be subject to section 503(b)(4)(B), which applies only to drug products that
are not subject to any prescription requirement under section 503(b)(1) at all. Even the units of Plan B
ultimately dispensed OTC to women age 16 or over would be subject to a prescription restriction under
section 503(b)(1) against their being dispensed OTC to women under age 15, and so would be subject to
section 503(b)(4)(A,) rather than to section 503(b)(4)(B).
Duramed proposes that Plan B comply with section 503(b)(4)(A) by bearing on its label the legend: "Rx
only for women under age 15 and younger." Section 503(6)(4)(A) requires that "the symbol 'Rx only"'
appear on Plan B's label. The symbol "Rx only" would appear on the label as part of the statement "Rx
only for women age 15 and younger," Nothing in section 503(b)(4)(A) precludes the appearance of the
symbol on a label as part of a truthful and non-misleading statement of the prescription limitation
applicable to the labeled product under its NDA. Indeed, the expression "at a minimum" in section
503(b)(4)(A) expressly contemplates that the words "Rx only" may appear with other words on the label.
The proposed Rx legend would comply literally with the text of section S03(b)(4)(A). It also would fully
serve the purpose of section 503(b)(4), which is to make clear to pharmacists and the public when a drug
product is to be dispensed OTC or only by prescription.
<34: 8.3.1>2. Labeling.
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 67
a. OTC Labeling.
The Plan B package would also need to contain, and would contain, labeling that complies with the
labeling requirements applicable to OTC products, 21 C.F.R. § 201.66 (2003).
b. Rx Labeling.
There would also need to be Rx labeling with respect to the class of patients to whom the product may be
dispensed only pursuant to a prescription. See 21 C.F.R. §§ 201.50, 201.56; 201.100(c), 201.100(e)
(2005). Thus, it would be necessary to revise the current Rx labeling. Plan B would comply with these
requirements.
<35: 8.3.2>c. NDC Number.
There would not be separate NDC numbers for the (Rx and OTC) versions of Plan B. There is no need for
separate numbers because all purposes of the NDC system would be fully served here by a single
number.
<36: 9.1.1>B. IN LIMITED CIRCUMSTANCES NOT APPLICABLE TO PLAN B, TWO PRODUCTS
COULD NOT BE SOLD IN THE SAME PACKAGING.
It would be inappropriate to sell two products in the same packaging if different doses, different strengths,
or different directions for use were needed for the safe and effective use of the OTC produce as compared
to the safe and effective use of the prescription product. None of these circumstances, however, applies to
the marketing and sale of Plan B.
CONCLUSIONS
For the foregoing reasons, (i) FDA should not initiate rulemaking with regard to its interpretation of
section 503 of the FDCA; (ii) FDA has the legal authority and practical ability to enforce an age-related
prescription limitation applicable to Plan B; and (iii) FDA can permit the marketing of the Rx and OTC
versions of Plan B in the same packaging.
FDA has determined that Plan B is safe and effective for OTC use in women age 17 and older. Therefore,
FDA should give final approval to NDA 21-045/S011 without further delay.
Respectfully submitted,
Richard M. Cooper
Ana C. Reyes
WILLIAMS & CONNOLLY LLP
725 12th Street, NW
Washington, DC 20005
(202) 434-5000
Attorneys for Duramed Pharmaceuticals, Inc. and Duramed Research, Inc.
November l, 2005
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LAW OFFICES
WILLOWS & CONNOLLY LLP
725 TWELFTH STREET, NW.
WASHINGTON, D. C. 20005-5901
FAX (202) 434-5029
November 1, 2005
BY HAND DELIVERY
Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No. 2005N-0345/RIN No. 0910-AF72
Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in
Both a Prescription Drug Product and an Over-the-Counter Drug Product
Dear Sir or Madam:
Enclosed please find one original and three copies of comments, and exhibits
attached thereto, submitted by Duramed Pharmaceuticals, Inc. and Duramed Research, Inc. in response to
the above-referenced Advance Notice of Proposed Rulemaking.
Sincerely,
Ana c. Reyes
Enclosures
COMMENT NUMBER - 2005N-0345-C443
2005N-0345-C443 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: National Association of Boards of Pharmacy
2005N-0345-C443 - TEXT
November 1, 2005
Division of Dockets Management
Food and Drug Administration
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5630 Fishers Ln, Room 1061
Rockville, MD 20852
Re: Drug Approvals; Circumstances Under Which an Active Ingredient May be Simultaneously
Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product [Docket No.
2005N-0345]
The purpose of this correspondence is to provide the comments of the National Association of Boards of
Pharmacy (NABP) to the United States Food and Drug Administration (FDA) in response to its request
for public comments on whether to initiate a rulemaking to codify its interpretation of section 503(b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.) regarding when an active ingredient
may be simultaneously marketed in both a prescription drug product and an over-the-counter (OTC) drug
product.
As you may know, NABP, founded in 1904, represents all of the pharmacy regulatory and licensing
jurisdictions in the US, Guam, Puerto Rico, the Virgin Islands, eight provinces of Canada, two states in
Australia, New Zealand, and South Africa. NABP's purpose is to serve as the independent, international,
and impartial association that assists its member boards and jurisdictions in developing, implementing,
and enforcing uniform standards for the purpose of protecting the public health.
<1: 3.8.2, 7.3.1.1, 7.4.2>Specifically, the following comments address NABP's position regarding the
most effective method by which FDA, with the assistance of the state boards of pharmacy, may safely
allow and easily enforce the limited sale of nonprescription drug products to a particular subpopulation,
particularly emergency contraceptives.
We believe the best way to do this is via a third, transitional class of drugs, also known as a "counseling"
class of drugs. Since 1995, NABP has advocated a counseling class of drugs dispensed, without a
prescription, only by licensed health care professionals authorized to prescribe and/or dispense
prescription drugs. That year, during NABP's 91st Annual Meeting, the NABP delegation passed the
following Resolution, 91-3-95, "Establishment of a Transitional Class of Drugs;"
Whereas, there are a number of prescription-only drugs that are being converted to over-the-counter
status; and
Whereas, there are strong economic forces that are encouraging this change in status; and
Whereas, many of the drugs have serious side effects and need proper patient education for their effective
use;
Therefore Be It Resolved that such drugs be placed in a special class requiring sale only by health care
professionals authorized by law to prescribe and/or dispense prescription drugs; and
<2: 7.3.1.4>Be It Further Resolved that health care professionals authorized by law to prescribe and/or
dispense be required to counsel patients regarding the proper use of drugs in this class; and
<3: 3.8.2>Be It Further Resolved that NABP support the introduction of legislation into the US Congress
to create this new transition class of drugs.
NABP believes that a counseling class of drugs could significantly contribute to the overall safety of the
public health as more drugs are transitioned from "prescription drug" status. A counseling class of drugs
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would serve as a beneficial adjunct to FDA's plan to reclassify prescription drugs by ensuring that patients
are properly educated in medication use. In addition, it would serve as a means to implement any
subpopulation requirements to risk manage specific drugs.
<4: 7.3.1.2>In the case of an emergency contraceptive, for example, a patient's thorough understanding of
the drug's indication, directions for proper use, and adverse effect is vital to appropriate patient care and
safety. If emergency contraceptives are placed in a new counseling class of drugs, pharmacists, the
nation's most accessible health care professionals, will be able to provide such necessary information and
assistance. <5: 7.4.1, 7.4.4>Additionally, this classification would provide a mechanism for
the verification of the patient's age, if necessary, or any other subpopulation requirements. <6: 3.8.2>Overall, the implementation of a counseling class of drugs would not decrease the
accessibility of newly reclassified prescription drugs, but would ensure that appropriate patients are using
medications in a safe and effective manner.
In closing, NABP hopes that FDA will consider the counseling class of drugs as an approach to ensure
patients' proper and safe use of specific, identified prescription drug products.
If I can provide any additional information, please contact me. Thank you for the opportunity to address
this important issue.
Sincerely,
Carmen A Catizone, MS, RPh, DPh
Executive Director/Secretary
COMMENT NUMBER - 2005N-0345-C453
2005N-0345-C453 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.
2005N-0345-C453 - TEXT
COVINGTON & BURLING
1201 PENNSYLVANIA AVENUE NW
WASHINGTON, DC 20004-2401
TEL 202.662.6000
FAX 202.662.6291
WWW. COV.COM
PETER O. SAFIR
TEL 202.662.5162
FAX 202.778.5162
PSAFIR @ COV.COM
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November 1,2005
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No. 2005N-0345
Dear Madam or Sir:
We submit these comments on behalf of Aventis Pharmaceuticals Inc. and Sanofi-Synthelabo Inc.,
members of the sanofi-aventis Group, in response to the advanced notice of' proposed rulemaking
published by the Food and Drug Administration ("FDA" or "Agency') on September 1, 2005, regarding
the circumstances under which an active ingredient may simultaneously be marketed in both a
prescription and an over-the-counter ("OTC") drug product. [Footnote 1: 70 Fed. Reg. 52050 (Sept. 1,
2005).] The sanofi-aventis Group is the world's third largest pharmaceutical company, The sanofi-aventis
Group is a dynamic organization that is working to meet the healthcare needs of physicians and their
patients and is committed to researching, developing and bringing to market new and innovative
healthcare products.
In its September 1, 2005 Federal Register notice, FDA solicited comments as to whether it should
commence rulemaking to codify its interpretation of section 503(b) of the Federal Food, Drug, and
Cosmetic Act ('TDCA" or "the Act") regarding when an active ingredient can be marketed as both a
prescription and OTC drug product. [Footnote 2: Id. at 52050-51.] Specifically, FDA requested
comments on whether there is "significant confusion regarding FDA's interpretation" of section 503(b)
and if so, whether a rulemaking on the issue would resolve the confusion. [Footnote 3: Id. at 52051.]
<1: 3.10>FDA has consistently interpreted section 503(b)(l) as permitting the marketing of the same
active ingredient in products that are both prescription and OTC only if there is "some meaningful
difference" between the two, for example in conditions of use, strength, route of administration, or dosage
form. [Footnote 4: Id.] FDA has never permitted the same active ingredient to be marketed
simultaneously as both a prescription and OTC product for identical conditions of use.
<2: 3.8.6, 4.1>Nevertheless, sanofi-aventis believes that there is indeed significant confusion over the
Agency's interpretation of section 503(b) - confusion created by the Agency's October 1999 Draft
Guidance for Industry regarding "Applications Covered by Section 505(b)(2)." [Footnote 5: FDA, Draft
Guidance for Industry: Applications Covered by Section 505(b)(2) (October 1999) (hereinafter "1999
Draft Guidance" or "Draft Guidance"). ] However, sanofi-aventis believes that FDA need not initiate
rulemaking to dispel this confusion. Rather, the Agency can simply withdraw or amend its 1999 Draft
Guidance. In addition to noted confusion, the Draft Guidance raises issues of the Agency's unauthorized
"taking" of confidential data belonging to the pioneer manufacturer and the Agency's authority under
section 505(b)(2), which are beyond the scope of these comments,
<3: 4.3.1>An application under section 505(b)(2) of the FDCA is one for which the investigations of
safety and effectiveness on which the applicant relies for approval "were not conducted by or for the
applicant and for which the applicant has not obtained a right of reference or use . . . ." [Footnote 6:
FDCA § 505(b)(2), 21 U.S.C. § 355(b)(2). ]In its 1999 Draft Guidance, FDA advanced for the first time
its unsupported interpretation of section 505(b)(2) as permitting reliance on proprietary data contained in
another manufacturer's application. FDA also asserted in the Draft Guidance that a section 505(b)(2)
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application could be used to obtain a switch in product indications from prescription only to OTC.
[Footnote 7: 1999 Draft Guidance at 5.]
Insofar as it suggested that a section 505(b)(2) application is a suitable vehicle for obtaining approval of a
switch from a prescription indication to an QTC indication for another applicant holder's product, the
Agency's Draft Guidance does not account for the potential for Durham-Humphrey misbranding issues.
Under the Draft Guidance, the Agency could theoretically approve an OTC product in reliance on a
pioneer's data for an approved prescription product. That prescription product would continue to be
covered by the pioneer's NDA. The pioneer with an approved NDA for its product is entitled to -indeed
must - sell that product in conformity with the terms of its NDA, including selling it only as a prescription
product. Through its Draft Guidance, the Agency thus opened the door to the same active ingredient being
simultaneously marketed for the same conditions of use as both a prescription and an OTC drug product,
thereby creating an unworkable tension with section 503(b) of the FDCA.
<4: 4.3.1>Significantly, any attempt to remedy the inherent confusion of the Agency's Draft Guidance by
forcing the innovator company to take its product OTC upon approval of another applicant's section
505(b)(2) application would raise serious legal concerns. Among other things, section 503(b) of the
FDCA does not anticipate such broad-based OTC switches absent rulemaking. [Footnote 8: FDCA §
503(b)(3); 21 U.S.C. 8 353(b)(3).] In addition, questions of constitutional rights must be addressed.
<5: 3.8.6>FDA need not initiate rulemaking to clarify its interpretation of section 503(b) of the FLEA as
to when the same active ingredient may be simultaneously marketed in both a prescription and OTC
product. Rather, the Agency can do so simply by withdrawing or amending its 1999 Draft Guidance. By
withdrawing that guidance or striking any reference to OTC switches in that document, FDA will affirm
its practice (I) of permitting switches through the original applicant's initiative or the Agency's own
rulemaking and (2) of allowing the same active ingredient to be marketed simultaneously as a prescription
and OTC counter product only where a meaningful distinction between the two products exists. Sanofi-aventis appreciates the opportunity to comment on this advanced notice of proposed
rulemaking.
Sincerely,
Peter O. Safir
Kelly A. Falconer
Counsel for Aventis Pharmaceuticals Inc. and Sanofi-Synthelabo Inc., members of the sanofi-aventis
Group
COMMENT NUMBER - 2005N-0345-C489
2005N-0345-C489 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Women's Bar Associaion of the State of New York
2005N-0345-C489 - TEXT
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Women's Bar Association of the State of New York
November 1, 2005
Food and Drug Administration
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. 2005N-0345
RIN No. 0910-AF72
Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in
Both a Prescription Drug Product and an Over-The-Counter Drug Product
The Women's Bar Association of the State of New York ("WBASNY") is a statewide organization with
over 3,500 members across the State. Our mission is not only to promote the status of women in the legal
profession, but also to promote the fair and equal administration of justice for all women at the state,
national and international level. We submit this letter in response to the request of the Food and Drug
Administration ("FDA") for comments in its Advance Notice of Proposed Rulemaking. The FDA
requested comments after receipt of the application of Duramed Research, Inc. The Company's
application requested permission to market emergency contraception ("Plan B") over the counter to
women who are 16 years of age and older, and by prescription to women under 16 years of age.
Women's health issues are a primary focus and concern to our bar association. <1: 1.2.1>We believe that
proper and safe access to emergency contraception to avoid unwanted pregnancy is crucial. WBASNY
therefore supports making Plan B as widely available at the counter as possible to women of childbearing
age with appropriate safeguards and instructions as to use.
It has been estimated that emergency contraception could prevent over a million unwanted pregnancies
and thousands of abortions annually in the United States alone. <2: 3.8.2, 7.4.1>WBASNY has
supported legislation proposed in New York State (A. 116 Paulin/ S.3661 Spano, currently tabled) that
would allow New York State pharmacists (and registered nurses) to dispense emergency contraception to
women of childbearing age without a patient specific prescription. This legislation requires that, in
dispensing emergency contraception, a licensed pharmacist who has been trained about emergency
contraception follow written procedures and protocols. It also requires that the patient be provided with a
fact sheet containing clinical considerations, methods for use, the need for follow up care, and referral
information. We suggest the development of comparable or equivalent safeguards to the extent possible
on the federal level for over the counter use of Plan B by women. Such safeguards might address many of
the FDA's concerns about inappropriate use by teenagers. This would allow the FDA to consider
permitting access by teenagers to Plan B over the counter as a means of reducing unwanted pregnancy
and abortion rates among teenagers.
<3: 1.2.1>With regard to the specific pending application of Duramed Research, Inc., we believe that the
FDA should take whatever actions are necessary to deal with the legal and practical problems involved in
approving the application. <4: 7.4.4, 10>We caution against imposition of requirements as to
age identification or sworn statements verifying age at the counter. Since studies have shown that the
health risk involved in use of emergency contraception pills ("ECP's") by adolescents is small, we believe
that the theoretical danger of a few adolescents potentially obtaining the drug without a prescription
would be far outweighed by the advantages of adult women's ability to access it promptly in an
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emergency. [Footnote 1: See Melissa Schorr, Emergency Contraception Safe for Use in Teenage Girls,
Medscape Medical News (Nov. 18, 2003) cited by Planned Parenthood at
http://www.plannedparenthood.org/pp2/portal/files/portal/medicalinfo/ec/fact-emergency-
contraception.xml : "ECPs can also be safely used by adolescents. One study designed to evaluate the
safety of ECP use in teenagers enrolled 55 teens between the ages of 13 and 16. ECPs were found to be
safe and well tolerated by the teens. The teens took the medicine properly, and they returned to their
normal menstrual period at the same rate as adult women taking ECPs."]
<5: 1.2.1>In summary, we recommend the approval of the proposal made by Duramed Research, Inc. as a
positive first step toward allowing Plan B to be marketed with appropriate safeguards and instructions as
to use to women of childbearing age without a prescription. Should you have any questions or
concerns, please do not hesitate to contact me. Thank you for considering our comments.
Respectfully submitted,
Andrea Phoenix
President, WBASNY
COMMENT NUMBER - 2005N-0345-C5
2005N-0345-C5 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Micro ICU Project
2005N-0345-C5 - TEXT
JURIDIC EMBASSY
AMB EURICA CALIFORRNIAA
PO BOX 2328
MALIBU, CA 90265-7328
USA
(310) 804-0727
amb@juridic.org
www.ficu.org
September 8, 2005
Dockets Management Branch, HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. 2005N-0345 and RIN 0910-AF72 ("Drug Approvals: Circumstances Under Which an
Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-
The-Counter Drug Product")
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To Whom It May Concern:
The Micro ICU Project is an interdisciplinary project in micro-biomedical engineering working to create
neonatal-type incubators for pre-implantation infants using microfabrication technology, a field that has
considerably advanced in recent years. [Footnote 1: Califorrniaa, E. Method of monitoring the body
temperature of human embryos and hatchlings. U.S. Patent No. 6,694,175. Feb. 17, 2004. Prior to this
teaching practitioners failed to grasp the biophysical distinction between an incubator thermostat reading
and the patient's own body temperature!] [Footnote 2: Califorrniaa, E. Thermoregulation of human
embryos and hatchlings in a prenidial incubator using infrared microthermography. Trends in
Reproductive Biology. 2005; 1:63-67 (in press). A preprint of the article is available online at
http:/www.juridic.org/images/preprint.pdf. This is the founding paper on the subject of competent
incubator care for pre-implantation infants, and it offers ethically relevant insights.] Such incubators have
been dubbed "micro ICUs" (micro intensive care units). As the world leader in developing incubator
systems for the patient care of pre-implantation infants using microfabrication technology, the Micro ICU
Project opposes products such as the morning-after pill that may harm a pre-implantation infant.
In a statement of Aug. 26,2005 ("FDA Takes Action on Plan B"), FDA Commissioner Lester M.
Crawford raises important questions concerning the impact that liberalized distribution of the morning-
after pill "Plan B" will have on public health. <1: 2.2>The Commissioner is thanked for the opportunity to
comment on these questions.
In the language of the FDA, a "molecule" refers to a composition of matter comprising a drug treatment.
The FDA has approved two different molecules for prescription use as a morning-after pill. The molecule
known by the brand name Preven consists of a combined estrogen and progestin composition. The
molecule known by the brand name Plan B consists of a progestin-only composition.
The two molecules differ widely in their side effects and effectiveness. The short term side effects of
Preven are significantly more unpleasant than those of Plan B. Regarding differences in effectiveness,
according to Dr. James Trussell and colleagues at Princeton University, using no other method if women
made perfect use of Preven after every act of intercourse, 38% would experience a post-implantation
pregnancy in the first year of use, compared to half as many (19%) using Plan B. [Footnote 3: "How
effective is emergency contraception ?" http://ec.princeton.edulquestions/eceffect.html ]
Barr Laboratories, which owns marketing rights to both molecules in the United States, quietly withdrew
Preven from the U.S. market approximately one year ago. The exact reasoning behind this decision has
not been publicly disclosed.
The FDA is cautioned to recognize that whatever the reasons Barr Laboratories may have had for
withdrawing prescription use of Preven, the FDA's own analysis failed to anticipate these reasons in
allowing prescription use of Preven in the first place. For unlike the FDA, it appears even Barr
Laboratories eventually realized that Preven should non be on the U.S. market. In view of these
developments the importance of caution should not be underestimated because the FDA has a
responsibility to avoid making the same mistakes with Plan B such as were evidently made with Preven.
Although questions raised by Commissioner Crawford in his recent statement do recognize the need for
caution, they do so only in minor part. For those questions do not make available for comment the major
determination by the Center for Drug Evaluation and Research (CDER)-namely, that Plan B is safe as an
over-the-counter product for women who are 17 years of age and older-as if that finding were a done deal.
In an effort to promote thorough responsibility, and to invite recognition for the possibility of oversight,
the Commissioner is strongly urged to open up a lengthy period of comment so as to enable an open,
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public process to respond to the credibility of this finding.
The criticism that may be offered for such a finding is so strong and certain that one is wary that its
expression may be mistaken for an ad hominem attack. For this reason, it seems preferable to introduce
the possibility of such criticism indirectly in the form of a couple of questions.
1) Would it be unprofessional for a medical body to employ the brand name of one molecule as a generic
name for two different molecules?
2) As consumers begin to learn that one molecule is more effective than another, would it serve to defraud
consumers for a medical body to employ the brand name of the more effective molecule as a generic
name for both?
In this case, the medical body in question is the American Medical Association (AMA) House of
Delegates. Though integrity demands that both of these questions be answered in the affirmative, the
AMA demonstrated unprofessional resolve by employing the brand name "Plan B" as a generic name to
refer to both the combination and progestin-only molecules of the morning-after pill. In evidence of this
act of consumer fraud, AMA House of Delegates Resolution 443 (A-04) reads in part: "The Plan B pill is
a post-coital contraception method which transiently provides a high dose of (1) combined estrogen and
progestin or (2) progestin-only.. ." [Footnote 4: American Medical Association House of Delegates.
Resolution 443 (A-04) Re: FDA Rejection of Over-The-Counter Status for Emergency Contraception
Pills. June 12, 2004. http://www.ama-assn.org/meetings/ public/annual04/443a04.rtf] Note that Barr
Laboratories voluntarily withdrew Preven from the U.S. market shortly after the AMA resolution. From
the perspective of social analysis, it stands to reason that the members of the AMA House of Delegates
did not make credible analysis of either morning-after pill regimen, else presumably they would not have
made the mistake of equating the two different molecules using the brand name of the least ineffective of
the two. If the credibility of a medical body as distinguished as even the AMA can be drawn into
question, certainly the conclusions of the CDER should not be made exempt from public comment.
<2: 3.9.1>At any rate, the questions raised by the Commissioner in his recent statement are pertinent, and
he should be commended for bringing them to our attention. But his approach to the question of whether
the same molecule can exist in both prescription and over-the-counter forms for the same indication still
deserves a note of criticism. For in accepting the finding of the CDER that Plan B is safe as an over-the-
counter product for women who are 17 years of age and older, he appears to have contradicted his own
question by overlooking the fact that Barr Laboratories' Plan B is the same molecule as Wyeth's
prescription-only brand Ovrette, but in a different dosage. For this reason the question should be
broadened to address whether prescription and over-the-counter forms of the same molecule can exist to
straddle different dosages and/or ages.
Each of two tablets in the Plan B regimen contains the active progestin equivalent of 20 tablets in the
Ovrette regimen-a 40 tablet total. Both regimens are indicated by their labels to reduce unplanned
pregnancy. Both regimens suggest suppressing ovulation as a mode of action. The molecular equivalence
is confirmed by Dr. Trussell and colleagues at Princeton University, who recommend substituting 40
tablets of Ovrette for the two tablets of Plan B. [Footnote 5: "Twenty-one brands of oral contraceptives
that can be used for emergency contraception in the United States."
http://ec.princeton.edu/questions/dose.html ] So why would the FDA accept the finding of the CDER that
the same molecule is safe in high dosage form as an over-the-counter product for women who are 17
years of (age and older, but not in low dosage form? Since it is particularly odd to conclude that the
higher dosage of the same molecule should exist in over-the-counter form and the lower dosage in
prescription form, by circumstances alone one must conclude that the determinations of the CDER are
highly questionable. For although the FDA might consider whether different dosages can be straddled, it
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is hard to believe that the higher dosage would be the one relegated to over-the-counter status!
It is noted that important clarification is needed regarding the Commissioner's recent statement. The
statement reports that the CDER determined that Plan B is safe as an over-the-counter product, "but only
for women who are 17 [sic] years of age and older." If this is not a misprint, then the Commissioner
appears to have independently concluded that Plan B is safe for women who are specifically 16 years of
age. For according to the Commissioner's statement, the FDA is now considering whether to allow over-
the-counter use of Plan B for women as young as 16 years of age and older, rather than for women at least
17 years and older.
In considering whether Plan B should be made available in age-straddled prescription and over-the-
counter forms, the reasoning the FDA appears to have used is that 1) the research on Plan B has left out
women of the younger age group, 2) the CDER is satisfied with the research regarding the older age
group, and 3) the line between the younger and older age groups should serve to distinguish prescription
and over-the- counter forms. Of note, comments C 2044 and C 2092 of the Micro ICU Project in Vol. 300
of Docket No. 2001P-0075 demonstrate with absolute certainty the invalidity of the CDER's finding. But
even aside from this paramount issue, an unqualified assumption is made in presuming that the age
differences between research groups should automatically draw the line between prescription and over-
the-counter forms.
This is an extremely important but subtle point. The CDER did not specifically validate the safety of Plan
B for women who are, for example, 17, 18, and 19 years old. Instead, these women were included in an
overall group, and the CDER was satisfied with the results for the group as a whole. But the CDER failed
to investigate the possibility that unacceptable values for the lower aged women in the group (e.g.,
women aged 17-19) may have averaged in with better values for older women in the group. For this
reason, even if the results for the overall group had been acceptable, there would still be the possibility
that the age limit used to distinguish prescription and over-the-counter forms may still need to be set
higher (e.g., to 20 years of age) than the age of the youngest members of the group. This means even if
the FDA were to accept the CDER's finding that liberalized distribution of Plan B is safe for older
women, it would still be scientifically premature to define a specific age range of safety.
Yet if the FDA is to consider age-straddling the availability of a given molecule between prescription and
non-prescription forms, then the issue of age specificity is of critical importance. However, at present the
CDER lacks sufficient age-specific data to make such a determination regarding Plan B. Instead, for the
most part the CDER only has data to rely upon that has been averaged over a range of ages regarding
women in the group 17 years and older. No age cutoff has been scientifically established within the group
of women 17 years and older. It is spurious to rely on the lowest aged members of that group as the cutoff
point without detailed, age-specific data to back it up.
As a word of extreme caution, it may be recalled that after Sweden introduced liberalized distribution of
the morning-after pill in 1995, teen abortions rose an epidemic 32% between 1995 and 2001. As reported
by a researcher at the Karolinska Institute in Stockholm, "Teenage abortion rates have gone up, from
17/1000 in 1995 to 22.5/1000 in 2001. Genital chlamydial infections have increased from 14,000 cases in
1994 to 22,263 cases in 2001, 60% occurring among young people, and with the steepest increase among
teenagers." [Footnote 6: Edgardh, K. Adolescent sexual health in Sweden. Sex Transm Infect.
2002;78:352-356. Online at: http://sti.bmjjournals.com/cgi/content/full/78/5/352] As the American
Association for Pro-Life Obstetricians and Gynecologists (AAPLOG) points out in comment C 2042 in
Vol. 295 of Docket No. 2001P-0075, "It would seem to us that the association of an increased induced
abortion rate among teens corresponding to the availability of OTC EC [over-the-counter emergency
contraception] in Sweden is a very red flag." The basis for the predictable effect of liberalized distribution
is examined statistically in the above-stated Micro ICU Project comments. In a nutshell, the morning-after
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pill is ineffective in a liberalized atmosphere. This problem appears especially evident in teenagers, and
not just in women under 16 years of age. Though the average typical use patterns of women may improve
with age, women of any age group are not immune to the ineffectiveness based on statistical reality.
<3: 6.6.1>Even if the FDA were to attempt age-straddled distribution of the morning-after pill between
prescription and over-the-counter forms, there is no doubt that some of those eligible for non-prescription
Plan B would in effect become the prescribers to ineligibly young women. Consequently, the FDA must
question the ability of these would-be physicians to assess the risks to their would-be patients. The
enforceability of discipline in this regard is evidently very low, for even a number of states have
disregarded the process of drug evaluation by going ahead of the FDA, on their own incentives, and
allowing over-the-counter distribution of Plan B to women of any age. If even a number of states have
disregarded discipline, the same problem can certainly be expected from individuals, especially since
public opinion is volatile in the United States when it comes to reproductive rights issues.
[See original comment for figure: Pregnancy Reduction Totem Pole]
Col. I: Pregnancies per 100 women in the first year of use are paired with given methods of reducing
pregnancy. Data from the Alan Guttmacher Institute and Not-2-Late.com.
Col. II: Percentage of possible pregnancies reduced by the given method in the first year of use, assuming
85 pregnancies per 100 women in the first year using no method of reduction.
Important: These percentages calculated for the first year of use are not to he confused with reduction
percentages determined with respect to a single act of intercourse.
Note: The totem pole has been truncated. At the bottom of the full totem pole is "No method" with its
corresponding 85 pregnancies per 100 women in the first year-a 0% reduction.
In considering whether would-be physicians will be able to assess the risks to their would-be patients, it
suffices to show that even distinguished medical bodies have been unable to appreciate the risks correctly.
In other words, if even top medical bodies throughout the world have been unable to appreciate the risks,
then clearly street physicians will be unable to appreciate the risks for their ineligibly young patients. To
give an example, the Karolinska Institute is Sweden's top medical institute and is highly respected
throughout the world. As a notable distinction, members of the Institute determine who will receive the
Nobel Prize for medicine. But tragically, the Institute decided in favor of what became Sweden's policy in
1995 of instituting liberalized distribution of the combined estrogen and progestin molecule of the
morning-after pill, which in the United States is marketed under the brand name Preven.
Examining the "Pregnancy Reduction Totem Pole" on the previous page, given that the molecule branded
as Preven in this country is at the low end of the totem pole even with perfect use, it is not surprising that
liberalized distribution resulted in an epidemic of unplanned pregnancies in Sweden. This is especially
true since typical use rates will be much worse than perfect use rates. In 2001 Sweden liberalized
distribution of the progestin-only molecule marketed in this country as Plan B. Yet unlike the voluntary
actions of Barr Laboratories in this country regarding its brand Preven, Sweden did not remove the
combined estrogen and progestin molecule from the Swedish market despite its greater ineffectiveness.
This goes to show that even a medical body as distinguished as the Karolinska Institute did not appreciate
the risks that liberalized distribution of either morning-after pill would have on public health. The
miserable consequence, as is now known, was an epidemic of unplanned pregnancies and sexually
transmitted diseases that proper discipline in this country would do well to avoid.
In assessing the epidemiology of this tragedy, a strong driving force was provided by none other than the
admirably strong intentions of Swedish teens to take responsibility for their fertile capacity by listening to
authorities who offered them the morning-after pill as if a respectable new means. But like a dog being
cruelly made to chase its own tail in a miserably humiliating fashion, the more they relied upon the
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morning-after pill the higher their rates of unplanned pregnancy and abortion went up-and as their rates
went higher, their authorities became all the more determined to impose the morning-after pill on them.
Because this is truly one of the cruelest tragedies in world memory, even though it did not transpire in this
country the U.S. Congress should investigate it.
Other countries, such as England, have experienced similar results, though such experiences have been
largely damped compared to the Swedish tragedy due to relatively tight controls on the over-the-counter
distribution. Noted is that concerned citizens have been similarly bewildered by the results. For example,
as one bewildered advocate of the morning-after pill writes for a British periodical, "Astonishingly, the
greater availability of the morning-after pill over the past five years has had no real impact on teenage
conception or abortion rates . . .And in the 13 local authorities with the highest rates, 11 have seen the
numbers of teenage pregnancies increase." [Footnote 7: The Observer Magazine, Guardian Unlimited,
"Waking Up to the Morning After Pill", by Geraldine Bedell. May 15, 2005. ] So clearly if the FDA were
to allow older women to get Plan B over-the-counter, they would be unlikely to understand the tragic
risks posed in giving it to ineligibly younger women, since even distinguished medical bodies and
concerned citizens remain bewildered.
At the heart of the bewilderment appears to be an inability to appreciate three considerations: 1) the
exponential (i.e., non-linear) distinction between first year rates and per act rates, 2) the distinction
between perfect use and typical use, and 3) the problem of substituted reliance. In addition to these
considerations, it is also helpful to appreciate the meaning of acquiescence and coitivity ("co-it-TIV-it-t").
Coitivity is the rate at which a sexually active woman experiences coitus. Acquiescence is the rate at
which non-sexually active women become sexually active. To understand the importance of coitivity,
suppose Method X reduces a greater percentage of possible pregnancies per act than Method Y, but
Method X seems so sophisticated and wonderful that users increase their coitivity in relationship to its
use. On this basis, first year pregnancy rates, for users of Method X could actually be higher than rates for
Method Y. When it comes to teen sexuality, this problem presents a special concern because individual
teenagers may be especially subject to increases in coitivity inasmuch as their comparatively low coitivity
rates leave them plenty of room for increase. To understand the importance of acquiescence, suppose
Method 1 reduces first year pregnancy rates for its users to a greater extent than Method 2 does. But the
boys hear about Method 1 and think science has solved everything, so they put more pressure on the girls
to acquiesce. Even though Method 1 has lower first year pregnancy rates per user than Method 2,
popularization of Method 1 could actually result in an increase in the total number of pregnancies in the
population, based on increased acquiescence.
When it comes to the problem of substituted reliance, even the brand name "Plan B" is cleverly
suggestive in the marketing sense of substitution for traditional "Plan A" methods of pregnancy reduction.
However, advocates note that studies submitted to the FDA on this subject found no decrease in the use of
traditional methods. Actually, what those short studies found was a tremendous increase in the use of
traditional methods. Obviously, what is happening here is that researchers have failed to distinguish
between the short term effects of counseling on the use of traditional methods from the impact of Plan B
on the problem of substituted reliance. For by introducing a variable that will not be present in over-the-
counter use, namely, counseling, researchers failed to control the variable they attempted to study.
However, since literacy tests show clearly that many women fail to grasp the suggestion that Plan B
should not be relied upon in place of "Plan A" methods, there can be no question that substituted reliance
is a major problem with Plan B. The rate of sexually transmitted diseases experienced in Sweden is
clearly a "red flag" as to what can be expected from liberalized distribution. But even the literacy studies
mask the overall problem, because in many situations it is actually the male's impression that is most
controlling, not the female's. For this reason, the literacy of males should also have been tested, to learn
their thoughts on reliance possibilities.
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In a table entitled "Pregnancy Rates for Birth Control Methods", the FDA defines "typical use" to include
non-use after planned use. [Footnote 8: U.S. Food and Drug Administration. Center for Devices and
Radiological Health. Uniform Contraceptive Labeling. CDRH Facts on Demand Document Shelf No.
1251. Issued July 23, 1998. Table prepared by FDA: 5/13/97, revised 9/17/98.
http://www.fda.gov/cdrh/ode/contrlab.pdf ] Noted is that perhaps "typical reliance" would be better, since
in some cases there is no actual use. Perfect use includes times of correct use and excludes times of non-
use and times of incorrect use, whereas typical use includes all of these times. Non-use means couples
and individuals who consider themselves users of a method may lapse in its use. Typical use rates have
not been estimated for either Plan B or Preven.
Suppose every time a woman seeks Plan B her doctor administers it to her according to the prescription
label and makes a house call to ensure she takes the two doses. It would be a mistake to assume this
woman will necessarily experience the rate of pregnancy associated with perfect use. For example,
suppose the woman lets her boyfriend skip condom use thinking she will go to the doctor the next day.
But the next day she forgets about her plans. In such a case she exhibits non-use after planned use, even
though on other occasions she follows through and goes to her doctor. This means her rate of pregnancy
will be higher than the perfect use rate. We cannot assume prescription use necessarily implies a perfect
use scenario. Instead, even prescription use can include non-use after planned use. Thus, the FDA is
faulted for allowing even prescription use without an estimate of typical use rates; moreover, it is
unconscionable to consider over-the-counter use without a typical use estimate.
Comments C 2044 and C 2092 of the Micro ICU Project in Vol. 300 of Docket No. 2001P-0075 have
explained the exponential difference between first year pregnancy rates, known elsewhere as "first year
contraceptive failure rates", versus "per act" rates of pregnancy reduction, meaning per act of intercourse.
For example, the difference between an 89% per act rate and a 75% per act rate is actually a two-fold
increase in terms of first year pregnancy rates; the difference between per act rates of 99% and 97% is a
three-fold increase in first year rates; and the difference between per act rates of 99% and 75% is a
nineteen-fold increase in first year rates. The following graph depicts this exponential relationship using
the data of Table 1 in comment C 2092. As explained in comment C 2044, the form of this graph differs
from Chart 1 in comment C 2092 in that the first year rate is expressed as a percentage of pregnancies
reduced, on the basis of an expected rate of 85 pregnancies per 100 women in the first year of using no
method.
[See original comment for figure: Pregnancy Reduction Curve]
It may be noted that the typical use rate for the withdrawal method of 27 pregnancies per 100 women in
the first year of use is taken from the Alan Guttmacher Institute, which relied on a report from Fu et a1.
[Footnote 9: Fu, H., Darroch, J.E., Haas, T., and Ranjit, N. Contraceptive failure rates: new estimates
from the 1995 National Survey of Family Growth. Fam Plann Perspect. 1999;31:56-63.] In contrast, Dr.
James Trussell, whose work the FDA relied upon to compile its table entitled "Pregnancy Rates for Birth
Control Methods", states a typical use rate of 19 pregnancies per 100 women. [Footnote 10: Trussell, J.
Contraceptive efficacy. In Hatcher, R.A., Trussell, J., Stewart, F., Cates, W., Stewart, G.K., Kowel, D.,
and Guest, F. Contraceptive Technology: 17th Rev. Ed. New York, NY: Ardent Media, 1998.] Trussell's
own rate for typical use of the withdrawal method is identical to the perfect use rate he and his colleagues
have determined for Plan B and which the FDA relied upon. Typical use rates for Plan B will be worse
than perfect use rates.
In contemplating the extent to which typical use rates will worsen compared to perfect use rates, the rate
of non-use after planned use L ("L" is for lapse) and incorrect use M ("M" is for misapplication or
misuse) must be considered. With relatively straightforward methods such as the condom or withdrawal
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methods, it may be valid to presume that M is relatively small. This may also be the case with methods
such as the diaphragm, given that patients are instructed to proficiency on correct use. In contrast, the use
of a method such as Plan B is not so straightforward and therefore may involve higher rates of M,
particularly in the context of over-the-counter use. This appears to have been confirmed by literacy
studies and other experience. Another problem is that uneducated women with over-the-counter access
may fail to propagate accurate information about use when in effect "prescribing" Plan B to ineligibly
younger women. Thus, in estimating the typical use rate, it is reasonable to expect that the value for M
will be unusually large for the morning-after pill compared to a method like the condom.
Comment C 2092 of the Micro ICU Project in Vol. 300 of Docket No. 2001P- 0075 has considered the
increasing trend of the lapse rate L associated with a comparison of pre-coital, inter-coital, and post-coital
methods of pregnancy reduction. Inter-coital means the practice of the method takes place during
intercourse. Noted is that the lapse rate for the withdrawal method-an inter-coital method-is roughly twice
as high as that for the condom-a pre-coital method. Even without having the results from Swedish
experience before us, it stands to reason that the lapse rate for a post-coital method will be even higher
still, simply because behaviors after intercourse can differ widely compared to behaviors planned for
before intercourse, based on a large variety of circumstances, some of which are not under individual
control. Thus, in estimating the typical use rate, values for both M and L will likely be much larger for a
post-coital method such as Plan B compared to values for other methods. This means Plan B's typical use
rate will fall back dramatically compared to the perfect use rate, which is already on the low end of the
scale.
In addition to failure to estimate the typical use rate, it appears the FDA has not fully applied the meaning
of typical use. For example, it has been mistakenly reported that the high price of Plan B will inhibit
reliance. On the contrary, what the high price means is that women planning to rely on Plan B will be less
likely to experience actual use. One thing is reliance; another thing is the experience of use. The high
price will serve to increase the typical use occurrence of non-use after planned use. Another factor
concerns negative reinforcement. Since Plan B and Preven offer unpleasant side effects as well as
problems of conscience, past users may be inhibited from following through on future plans of use. This
highly important area has not been investigated.
In addressing the issue of safety, it is imperative to apply a coherent standard. For example, it would not
be "safe" for teens to be unwittingly exposed to increases in unplanned pregnancy and sexually
transmitted diseases after being misled to believe that Plan B is effective. It may be noted that FDA
research on sexually transmitted diseases has been obscured by the short term effect of counseling, which
not only showed an increase in the use of traditional methods, but preference for the condom. For this
reason, unlike the real-life results experienced in Sweden, it is not surprising that these studies appear to
indicate no increase in sexually transmitted diseases.
In addressing the issue of safety, it is imperative to apply a coherent standard. Some contend that Plan B
is as safe as aspirin. But if anything is "as safe as aspirin" it must be aspirin itself. So in consideration of
the drug safety issue, suppose a woman visits her doctor and says, "Sometimes I have trouble with my
partner and he gives me a headache. So I decided to take 20 aspirin, followed by another 20 aspirin 12
hours later- not because I had a headache, but because I had contact with him and I was afraid I might get
a headache later on." Obviously it would not be reasonable for the FDA to conclude that this practice is
safe for women simply because millions of women have used aspirin safely. Yet the FDA has adopted the
similar assumption that Plan B is safe simply because it believes many users of Ovrette have been largely
free from safety problems. However, to review the above comparison, each tablet of Plan B contains the
active progestin equivalent of 20 tablets of Ovrette-a 40 tablet total.
To review the analogy further, women are instructed to take this phenomenal dosage of progestin, not
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because they know they have an impending pregnancy to avoid, but simply out of fear that a possible
pregnancy might be on their horizon after contact with their partners. Comment C 2053 of the Micro ICU
Project in Vol. 300 of Docket No. 2001P-0075 examines the inefficiency of this practice, and Comment
2092 of the same docket elaborates on it further. In a nutshell, with perfect use limited to the two mid-
cycle weeks, 93% of the time a woman will take Plan B for nothing. Looked at another way, with perfect
use limited to the two mid-cycle weeks, for every 14 times women take Plan B, one pregnancy will have
been reduced. This does not mean one pregnancy in net; it simply means to reduce a single pregnancy at
all. By comparison this total represents the progestin equivalent of taking 1-1/2 years worth of Ovrette.
Outside the two mid-cycle weeks, when fertility is greatly decreased, the figure of inefficiency will be
even higher still, and the sky is the limit regarding women who are infertile to begin with. With typical
use, the inefficiency will climb even further due to misapplication or misuse. Despite this phenomenal use
of progestin, net pregnancy rates will actually increase due to the typical use ineffectiveness of the
regimen under liberalized distribution.
Notably, AMA Resolution 443 (A-04) begins by saying that widespread use of the morning-after pill
could reduce 1.7 million unplanned pregnancies in the United States annually. According to the Alan
Guttmacher Institute, there are about three million unintended pregnancies in the U.S. annually. So
reducing 1.7 million unplanned pregnancies would mean a 57% annual reduction. But even with perfect
use of Preven, assuming no increase in coitivity or acquiescence, only 55% of pregnancies would be
reduced annually-a very low value compared to perfect or even typical use of other methods. In other
words, even if the definition of "widespread use" meant that all women who are not planning to get
pregnant will make perfect use of Preven after every act of intercourse in addition to their usual methods,
with absolutely no increase in coitivity or acquiescence, the AMA's expectations still would not be
fulfilled!
Instead, as has been evidenced in Sweden, something along the lines of the complete opposite happens.
Women do not use the morning-after pill in addition to their usual methods, they substitute it for their
usual methods. Instead of making perfect use, they exhibit non-use after planned use in a typical use
scenario. Also, the rates of coitivity and acquiescence increase. And so with liberalized distribution the
predictable result is an epidemic of unplanned pregnancies, with no net reduction in unplanned
pregnancies at all. So clearly the members of the AMA House of Delegates did not make a credible
analysis of the morning-after pill in offering us their consensus.
The bias physicians have for presuming the effectiveness of pills predates the double-blind study. Indeed,
it is with great irony that the logic of the double-blind study still escapes the medical community even
today. For example, a research director at a psychiatric medical association, responding to researcher
claims that antidepressants do not work, was recently quoted in the news as saying, "The interesting issue
is that it is now medical malpractice not to treat major depression with medication. If in fact there were
nonsignificant differences (between antidepressants and placebo), that would not be the standard of care."
[Footnote 11: Reuters Health, "Antidepressant Efficacy May Be Overblown -Experts", by Karla Gale.
Jul. 15, 2005 (correction Jul. 19, 2005).] But contrary to this assumption, if a trial medication can be
distinguished from a placebo based on its spectrum of side effects, doctors may single out the trial
medication and apply the biased presumption that the pill works.
Identifying positive results for a trial medication as often as a placebo signals problems in a study of its
effects on a condition unlikely to improve spontaneously. But logically the reverse is not true: Choosing a
trial medication over the placebo does not imply it works! For example, doctors may have been alerted to
the trial medication's identity based on the side effects it produces; in turn they may have associated
positive results with it, due purely to their biased belief that the "real" pill works.
A breed of psychotropic drugs has capitalized on this design flaw in drug tests, which allows various
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useless drugs to pass their clinical trials. These psychotropics have withdrawal patterns, the symptoms of
which are relieved by re-administering the drug. Mental illnesses, anxiety disorders, and learning
difficulties have been targets because the symptoms of withdrawal mimic the disorder under treatment.
Unaware that this is the case, doctors, patients, and their families may become loyal to the drug once they
witness its apparent power to relieve symptoms. In other words, it appears to them that the drug is
relieving symptoms of the disorder under treatment, when really it is relieving symptoms caused by an
attempt to withdraw from the drug. This side note underscores the need for the medical community to
review its undisciplined infatuation with pills.
No doubt, many a young man would be infatuated with the notion that science had somehow created the
chemical equivalent of the "undo" button on your computer in pill form-and that it sends the stork
packing back to the cabbage patch, with no pregnancy or abortion to worry about. Two weeks away from
his high school graduation, a young man with right-wing roots responded with a gleam in his eye to let it
be known where even he departs from traditional conservatives, saying, "But the morning-after pill--I
think that's a really good thing." It did not take much to remember what it was like to be 18 years old, nor
did it take much to realize that the morning-after pill is poised to create an epidemic of unplanned
pregnancies. More so than any data on the morning- after pill, the gleam in his eye provided the best tip
on the epidemic to come.
The infatuation with pills is so strong in our medical community that it may be virtually impossible,
psychologically, to break the biased belief that the pills work very well and that a whole consensus of
experts has already validated them. [Footnote 12: If one reviews Sell v. United States, 539 US 166
(2003) it is evident that our legal system has had such an infatuation with pills and those who prescribe
them that one may even be forced to take them. ] So to get the point across concerning the dangerous
ineffectiveness of Plan B in a liberalized scenario, it may be necessary to use a different example of a
post-coital method-namely, one that does not involve any kind of pill. For example, Casanova's lovers are
reported to have used a lemon juice douche post-coitally to reduce pregnancy.
In general, if people have intercourse independently of their knowledge of a given method or its
availability (i.e., knowledge of the method does not increase coitivity or acquiescence), then the use of the
method will-under controlled circumstances-serve to reduce some amount of pregnancy compared to
using nothing at all. The slight of hand played on the mind in considering a post-coital method is that the
notion that intercourse has already occurred creates a sense of comparison to using nothing at all. For
example, if a woman experiences condom breakage, and then she uses a lemon juice douche in response
to the problem, some might conclude, "It's better than nothing at all." But what happens when the method,
like the morning-after pill, is ineffective compared to other methods on the totem pole? And what
happens if the method is advertised like something really great-something that even Casanova would use?
What happens is that when the boy forgets his condom, and the girl does not want to give him a hard
time, she will think it is okay just to use "that lemon juice thing" after sex. In pill form, this is what
happened in Sweden. Teens started relying on "that morning-after pill thing". They thought it was
something great that doctors and scientists had recently invented to keep them from getting pregnant.
Instead, they ended up with an epidemic increase in unplanned teen pregnancies and sexually transmitted
diseases.
If one is not to be terribly naive it must be admitted that there are those among us who reap their fortunes
of social, political, and financial currency based on women's dependency on abortion. Looked at from a
business perspective, the most significant statistic relating to the abortion industry is the annual number of
abortions. According to the Centers for Disease Control and Prevention (CDC), "Overall, the annual
number of legal induced abortions in the United States increased gradually from 1973 until it peaked in
1990, and it generally declined thereafter." [Footnote 13: Strauss, L.T., Herndon, J., Chang, J., Parker,
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W.Y., Levy, D.A., Bowens, S.B., Zane, S.B., and Berg, C.J.; CDC. Abortion surveillance-United States,
2001. MMWR Surveill Summ. 2004;53: l-32.] As one can imagine it would for any business, a
downward trend in abortion may have sounded the alarm for those whose very fortunes rely on the
dependency women have on abortions. This consideration may provide insight into what otherwise might
seem like a puzzling contradiction.
Namely, reproductive choice advocates like Planned Parenthood waited until 1994-amid declining
abortion rates-to push for urgent FDA backing of the morning- after pill, as if America's best kept secret.
But the "secret" was known since the 1960s. So if reducing unplanned pregnancies was truly their aim,
and they truly believed the morning-after pill would have this effect, why didn't they push for it back
when abortion rates were increasing? But on the other hand, if they knew the morning-after pill would
actually increase abortion rates like it did in Sweden, this might solve the puzzle, For if they knew
deploying the morning-after pill would actually reverse falling abortion rates, this might explain why the
abortion industry's support for it is now so adamant.
A recent news story attributed to Jim Sedlak, director of STOPP International, a group that monitors
Planned Parenthood, alleges that documents made public in a court trial have revealed a "sweetheart deal"
between Planned Parenthood Federation of America, Inc. (PPFA) and Barr Laboratories (Barr). The story
reads: [Footnote 14: Lifenews.com, "Planned Parenthood Turns Sweetheart Deal on Morning After Pill
Sales", by Jim Sedlak. Aug. 24, 2005. http://www.lifenews.com/nat1563.html ]
One of the documents is a February 9, 2004 e-mail from the PPFA vice president of medical affairs,
Vanessa Cullins, M.D., to all Planned Parenthood affiliate CEOs. The executives were told that Planned
Parenthood was "in the midst of confidential discussions" with Barr and that Planned Parenthood's
"immediate interest is to develop
and protect our market base."
According to Sedlak's allegations, Barr Laboratories agreed to sell Plan B to Planned Parenthood at $0.25
less than the $4.50 price given to the public sector. The average sale price, Sedlak noted, was $25 at
Planned Parenthood clinics-hardly a "sweetheart deal" for women seeking help to reduce unplanned
pregnancy.
No doubt, maintaining women's dependency on abortion would indeed protect the "market base" of the
abortion industry. But it would be unwise to allow the abortion industry to "develop" this market base by
promoting a method of pregnancy reduction that with liberalized distribution will have the unwitting
effect of actually increasing abortion rates, and to allow the abortion industry to profit additionally by
selling women the very pills that in effect make the dog chase its own tail, as in Sweden.
Presumably Barr Laboratories realized that the liabilities of the two morning-after pill regimens would be
more easily exposed, by comparison of the differences in their ineffectiveness for liberalized distribution,
if Preven, the more ineffective of the two, were allowed to stay on the U.S. market. This would explain
the product's removal from the U.S. market, even despite the support Preven received from authorities
such as the AMA House of Delegates. The remaining question is whether Barr Laboratories felt it could
somehow gain protection from the liabilities associated with Plan B by maintaining a "sweetheart"
relationship with the powerful abortion industry lobby.
The FDA should be cautioned to reflect that unlike real medical procedures, it is not mandatory to report
abortions to the CDC. Voluntary reporting to the CDC is largely under the control of the abortion
industry. Although the CDC has enumerated the importance to public health of accurate reporting of
abortions, the reliability and completeness of voluntary reporting has been limited. Additionally, CDC
reports on abortion surveillance become available only several years after the year for which the data has
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been collected. Consequently, this means that the FDA would have to wait years before assessing the
impact of Plan B on abortion rates. Because abortion rates are notoriously subject to underreporting in
this country, it is plausible to believe that the rates may even be tampered with to mask the true impact of
Plan B. Alarmingly, California, the nation's most populous state, and one of the states that decided to
abandon the FDA's drug evaluation process by instituting over-the-counter access on its own to Plan B for
girls and women of all ages, does not even report abortions at all. Similarly, teen pregnancies are only
casually monitored in this country. Thus, the FDA's real ability to assess Plan B's effect on pregnancy and
abortion will be badly limited.
Comments C 2044 and C 2092 of the Micro ICU Project in Vol. 300 of Docket No. 2001P-0075
underscore the statistical reasons why post-coital methods, being subject to a large lapse rate L, are
contraindicated for popularization in a typical use scenario, no matter how effective they may be with
perfect use. So when someone says, "The condom broke," we must have the discipline not to fall prey to
the presumption that a post-coital approach to the problem should be liberally popularized. Instead,
looking ahead, a pre- coital discipline should always be emphasized. This might include engineering
better standards for condoms. It also means teaching people that the technology best suited for those who
wish to completely separate sex and responsibility is abstinence.
Because it will be administered in a controlled setting, a method of preventing fertilization post-coitally
would be desirable for rape victims, provided the method does not have a concepticidal component.
Concepticide is the taking of the life of a conceptus. Methods with a concepticidal component would be
especially problematic for women who have been actively seeking pregnancy, because the method would
be more likely to harm a child conceived by her partner than by the offender. In cases where conception
by rape does occur, and the victim is unable to continue her pregnancy, the technology is now feasible to
1) detect and locate the conceptus prior to implantation, 2) separate him or her from the victim, 3) transfer
the conceptus to an incubator (micro ICU), and 4) transfer her or him to an adoptive or surrogate mother
within the timeframe associated with pre-implantation events. Importantly, this separation procedure is
medically distinct from an abortion in which no effort is made to preserve the life of the child.
If preventing fertilization post-coitally would be desirable for rape victims, why not for women with other
reasons? The tough answer is that life is not based on what is desirable. You have to take real life into
account. In the case of rape, use of a post-coital method would satisfy the condition that the act of
intercourse took place independently of knowledge of the method. Without this condition being satisfied,
women will substitute the post-coital method for other methods, and sometimes they will not even follow
through on their plans of reliance. The former problem is of special importance when the post-coital
method is inferior to the other methods. The latter problem will be true of any post-coital mechanism that
is not permanently in place or otherwise independent of the woman's actions. It takes discipline to account
for these factors. Like sex, life is not always based on what is desirable; instead you have to take practical
considerations into account. Otherwise, you will end up with a tragedy like Sweden did.
When people dream unrealistic figures it is good to take out a calculator and do a quick reality check. For
example, did Barr Laboratories ever tell the FDA it has plans to sell in excess of 23.8 million units of
Plan B per year? At minimum, 14 units of Plan B will be taken on average for every one pregnancy
reduced. So to fulfill the AMA's morning-after pill fantasy of reducing 1.7 million pregnancies annually,
it would take no less than 23.8 million units. At $25 per unit, this would put revenues for Plan B at $595
million per year, with Planned Parenthood taking a piece of the cake. Recall also that this lavish
expenditure to reduce pregnancies will not reduce pregnancies in net, since in net liberalized access to the
morning-after pill serves to increase pregnancies. Instead, it simply means that to reduce 1.7 million
pregnancies, on an individual basis, it would take 23.8 million units of Plan B at absolute minimum.
The figure of 14 units of Plan B per pregnancy reduced is determined by first multiplying the odds of
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pregnancy (0.08) by the fraction of them reduced (0.89) per use of Plan B, which gives the odds of actual
pregnancy reduction per use, and then taking the reciprocal. This minimum figure is based on the
unrealistic assumption that all women will make perfect use of Plan B during the two mid-cycle weeks
and will not combine it with other methods that have some effect. Otherwise, the likelihood that an
instance of use will actually have the effect of reducing a pregnancy will be less, because the odds of
pregnancy are less at other times of the cycle as well as when women are simultaneously using other
methods that have some effectiveness.
In a subtle way, Plan B's prescription label actually serves to mask the overall rate at which women will
be taking the drug for nothing. To be clear, "for nothing" means times of taking Plan B when either they
would not have gotten pregnant anyway, or when Plan B does not reduce a pregnancy anyway because
they ended up with one even despite taking the drug. The label is faulted for masking the problem of the
overall rate at which women will be using the drug for nothing because it quotes a value for natural
pregnancy expectation of 8% that is only valid during the two mid-cycle weeks, when pregnancy
expectation is highest. But the label does not limit the indications of use to specific weeks of the cycle.
Yet women who take Plan B during the infertile portions of their cycles, like women who are infertile,
will always be taking it for nothing.
According to MedlinePlus drug information, a service of the U.S. National Library of Medicine and the
National Institutes of Health, "Combined estrogen and progestin oral contraceptives may increase the risk
of getting breast cancer, endometrial cancer, and liver tumors. It is not known whether progestin-only oral
contraceptives also increase the risks of these conditions." [Footnote l5: "Progestin-only oral
contraceptives" http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a602008.html] Recalling that
one unit of Plan B contains the active progestin equivalent of a 40-day supply of Ovrette-an enormously
large dosage-one seriously questions the epidemiological impact that taking Plan B may have on women's
risk of getting cancer. Especially alarming is that women will be taking Plan B for nothing at such a high
rate, and that Plan B's net effect of increasing unplanned pregnancies with liberal access will be
counterproductive to begin with.
Unfortunately, the medical community behaves in an odd way when it comes to an evaluation of the
health effects of matters that implicate concepticide. For example, the unqualified claim persists that
abortions are safer for women than birth. The claim is unqualified because it does nothing to rule out the
possibility that abortions, whatever their risks, present a compounding risk factor. Women who have
abortions do so predominately before they complete their lifetime number of births. For this reason,
abortions may largely tend to forestall the completion of a woman's desired birth pattern, thereby
subjecting her to added risks by enabling her to balk at the child-bearing process via abortion. In other
words, abortion risks may largely be additive.
Another example concerns evaluation of the impact abortion has on breast cancer. For example, contrary
to general assumption, the famous study of Melbye et al. did not eliminate recall bias, because the study
failed to "recall" abortions for some of the older women. [Footnote 16: Melbye, M., Wohlfahrt, J., Olsen,
J.H., Frisch, M., Westergaard, T., Helweg-Larsen, K., and Andersen, P.K. Induced abortion and the risk
of breast cancer. N Engl J Med. 1997;336:81-85.] In other words, as far as figures go, the numbers do not
care who is failing to do the recalling, whether it is the researchers or the women under study. This makes
it seem all the more amazing that the study managed to pull a one-point-zero-zero figure for relative risk
out of its hat. Analysis of the range of uncertainties associated with crude and adjusted figures also
suggests that the latter's range is too narrow to have undergone proper error propagation in adjusting the
former's value of 1.44. [Footnote 17: Brind et al. state the value of the crude figure but not the
corresponding range of uncertainty. In response Melbye et al. manage to give a partially adjusted figure
with an upper range that is narrower (in parts per million) than that of the corresponding crude figure on
which it is based! Brind, J., Chinchilli, V. M., Senghas, R. E., Dolan, M. F., Melbye, M., Wohlfahrt, J.,
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and Andersen, P. K. Induced abortion and the risk of breast cancer. N Engl J Med. 1997;336:1834-1835.]
Yet as with support for Plan B, we are told everything has been validated by an expert consensus.
Evidently some element of reform is needed in our medical community, which seems to be living in a
time warp. Even new medical students are not receiving the most up-to-date education. For example,
despite being introduced by the Medical Students Section, AMA House of Delegates Resolution 443 (A-
04) makes reference to "ovum implantation", underscoring the problem that even our new students of
medicine are not being familiarized with the fact that ovum implantation is known to be a complete myth.
Instead, human babies must literally hatch from their eggs before implantation.
Of medical concern, Plan B may have a concepticidal ("conceptus-killing") component, particularly
during the pre-implantation stages of life. These stages include what are properly known as the embryo
and hatchling stages. As shown in the photo below, the transition between embryo and hatchling stages
occurs at hatching time, taking place about 5-6 days after fertilization. The baby below is hatching in the
two o'clock direction through a hole in the eggshell. The baby's body is surrounded by a fluid-filled
precursor of the birth sac in primordial form, which serves as a protective spacesuit. Despite the ignorance
of our medical profession, these babies hatching are every bit as important as the ones you see crawling
across the floor.
[See original comment for figure: A Human Baby Hatching]
Because of the problem of concepticide, legality presents a consideration regarding over-the-counter
status for Plan B. Notably the definitions of "pregnancy" and "abortion" used in Dorland's Illustrated
Medical Dictionary are broad enough to include the conceptus during the pre-implantation stages of
gestational life. Although some authorities may beg to differ with these definitions, it appears nonetheless
that the U.S. Supreme Court has traditionally relied upon Dorland's. In Roe v. Wade, 410 U.S. 113
(1973), the Supreme Court made expressly clear that a woman may neither decide nor effectuate an
abortion on her own; instead, as stressed in Roe, "the abortion decision and its effectuation must be left to
the medical judgment of the pregnant woman's attending physician." 410 U.S., at 164. Yet based on its
concepticidal potential, over-the-counter distribution of Plan B would violate that ruling by enabling a
woman to decide and effectuate an abortion herself. Similarly, section 503(b)(1)(A) of the Federal Food,
Drug, and Cosmetic act does not limit the concerns of a drug's "toxicity or other potentiality for harmful
effect" to the woman herself, thus providing further indication that unsupervised use of Plan B is strictly
illegal based on the adverse implications the drug may have for
her conceptus.
As a technology, if Plan B did not have a concepticidal component, but instead only prevented
fertilization, an application for over-the-counter status would still face the broad standards of inquiry
posed by the Commissioner's notable questions. But Plan B presents additional legal complexities based
on its concepticidal potential. For it would be unprecedented for the FDA to enable a woman to decide
and effectuate her own abortion, in any form, apart from the medical judgment of an attending physician.
For example, birth control pills and intrauterine devices, which some believe may have a concepticidal
component, require an attending physician because they are only available as prescription products.
Notably, all concepticidal products would be banned outright if the Government were to protect the
person by outlawing concepticide altogether.
From the photo on the previous page, it is clear that hatching is a very intelligent human behavior, and
one that defies the traditional neurological paradigm. Instead, we have to think of brain power based on
molecular computing inside the cells, and that the neurons formed later represent specific interconnects.
Understandably, many users of Plan B would be shocked to learn that they may have caused the demise
of an intelligent human baby engaged in behaviors such as hatching prior to implantation.
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Early pregnancy tests are evolving to detect conception prior to implantation. However, apart from an
early pregnancy test, there will be uncertainty as to whether or not a given use of Plan B prevented
fertilization, destroyed a conceptus, or was taken for nothing due to infertility at the time of use. From an
emotional and psychological perspective, uncertainty about the possible destruction of a conceptus may
present cause for morbidity. Consequently, states require abortion providers to perform a pregnancy test
in advance of an abortion. But with Plan B this compliance will generally be lacking, particularly with
over-the-counter use. In this regard, the FDA has an obligation to research and consider the facts
thoroughly in an effort to protect a woman's conscience from serious harm. 'Though some would keep
women in the dark under the pretense of protecting them, the potential for awareness about the lives of
pre-implantation infants is rapidly evolving thanks to medical programs like the Micro ICU Project.
Obviously the application to liberalize access to Plan B should be denied. But most of all, the FDA should
evaluate the concepticidal potential of its regulated products and reject their approval accordingly.
Sincerely,
Mr. Eurica Califorrniaa, Amb.
Juridic Embassy, Micro ICU Project
ATTACHMENT:
Dockets Management Branch HFA-305
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Dear Dockets Management Branch Food and Drug Administration
Re: Docket No. 2005N-0345
I am infuriated that the Food and Drug Administration (FDA) has refused to make Plan B emergency
contraception available over the counter. The latest delay is an unnecessary road block in what should
have been a clear path to FDA approval of the Plan B application. An unprecedented medical and
scientific consensus - both inside and outside the FDA - shows that women of all ages can use Plan B
emergency contraception (EC) safely and effectively without a prescription.
The FDA continues to use the unfounded and specious argument that Plan B would promote promiscuity
among teenage girls. The FDA's job is to judge the safety and efficacy of drugs rather than impugn the
morality of people who use them. The FDA has a legal obligation to act on the scientific evidence and
promote public health. There is absolutely no justification for denying women over-the-counter access to
this safe and effective method of contraception
Contraceptive use has led to dramatic declines in maternal and infant mortality rates and has been the
driving force in reducing national rates of STDs, unintended pregnancy and abortion. However, America
isn't where it should be in guaranteeing access to contraception. The U.S. continues to have the highest
rate of unintended pregnancy In the industrialized world - almost half of all pregnancies are unintended
and half of those end in abortion.
Emergency contraception (EC) is an effective way to prevent unintended pregnancy after unprotected sex
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or a contraceptive failure. Widespread use could prevent as many as half of the three million unintended
pregnancies each year, including as many as 700,000 that now end in abortion. However, speed is most
important in maximizing the electiveness of EC which is why over-the-counter access is so critical. If
taken within 72 hours of intercourse, EC can reduce the risk of pregnancy by as much as 89 percent and
efficacy is greatest if the drug is taken within 24 hours. The American College of Obstetricians and
Gynecologists (ACOG) noted that the need to obtain a prescription from a doctor is one of the biggest
barriers to EC use.
By endlessly delaying a decision on Plan B, the FDA is failing to be part of public health effort to reduce
our nation's staggering rates of unintended pregnancy I strongly urge the FDA to approve the application
to make Plan B available over-the counter without further delay.
COMMENT NUMBER - 2005N-0345-C54
2005N-0345-C54 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: LaChance, Robin
2005N-0345-C54 - TEXT
September 30, 2005
Food and Drug Administration, HHS
Division of Dockets Management
Docket No. 2005N-0345
RIN No. 0910-AF72
5630 Fishers Lane, Room 1061
Rockville, MD 20852
To whom it may concern:
We object to the over-the-counter sale of Plan B for the following reasons:
<1: 1.2.3>Plan B is a powerful hormonal drug that can prevent a developing embryo from attaching to the
uterine wall, causing an early abortion.
Plan B has not been tested for its effects on under-age girls. If the FDA approves the drug for over-the-
counter sale, 16- and 17-year-old teenage girls will be able to purchase it without a prescription and
without the knowledge or consent of their parents.
<2: 7.5.3>Girls under 18 who are sexually active are often victimized by predatory adult (over 18) males.
Allowing over-the-counter sale of "Plan B" would allow men to procure the drug with the intention of
using it to ensure that their victims, willing or not, never show the consequences of their behavior.
Remember, sexual activity on the part of an adult with a minor is statutory rape. In that case, "Plan B"
conceals the crime.
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<3: 1.2.3>"Plan B" gives a false sense of security while leaving a young girl or woman open to the
transmission of sexually transmitted diseases including HIV. Between the years 1995 when Plan B
became available over-the-counter in Great Britain, and 2000, diagnosis of genital Chlamydia went up
77%, gonorrhea by 57%, and syphilis by 56%, according to the British Health Service. (Paul Caprio,
Family- PAC Federal - 9/9/05)
"Plan B," according to the website of its manufacturer Barr Labs, "may inhibit implantation by altering
the endometrium. " In other words, "Plan B" can work to abort a developing human baby by preventing
him from attaching to the wall of the uterus. Plan B kills.
I urge the FDA to NOT approve the sale of the Morning after pill (Plan B) (without a prescription) to girls
16-years-old and above.
Sincerely,
Robin L. LaChance
2825 Lexington Rd. SBTS 80-388
Louisville, KY 40280
COMMENT NUMBER - 2005N-0345-C61
2005N-0345-C61 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Family Planning Advocates of New York State
2005N-0345-C61 - TEXT
Family Planning Advocates of NYS
17 Elk Street
Albany, New York 12207-l 002
Phone: (518) 436-8408
Fax: (518) 436-0004
Website: www.fpaofnys.org
October 7, 2005
Food and Drug Administration, HHS
Division of Dockers Management
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
RE: RIN 0910-AF72
Docket No. 2005N-0345
Dear Acting Commissioner von Eschenbach;
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Family Planning Advocates (FPA) is a nonprofit organization that represents family planning providers in
New York State, including the state's thirteen Planned Parenthood affiliates, As an organization, we are
committed to the goal of reducing the rate of unintended pregnancy in New York State. Increasing access
to emergency contraception (EC) is important to achieving that goal, and we therefore support making
Plan B an over the counter medication for women of all ages.
<1: 3.2, 4.2, 5.2>In response to the questions posed in RIN 0910-AF72, FPA believes the first three
questions (lA, 1B and lC) should be answered in the negative, making it unnecessary to address the
remaining questions. We do not believe there is any confusion over the interpretation of section 503 of the
Federal Food, Drug, and Cosmetic Act. <2: 2.3>We feel it is clear that the &lays in
approving the application to classify Plan B as an over the counter medication, and request for
information these comments address, are the result of inappropriate political interference as opposed to
"significant confusion" over section 503's interpretation, The questions lover how to label, market and
enforce an age-restricted medication are the end result of a process that has allowed politics and ideology
to interfere with decisions that should be based on medical fact and reason.
<3: 3.2>The mission of the FDA is to protect "the public health by assuring the safety, efficacy, and
security of human and veterinary drugs.. . ," not to pander to politically motivated opposition where
objections have no grounding in medical or scientific research. Because the questions posed in the
Request for Information are not the result of medically supportable facts that necessitate placing age
restrictions on the medication's USC, it is simply inappropriate for the questions to be considered in
conjunction with the FDA's consideration of the Plan B application. We do not support initiating a rule-
making process in relation to Plan B.
<4: 3.5.2>EC approval process diverges from FDA mission
We are concerned that the FDA has diverged from its role of determining whether a medication that is the
subject of an application seeking exemption from prescription-dispensing requirements, is "safe and
effective for use in self-medication . . . ," [Footnote 1: 21 C.F.R. §310.200(b). ] FPA has watched with
dismay as politics has interfered with the application to make Plan B available as an over the counter
medication, Despite the recommendation of two FDA advisory committees that the application be
approved, the application was denied. Similarly, the pending application has now been deferred for
reasons that have no grounding in science.
It is not the role of the FDA to limit access to a medication because some factions of society are morally
opposed to its use. If limiting access to a medication, which has been shown to be safe and effective, is
not necessary to protect public health, then it should be exempted from prescription-dispensing
requirements. [Footnote 2: See 21 C.F.R § 310.200(b).] The FDA exists to protect public health by
making evidence-based decisions; on drug safety; the agency should not allow political agendas to
substitute for science in making health decisions.
<5: 1.2.1>Evidence shows EC is suitable for OTC use
The FDA has received substantial documentation that offers clear and convincing evidence that EC is a
safe and effective drug suitable For self-medication.
Overwhelming evidence shows chat EC is a safe and effective medication whose benefits are best
realized by removing unnecessary barriers to access. This evidence has caused the American Medical
Association and the American College of Obstetricians and Gynecologists to support making EC an over
the counter medication. This support would not have been forthcoming if there were valid evidence
showing it would be inadvisable or dangerous to public health if EC could be obtained without a doctor's
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prescription.
<6: 1.2.1, 10>EC benefits
Unintended pregnancy is a public health issue that has long-ranging health impacts. Women with
unintended pregnancy forego the opportunity to receive pre-conception counseling to improve the health
of the fetus and are more likely to have low birth weight babies and experience a higher rate of neonatal
mortality. [Footnote 3: R, Bonoan and J. Gonen, "Promoting Healthy Pregnancies; Counseling and
Contraception as the First Step," Washington Business Group on Health, August 2000. ]
Increasing access to emergency contraception would play a significant role in reducing the incidence of
unintended pregnancy-a goal that would not only serve to improve the health of women and children, but
would also save money for state, federal and private insurance plans who must bear the costs of health
problems related to unintended pregnancy. A study published by New York State Comptroller Alan
Hevesi found that increasing access to EC, including making it available over the counter, would result in
122,000 fewer unintended pregnancies and 82,000 fewer abortions every year in New York. [Footnote 4:
New York State Office of the State Comptroller, 'Emergency Contraception in New York State; Fewer
Unintended Pregnancies and Lower Health Care Costs," November 2003. ] The study projected that
Medicaid costs would be cut by $254 million a year, and private insurers would gave nearly $200 million.
Making EC available over the counter would enable women to obtain the medication in a timely manner.
EC is a time-sensitive medication that is most effective the sooner it is taken after unprotected
intercourse. Making the medication available over the counter will enhance women's ability to prevent
unintended pregnancy by allowing them to obtain the medication when it has the greatest potential for
effectiveness.
<7: 1.2.1, 10>Use of EC by teens
Although concern about 'the use of EC by teens has been stated as the reason for denying the original
application and then delaying a final decision on the application to make Plan B available to women aged
16 and over, widespread support among mainstream medical organizations for making emergency
contraception available over the counter makes that assertion untenable. [Footnote 5: We note that the
most recent decision to defer a final decision on Barr Labs' application contained a reference to making
the medication available to women aged 17 and over, however, the application was for women aged 16
and over. ] Claims by EC opponents that easier access to EC will cause teens to engage in increased or
unprotected sexual activity are not supported by evidence-based studies.
Medical research shows that enhanced access to emergency contraception does not lead to increased rates
of unprotected intercourse or pose a risk to minors, A study published in the January 5,2005 edition of
JAMA found that women with enhanced access to EC are no more likely to engage in unprotected sex or
abandon use of other contraception methods than women who do not have easy access to the pills.
[Footnote 6: Raine TR et al. (2005) Direct Access to Emergency Contraception Through Pharmacies and
Effect on Unintended Pregnancy and STIs. Journal of the American Medical Association, 293( 1):54-62. ]
The article's findings are based on a study of over 2000 sexually active women aged 15-24. A similar
study also found that increased access to emergency contraception did not cause minors to engage in
unprotected intercourse. [Footnote 7: See, Gold MA, Wolford JE, Smith KA, Parker AM. The effects of
advance provision of emergency contraceptive on adolescent women's sexual and contraceptive
behaviors. J Pedaitr Adolesc Gynecol. 2004:17:87-96.]
In addition, the American Academy of Pediatrics (AAP) is supportive of increasing the availability of
emergency contraception, including over the counter access for teens. [Footnote 8: See, American
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Academy of Pediatrics Policy Statement on Emergency Contraception, Pediatrics 2005; 116:1038-1047. ]
In its position paper on emergency contraception, AAP states, "An increase in awareness and availability
of emergency contraception to teens does not change reported rates of sexual activity or increase the
frequency of unprotected intercourse among adolescents." [Footnote 9: American Academy of Pediatrics
Policy Statement on Emergency Contraception, Pediatrics 2005; 116:1038-1047.] This medical support
should dispel any myths that the medication #is somehow dangerous to a minor's health.
<8: 1.2.1, 2.3>Conclusion
Because there is no scientific basis for restricting access to teens, it would be inappropriate to consider the
questions posed in the Request for Information in conjunction with the application to approve Plan B as
an over the counter medication. In the interest of women's health and the application of scientific data, we
strongly believe the pending application to allow Plan B to be sold over the counter should be approved
without any age restrictions,
Sincerely,
JoAnna M. Smith
President and CEO
Family Planning Advocates of New York State
COMMENT NUMBER - 2005N-0345-C71
2005N-0345-C71 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ruckdeschel, Diana
2005N-0345-C71 - TEXT
I would like to share some serious concerns I have with regard to making the norning after pill available
without a prescription. Please take the following items into consideration: With regard to requiring a
prescription for those under 16 only, I worry about some very real possibilities and even probabilities that
need to be addressed. Please consider the following seven areas of concern.
<1: 1.2.3>a. What about turning 16 eliminates the need for a prescription? There have not been enough
tests showing the absolute safety of the drug for anyone, especially after repeated use. It would not be a
smart precedent to establish that prescription medication can be dispensed *without medical consent
because of age. This will open the flood gates for law suits on all kinds of drugs because people will say,
"I am old enough to decide what medications I want regardless of medical implications." You only have
to living and breathing in America to see those lawsuits on the horizon.
<2: 7.5.3>b. How can we be sure en older friend will not purchase the drug and give it to a minor? How
can we know there will not be an older boyfriend (as is often the case) who purchases the drug for a
minor girlfriend? What's worse, once a boyfriend has the drug in his hands, the pressure for a young girl
to take it can be absolutely overwhelming to her. Mark my words, there will be young girls who take it
because they are pressured by their boyfriends who will have serious regrets, There will undoubtedly be
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girls who take it against their own true wishes and against their own better judgment. Can this be
prevented by allowing only females to purchase the drug?...Not unless the FDA wants a sexual
discrimination lawsuit on its hands.
<3: 1.2.3>c. What about sexual predators who purchase it and force women and girls to take it? What
about men who will use it in conjunction with the date rape drug to eliminate the consequences of
potential child support bills? As tragic as the whole issue of rape is, we need to consider the fact that
terminating a pregnancy is not in itself a solution to the problem. There are women who, even if raped,
would not chose to terminate their pregnancies. I can say with all sincerity that even under those terrible
conditions, if I were raped, my grief would only be compounded immeasurably by the fact that a new life
who was dependent on me were taken without my consent.
<4: 1.2.3>d. We know that some will chose to rely an it as a form of birth control, considering every
sexual encounter to be an "emergency' because it will inevitably cause a decline in responsibility with
other forms of birth control, Some, especially young girls, will rely on this and discontinue using
condoms, because of this back-up plan, thereby eliminating what little protection condoms can offer.
What do we know about the effects of repeated use on women's reproductive abilities? What do we know
about the effects of repeated use on the heart? What do we know about the effects of repeated use on all
bodily systems? Excessive use could be curtailed by medical intervention.
<5: 8.6.2>e. Using different packaging would not be helpful at all. In all practicality, what it will do is
give the medically illiterate the impression that there are two different drugs, and obviously the OTC
version is safer as it does not require a prescription.
<6: 3.8.8>f. With regard to the FDA defining a regulation to allow for drugs to be available with and
without a prescription....bad idea because of the precedent it will set. Consumers will want that option
available for every drug. They will want it because of criteria other than age. Through lawsuits and
judicial action, consumers will slowly start to interfere with the FDA's ability to do its job without
"checking inn with the public. It will also undermine the FDA's credibility and authority..."Can't the FDA
decide for itself?" "Is this drug safe for 0TC use or not?...It either is or it isn't!" "'Can't they make up their
minds?"
<7: 6.5.4>g. Additionally girls, under 18 are still minors. 16 and 17 year old girls should still have their
parents included on major medical decisions. The 14th Amendment's Right to Privacy is clearly inclusive
of parental tights to parent their children which includes intervention in medical areas. For this very
reason schools and day cares are not allowed to administer Tylenol without notifying and receiving
permission from parents. Making this available to minors is a violation of the 14th Amendment where
parents are concerned.
Diana Ruckdeschel
COMMENT NUMBER - 2005N-0345-C83
2005N-0345-C83 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Alterton, Faith
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2005N-0345-C83 - TEXT
October 10, 2005
Division of Dockets Management
5630 Fishers Lane, Rm. 1061
Rockville, Maryland 20852
Dear Sir or Madam:
I am a registered nurse with emergency room experience and am concerned that the Food and Drug
Administration is considering making RU-486 also known as Plan B or "the morning after pill" available
to the public with out a medical doctor's prescription or supervision, Docket Number 2005N-0345 or
Regulatory Information Number (RIN) 091 0-AF72. I would like to respond to the FDA's request for
public comment regarding this upcoming decision.
The FDA has asked for comment on three issues:
1. Should the FDA create and define a regulation to allow for a drug to be available both with a
prescription and without?
<1: 3.2>NO. <2: 1.2.3, 7.5.3>Limiting unsupervised access to Plan B to a certain population
based on age would NOT be an effective way to stop underage adolescents from getting the drug. It
would be far too easy for an older person to purchase Plan B for a minor. Furthermore, I have serious
concerns whether Plan B should be marketed and prescribed to adolescent females at all. There is very
little research on long-term effects of this drug on adolescent patients, and particularly with those who
take it repeatedly for birth-control. Plan B is meant to be an "emergency" birth control only, and from
personal experience, I find that many patients view it as something to be used multiple times. These
patients often do not understand how Plan B actually works, only that it ''takes care" of an unwanted
pregnancy. If most patients do not even retain information explained with a prescription, the public would
be greatly at risk if offered the same drug without a doctor's advice or guidance The FDA should NOT
create or define a regulation allowing Plan B to be available both with a prescription and without.
2. Does the FDA have the authority or ability to enforce restricting a drug from a subpopulation when it
would be available to the larger population?
<3: 6.2, 7.2>NO. <4: 7.5.3>The FDA would not have the authority or ability to restrict a
drug from one subpopulation while making it available to another. Plan B might be available for SALE
without a prescription to only a certain subpopulation, but enforcing who actually takes the drug would be
impossible. It would be very easy for an 18 year old to purchase the drug herself and then give it directly
to a minor. ALL patients prescribed Plan B, need to be under the direct supervision of a medical doctor.
3. Can a drug that is approved both with a prescription for some and without a prescription for others have
the same packaging, or would it require different warning labels and instructions?
<5: 1.2.3, 8.2, 8.6.2>A drug that is marketed and sold both with and without a prescription MUST have
different packaging, labels, and instructions. The general public does not have the training to understand
important information such as side effects, contraindications, and warnings on a standard drug label. tf
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made available over the counter, Plan B needs very detailed labeling and instructions written in a simple,
easy to understand manner. However, this drug is not safe to be making available without a prescription
to ANYONE. There is simply too little research into long term effects.
<6: 1.2.3>Please consider my thoughts on this issue. They are well intention4 and from a desire to keep
the general public safe. The FDA, made a responsible decision in 2003 when it declined to make Plan B
available without a prescription. l hope that the FDA will remain firm on it's decision and continue to
make Plan B a prescription-only drug.
Very Sincerely,
Faith Alterton, RN
COMMENT NUMBER - 2005N-0345-EC1009
2005N-0345-EC1009 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rose, Demian
2005N-0345-EC1009 - TEXT
2 A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 7.5.3>not without severely restricting access to the "legal" population.
COMMENT NUMBER - 2005N-0345-EC1032
2005N-0345-EC1032 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ladd, Judy
2005N-0345-EC1032 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
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<1: 3.2, 3.8.8>To use an ingredient in both OTC and by prescription only muddies the water as to who
will receive what and in what form and intensity (dosage). It should be OTC only to assure that if
someone wants it, it's available.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product? <2: 4.1>This is unclear and opens a pandora's box of abuses by the pharmaceutical
companies.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1>Completely.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.5>It depends on whether the ruling was in favor of the population as a whole or was it to knuckle
under to the pharmaceutical companies.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law? <5: 7.2, 7.5.3>It would be impossible to regulate something that is readily available to
every other person OTC.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.6>One would incur higher costs to receive the same ingredient by prescription because they would
need a doctor's visit to get the prescription. Why would anyone want to raise the price of getting
something unless it was in some way 'improved' by the interference of a health official?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so? <7: 8.9> If another more restrictive drug were included that had side effects
that needed monitoring by a health official would be the only way that that would be feasible.
GENERAL
GENERAL
<8: 1.1>The FDA has shown itself to be a patsy for the drug companies rather than a protector of the
American public. It's time they did the job they were formed to do.
COMMENT NUMBER - 2005N-0345-EC1041
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2005N-0345-EC1041 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Speight, Thomas
2005N-0345-EC1041 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.1>The FDA should clarify all regulations so that they can be understood by the layman, and
possibilties for abuse may be minimized.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.8.1>To the extent that the same ingredient may be present in different combinations and different
proportions in prescription and OTC medications, yes the FDA should evaluate existing regulations to
ensure that the public good is protected.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1, 4.3.4>Yes, if the FDA has finally gotten around to realizing that it needs to be rulemaking.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.5>If such a rulemaking would not in any way change the intent or action of the section's language,
yes.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.5.3>It does not appear possible or cost-effective for the FDA to attempt to enforce such a law, nor
would it be in the interests of the public good to do so. There is, simply put, no good legal reason in
current federal case law or constitutional law to restrict the OTC sale of contraceptive products (broadly
defined), allergy medication, antibiotics, or other products in such a manner. Doing so would intrude
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heavily onto the issue of doctor- patient privilege and would also bring up the question of the right to
privacy as determined in Griswold V. Connecticut.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.5.1>Restricting such a product's availability would probably require new case law or revisitation of
existing precedents to determine the legality of restricting such products, as well as the FDA's authority to
do so. Given the current erosion of support for broad interpretation of the Commerce Clause, it appears
unlikely that the FDA would be able to do so in the current legal environment. Such a move would also
likely be very unpopular with the population as a whole.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 9.1.1>As the same ingredient may be present in different combinations and very different proportions
in prescription and OTC medications, it would be extremely unwise to allow identical packaging. Use of
the wrong product due to mistaken identity, or the assumption that the products are the same, could lead
to adverse reactions, injury, or death.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
see 3A
GENERAL
GENERAL
<8: 11>As a general comment, I would like to remark that the current environment of medical costs
increasing well ahead of the rate of inflation and the prevailing average wages is not sustainable for the
long term, and that both drug companies and medical providers will have to drastically restructure their
arrangements if the current economic decline continues.
COMMENT NUMBER - 2005N-0345-EC1044
2005N-0345-EC1044 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Pruis, Trisha
2005N-0345-EC1044 - TEXT
Issue Areas/Comments
1
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2>In regards to Emergency Contraception, I think having the same ingredients in birth control pills,
which are prescription-only, and EC, which is up for release OTC, is that birth control pills are long term
commitment, while EC is one time use. A person only needs to understand swallowing 1 or 2 pills at the
correct time, not everyday.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 7.4.1>I think if a law were created, it would have to be enforced at the level of the pharmacy or
doctor. <3: 1.2.1>In reference to Emergency Contraception, I don't think their should be sub-
population restrictions.
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.4.4, 7.5.3>If there were sub-population restrictions, I suppose people would have to ask for
identification with the age on it before dispensing the product. The problem with that is that not everyone
over 16 will necessarily have identification with their age on it. Many people don't get driver's licenses at
16 and would therefore not be likely to get an ID. This would create problems getting the procduct to
people that need it. Additionally, doctors and pharmacists are not going to want to add an extra step to
their work. Doctors in particular tend to be very busy. Overall, asking for identification would probably
not be practical.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.9>In reference to Emergency Contraception, I don't see why this is an issue. It would not make
sense to sell birth control pills and EC in the same package because EC is usually one or two pills and
birth control pills are usually 21 or 28. A person wouldn't need something with 21 or 28 holes for 1 or 2
pills. I think the nature of the product themselves preclude the same packaging.
GENERAL
GENERAL
<6: 1.2.1>I think safety is a first priority for any drug released OTC. Emergency Contraceptives have
been proven safe and effective for use over the counter. I think questions like how to package it are just
details. If it's safe, it should be an easy matter to package it. In regards to EC, I personally think that there
should not be an age restriction of 16 placed on it. Like it or not, people younger than 16 have sex and are
raped, and they need unrestricted access to EC as well.
COMMENT NUMBER - 2005N-0345-EC106
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2005N-0345-EC106 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Shaffer, Kathleen
2005N-0345-EC106 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.3.2>It is a contradiciton to sell an active ingredient simultaneously as a prescription drug and an
OTC drug product. Therefore the FDA has no authority to attempt to codify its interpretation of section
503(b), thereby allowing it.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>No.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.5.4>The FDA would risk profuse litigation by angry parents, such as myself!
GENERAL
GENERAL <5: 1.3>That an organization would attempt to allow general use of a drug with so many
dangerous medical side affects as the birth control pill, is incomprehensible! Surely the FDA would be
doing society a disservice.
COMMENT NUMBER - 2005N-0345-EC107
2005N-0345-EC107 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
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Commenter Organization Name: White, Molly
2005N-0345-EC107 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
What is 503(b)?
<1: 3.1, 3.8.1>Sure. Rules are great. Everyone knows the game plan when regulations exist, provided
they are short, clear and to the point.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Sure, provided a regulation is short, clear and to the point.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I'm not in a position to respond to this one. See above. What is 503(b)?
C. If so, would a rulemaking on this issue help dispet that confusion?
What is "dispet"?
<2: 5.5>Rules can alleviate confusion or they can make it worse. The nice thing about rules is they
provide grounds for further action.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.1, 6.3.5>Why not? Other agencies do. Examples: Only people who have completed medical school
are permitted to practice medicine. Only people of a certain age are permitted to vote or drive. Only
people born in the US can be president. Just because the FDA has not tried it to date doesn't make it a
particularly original or difficult problem.
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.1, 7.4.4>Yes. Just like other agencies assure that specific criteria are met before the
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rights/privileges/responsibilities associated with a certain activity are conferred upon any given
individual, the FDA should have no problem requiring, for example, that persons purchasing a molecule
show proof of identification including age and whatever else is felt to be relevant. If the local Quick Trip
can do it for me to purchase beer, then the drug store can do it for me to purchase drugs. Heck sometimes
drugs and beer are sold in the same places!
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.1>Who cares? Yes. It's as legal as you want to say it is.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 9.2.2>None.
GENERAL
GENERAL
<7: 1.2.1>My casual observation is that governments which preside over wealthy, healthy, well-educated
populations tend to encourage rational family planning. Such governments tend to act in a manner that
preserves and encourages a wide choice of family planning options. As a matter of sound economic
policy, all people should have unfettered access to whatever forms of family planning they prefer and
family planning should be highly encouraged.
Governments which restrict access (directly or implicitly) to family planning options tend to preside over
poor stupid populations. I don't want to live in a poor stupid country.
I'm aware that some people opposed to the sale of Plan B without a prescription (to anyone, let alone
women 16 or older) feel that such freedom would lead to various abuses. A person over 16 could
purchase Plan B and give it to a woman under 16, and such a purchase could occur in abusive or
otherwise unsafe situations. However, I believe that restricting the freedom of all is not the way to cope
with the unacceptable behavior of a few.
<8: 7.4.6>All freedom comes with the potential for abuse. In the case of OTC Plan B, it seems to me that
a variety of methods are available to society to address the type of abuse that Plan B critics fear. For
example, make the purchaser provide identification and take the first dose of the drug right there in the
store.
<9: 1.2.1>Another criticism is that Plan B itself is a form of abortion. My opinion is that life is a
privilege, not a right. The fact of conception does not automatically confer the right to live. The human
body destroys fetuses naturally all the time. In addition, I know too many people that have no business
bringing children into this world or attempting to raise them. By all means, allow these people to abort
their pregnancies! Parenting should not be a privilege either!
If the science indicates no sign of significant harm or inefficacy, then the FDA should allow unfettered
access to Plan B without a prescription for any person of any age. Persons who do not want to access this
family planning option may certainly make that decision for themselves. Such persons do not have the
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right to make that decision for others.
COMMENT NUMBER - 2005N-0345-EC1080
2005N-0345-EC1080 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rucker, Gwendolyn
2005N-0345-EC1080 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.3.2, 3.8.8>No. No drug should be both prescriptive & over the counter at the same time. The idea is
a contradiction and dilutes the definition of both terms. Prescription drugs indicate caution is required.
Over-the-counter items indicate public consumption. That is the mindset of the public and if you allow an
item to be both prescriptive & over the counter, then people will automatically assume the lower degree
of over the counter and assume it is for public consumption.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.3.2>Yes. The only time this should be allowed is when the active ingredients harmful properties are
made unharmful in the drug that is over the counter. If it can not be made unharmful for public
consumption, then it should be prescriptive.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1, 4.3.4>yes. there is the confusion in terminology as to the ingredient (which is the raw drug) and
the medicine (which is the compound drug). There needs to be clarfication as to when you are discussing
the ingredient drug versus the medicine drug
C. If so, would a rulemaking on this issue help dispet that confusion?
not sure
2
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A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2, 7.5.3>No. You would wind up with the exact same issues we have with alcohol & cigarettes.
Adults will purchase and give to underage people. With the issue of the Morning-After-Pill, you would
additionally have the issue of Male Sexual Predators using it as an illegal and unknown to the women
method of birth control.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 6.6.3, 7.4.1, 7.4.5>I think cigarettes & alcohol are the items that society has done this with and what
we have found out is that restricting certain types of items to adults only, only makes youth want it more
and allows those who do not care about others to profit from the youth's desire (illegal drivers licenses,
buying for minors if they pay you more). If you must do it, the way would be to follow the alcohol &
cigarettes policy. You would need to have a commission to overseee it & then the police would have to
periodically setup up sting operations at stores to make sure they are only selling the items to adults. The
stores would have to have the items behind the counter & only certain people at the store would have
access. More regulation & more money for something that could be simply regulated by making it a
prescriptiononly item.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.6.3>Legally sold in the prescription package, but not in the OTC package. Selling it in the OTC
package would remove all restrictions on the prescriptive ingredient.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 8.5.4>Selling them in OTC packages would be inappropriate. That would essentially remove all
restrictions on the prescriptive ingredient.
GENERAL
GENERAL
<8: 1.2.3>The Morning-After-Pill should never become an OTC item. First, it should never be
distributed, but if we must distribute, as a prescription is the only way. If this drug has the power to abort
a baby that has been conceived, it is too potent for public consumption. Public consumption of the
Morning After Pill as an OTC opens the doors to allow not only women to use it as a birth control option,
but men also. Public consumption of the Morning After Pill as an OTC would allow male sexual
predators to purchase it and for those whose minds are already disturbed to rationalize that it is okay to
take advantage of a women because they can give her the Morning After Pill and she will not be pregnant.
Public consumption of the Morning After Pill as an OTC would cause an increase in rapes, and child
molestation because it would allow those whose minds are disturbed enough to do those things to have a
measure of protection. Public consumption of the Morning After Pill as an OTC would cause an increase
in STD's in youth; because they often see the only consequences of having sex as getting pregnant - this
would allow them to overlook the serious consequences of STD's. Public consumption of the Morning
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After Pill as an OTC would cause an increase in pregnancies in youth; because they would intend to take
the Morning After Pill, but would forget to actually take it due to the immaturity and irresponsibleness of
youth. Public consumption of the Morning After Pill as an OTC would ultimately cost society money to
maintain the regulations, to monitor criminals, to provide for the children born to teenage mothers. While
it may seem that Public consumption of the Morning After Pill as an OTC would be freeing women to
take charge of their lives, it would actually be stunting the advance of women in society by opening the
door for women to be even more taken advantage of by sexual predators, by allowing those females and
males who are irresponsbile to maintain a level of irresponsibleness, by causing public funds to be spent
to enforce the OTC law of underage ---- when restricting the item to prescription only would resolve all of
these issues and would be less expensive for society.
COMMENT NUMBER - 2005N-0345-EC1086
2005N-0345-EC1086 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: McCormick, Michelle
2005N-0345-EC1086 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.8.8>It makes very little sense, if the drug is nessisary to the welfare of thousands of American
women, to limit and restrict the access to said drug. The FDA needs to base rules on the health & well
being of Americans, not politically motivated "interpretations" of sections and codes.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product? See above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Definitly, because I am certianly confused.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.5>Maybe so, but more than likely it will restrict the process of issuing drugs even further.
2
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A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1, 6.6.1>Sure. In California, the sale of over the counter sinus medication (used in the production of
methanphetimines) is restricted to people with an ID stating that they are over 18 years of age. This seems
to be working.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.1, 7.4.4>By restricting access based on IDs and age, or the presence of an adult, unless prescribed
by a doctor.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1, 8.4.1>Yes, because it would be nessisary to ease confusion over the two options.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.2.2>I am not sure if I can think of a situation.
COMMENT NUMBER - 2005N-0345-EC109
2005N-0345-EC109 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Burometto Jr, Charles
2005N-0345-EC109 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes
1.
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.8.2>Yes, by a creating a third class of drugs, those sold by a pharmacist without requiring a
prescription.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1>Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.1>Yes, a rule would clarify the confusion by stating what actions are to be taken.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 3.8.2, 6.1>Yes, by creating a third class of drugs for sale by a pharmacist. By restricting the sale of a
drug by a pharmacist without a prescription, the pharmacist would br held accountable to enforce the
limitation on the sale of the product.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.1, 7.4.1>Yes, Pharmacies and pharmacists are required to abide with multiple other rules and
regulations pertaining to the dispensing of drugs.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1, 8.3.1>Yes if the labelling is adjusted appropriately.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.1.1>When the directions for use are so vastly different that confusion could occur when reading the
instructions leading to inappropriate use.
GENERAL
GENERAL
<9: 1.1, 3.8.2>Multiple other industrialized nations have more than 2 classes of drugs. In this day and age
when patients are being empowered to take a proactive role in their health, safeguards need to be in place
to make sure patients are not harmed by taking inappropriate drugs. With more drugs being switched from
prescription to OTC status, having drugs available without a health care practitioner can lead to adverse
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outcomes. Some of the labeling on current OTC drugs is very confusing to a lay person.
COMMENT NUMBER - 2005N-0345-EC110
2005N-0345-EC110 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Roye, Carol
2005N-0345-EC110 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 10>There is no reason to do this in the case of Plan B. There have been well-done studies that
show that Plan B does not promote irresponsible sexual behavior by teenagers. In fact, several studies
found that giving Plan B to sexually active teens at routine visits actually encourages more responsible
condom use. I refer you to (among others):1) Raines T et al (2005, Jan. 5). Direct access to emergency
contraception through pharmacies and effect on unintended pregnancy and STIs: A randomized clinical
trial. JAMA, 293, 54-62; 2)Gold, M.A. et al. (2004). The effects of advance provision of emergency
contraception on adolescent women's sexual and contraceptive behaviors. Journal of Pediatric and
Adolescent Gynecology, 17, 87-96; 3)Roye C. & Johnsen, J. (2001). Routine provision of emergency
contraception to teens and subsequent condom use: A preliminary study. Journal of Adolescent Health ,
28, 165- 166.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 1.2.1>Not really relevant to a discussion of EC. This drug can safely be used by all women of
childbearing age.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 7.5.3>It is difficult. Think about how many teens buy alcohol and cigarettes.
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COMMENT NUMBER - 2005N-0345-EC111
2005N-0345-EC111 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Black, Jerrold
2005N-0345-EC111 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
yes
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>no
C. If so, would a rulemaking on this issue help dispet that confusion?
na
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.2>no
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 6.3.4>It seems to me that we will actually encourage disdain for the law as those selling the product
would be faced with crying 15 year-olds begging for the morning after pill to cashiers with little idea of
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what is at stake. Also, how many 17 year olds will act as a surrogate to purchase the product for a minor?
I predict the ACLU would love to make an issue about any prosecution that was attempted. An age
related ban is an unenforceable "fig-leaf".
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.5>I don't know about the legality, but I certainly wonder about future litigation when users of the
product sue for injury. Will the judge and jury look at it differently? Should they? What if it was sold
OTC to an underage patient? Does that affect liability?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
see above
GENERAL
GENERAL
<6: 1.2.4>This is an end-run around the FDA regulatory function. The health concerns in teens must be
completely addressed before this drug can be released. If this is made OTC, be prepared for school nurses
to be giving it out in large numbers with little idea of who will actually be using it. This is a litigation
disaster waiting to happen.
COMMENT NUMBER - 2005N-0345-EC1117
2005N-0345-EC1117 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ahmed , Stephanie
2005N-0345-EC1117 - TEXT
GENERAL
Please see attachment.
2005N-0345-EC1117-Attach-1.DOC
ATTACHMENT:
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 120 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 112
Agency: FDA
Docket Number 2005N-0345
Dear Acting Commissioner von Eschenbach:
<1: 1.2.2>As an obstetrician-gynecologist I am deeply concerned about the FDA's repeated delay on a
decision regarding over-the-counter approval of Plan B emergency contraception. I urge you to approve
Barr Laboratories' EC application immediately.
Currently, half of all pregnancies in the United States (about 3 million) are unintended and about 1.3
million of these will end in abortion. Widespread availability of emergency contraception could prevent
many of these unplanned pregnancies, and dramatically reduce abortion rates in the United States.
<2: 3.7.2>Under the Durham-Humphrey Amendment of 1951, the default option for all new drugs is
OTC unless the drug is addictive or dangerous when self-administered. Plan B meets all the criteria for
OTC use: low toxicity; no potential for overdose or addiction; no risk of causing birth defects; no need for
medical screening; self-identification of need; uniform dosage; and no important drug interactions. In
short, no medical reason exists for prescription status of Plan B.
<3: 2.1>In 1999, the FDA approved Plan B for the "prevention of pregnancy." In April 2003 Barr
Pharmaceuticals filed an application with the FDA to make the drug available over the counter. The
FDA's Advisory Panel overwhelmingly recommended OTC approval of Plan B by a 23-to-4 vote, after
reviewing more than 15,000 pages of clinical data from approximately 40 studies submitted with the OTC
application. Since receiving Barr Pharmaceutical's application, the FDA has at every opportunity delayed
making a decision. HHS Secretary Leavitt, who oversees the FDA, assured the Senate that the FDA
would make a decision by September 1, 2005. Instead, the FDA delayed its decision and initiated a 60-
day public comment and rulemaking process with no timetable for making a decision.
Again, I urge you to approve the Plan B EC application today-providing women with safe and effective
contraception that will reduce unintended pregnancies and abortions.
Sincerely,
Stephanie Ahmed, MD
COMMENT NUMBER - 2005N-0345-EC1121
2005N-0345-EC1121 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: White, Alan
2005N-0345-EC1121 - TEXT
Issue Areas/Comments
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1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.9.1>There is no sufficient reason to distinguish the issue of legalizing OTC Plan B over and above
that of OTC Loperamide on the basis of 503(b). Since the same general issues apply in both cases, and
OTC Loperamide was approved without raising these issues, it is unclear why these issues should be
pertinent to this case except for irrelevant moral/social/theological/political reasons.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 1.2.2, 2.1, 5.2>If there is confusion about what constitutes a safe and effective OTC drug in some
circumstances, a ruling in this particular case (Plan B) is not one that could dispel the confusion in any
significant way. Studies show that Plan B is safe and effective for the suggested target OTC population
(17+ year-old females), and thus poses no significant risk to that population (except, perhaps, in the
estimation of those commentators who import questionable and possibly unconstitutional moral or
religious assumptions about danger to embryos, as suggested above, and clearly the FDA may not
seriously entertain such concerns in its decision-making).
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.4.3>Since there is no reason to believe that the FDA has heretofore interpreted section 503(b) in a
confused way, and the case of Plan B introduces no novel issues of safety and efficacy for the target OTC
population, then there is no reason to use this case to further refine interpretation of that section. In fact,
any ruling on Plan B that further restricts the interpretation of 503(b) may well lead by parity of law to
further unintended consequences, such as rescinding the current practice of allowing equivalent-dosage
OTC drugs such as Loperamide.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.4.1>2. A./B. Since the FDA has previously ruled on OTC drugs that cannot be vended to minors
(e.g., nicotine patches), and entrusted the enforcement of said rulings to local authorities without major
incident, it is reasonable to conclude that similar enforcement of the availability of OTC Plan B is equally
feasible.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 6.6.1, 8.6.4>3. A./B. Similarity of packaging for prescription and OTC Plan B is purely a practical
matter with regard to issues of distribution of the drug, including inventory of the two modes of
dispensing the drug and the potential for illegal marketing. Some of these same problems currently are
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involved in the case of OTC pseudoephedrine, and are being resolved by local and state legislative action
to regulate that drug appropriately. Since the FDA has not seen fit to involve itself in this kind of
regulation directly, and the case of Plan B does not raise many of the serious issues of public policy that
pseudoephedrine does, there is no reason, again except for irrelevant moral/social/theological/political
reasons, that the FDA should view this case differently.
GENERAL
GENERAL
<6: 3.9.1>It is significant that the commentary on this case is solicited only in terms of the above general
questions that cover the specific issue of whether Plan B contraception should be acceptable as an OTC
drug. That implies that this case is the first such case considered by the FDA that brings these questions
forward. However, for example, the case of Loperamide, which the agency has approved for treatment of
diarrhea and is cited in the FDA?s list of dual prescription/OTC-dispensable drugs, completely undercuts
this implication. Though the FDA very finely distinguishes the prescription/OTC indication for diarrhea
in these two uses as respectively chronic/acute, each occurrence of that condition is in fact an individual
medical event, and the prescribed/OTC medication is in fact dispensed in equivalent dosage to prevent a
recurrent episode of that condition, whether diagnostically chronic or acute. Logically and medically the
use of prescription/OTC Plan B to prevent pregnancy, interpreted merely as an undesirable episodic
biological condition, is not different. Should the FDA care to challenge this claim on the basis that
potential pregnancy cannot be a medical condition comparable to diarrhea, it should equally consider
more carefully the current medical acceptability of procedures such as breast augmentation and
rhinoplasty, which are often pursued wholly on the patient?s subjective assessment of somatic
undesirability. Clearly both potential pregnancy and potential diarrhea are equivalently undesirable for
some patients, and the relevant medications are indicated chiefly for these reasons. Furthermore, if the
prevention of possible pregnancy is interpreted by the FDA as something other than an issue of patient-
assessed undesirability of a somatic condition, then the FDA would import moral, social, religious, or
political assumptions about possible early pregnancy that are of dubious scientific or logical merit to this
argument, and might well constitute an unconstitutional basis for any ruling issued by the FDA.
COMMENT NUMBER - 2005N-0345-EC1129
2005N-0345-EC1129 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Paslawsky, JoAnn
2005N-0345-EC1129 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
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drug product?
<1: 3.8.5>As a chemist, I am all too familiar with the exceptions that occur despite the industry's best pre-
marketing testing and post-marketing surveillance. Thus, I believe that it is virtually impossible to codify
interpretation of section 503(b). I believe strongly that simultaneous marketing of an active ingredient in
both prescription and OTC form must be assessed on a case-by-case basis. Otherwise, I believe both
patient safety and industry's liability are placed at major risk.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
As a chemist, I am all too familiar with the exceptions that occur despite the industry's best pre-marketing
testing and post-marketing surveillance. Thus, I believe that it is virtually impossible to codify
interpretation of section 503(b). I believe strongly that simultaneous marketing of an active ingredient in
both prescription and OTC form must be assessed on a case-by-case basis. Otherwise, I believe both
patient safety and industry's liability are placed at major risk.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2, 4.3.2>I do not believe there is confusion on this point. The FDA has worked diligently to ensure
clarity of its interpretations whenever it makes a decision. I believe the media can and often do create
confusion in the manner it reports on scientific matters in general and health topics in particular.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>No, I believe a rulemaking would simply provide additional opportunities for clouding the issue
when it is conveyed to the public.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.3.5>For those bent on obtaining a drug (whether prescription or OTC), there is ALWAYS a way to
get the drug, regardless of legal restrictions. Examples abound in this area.
However, since legal restrictions on pharmaceuticals exist largely to prevent patient harm, and such
restrictions have historically been successful, I think it would be quite logical and generally effective to
enact and enforce a prescription only requirement for a subpopulation on an OTC product.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.4.4>If, for example, the OTC product required a prescription for minors (i.e., under age 18), the
pharmacy could simply require photo ID showing DOB, such as on a driver's license. It is currently done
for cigarettes, why not a drug?
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3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 9.2.1, 9.3>Since prescription medications are provided with complete instructions, including
warnings related to possible AEs, drug interactions, etc., the OTC product should provide the same
information. In addition, if there is no difference in the formulations, including amount of the active
ingredient, then they should not require different packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.1>Different packaging should only be needed when formulations differ, including but not limited
to active ingredient.
GENERAL
GENERAL
<8: 1.2.3>As this relates to Barr Labs Plan B, I strongly believe that a decision to make this drug
available OTC creates unnecessary risk to women's health and safety. This is especially true for females
under age 18, those who cannot read or read poorly, and those for whom English is a second language. In
other words, those women already victimized and most at risk.
By approving Plan B for sale OTC, the agency, which bases its guidance and decisions on patient safety,
would place these women at even greater risk.
As an OTC drug, anyone would have access to it. This would include those trading sex with children for
drugs, those holding children in abusive relationships, and adult men (age 18 or over) preying on minor
girls. Please do not open a new door for sexual predators.
Women still suffer a stigma when reporting rape. It is even more difficult to successfully prosecute rape,
incest, and sexual abuse. Do not offer another tool to these criminals.
Those who truly care for women and their health (physical as well as emotional) would NEVER allow
Plan B to become an OTC drug for the reasons I've cited.
Studies, including those by Barr Labs itself (Jan. 2004 JAMA) have shown that easy access to the
morning-after-pill has not decreased abortions or pregnancies.
The main driver for seeking this approval is greed. Planned Parenthood stands to make $100 million
profit over a 5-year period on the sale of the morning-after-pill, provided the FDA approves its OTC sale.
Even without the OTC approval, Planned Parenthood has already made significant profit from the drug,
thanks to a partnership with Women's Capital Corporation. A year after FDA's approval of the
prescription sale, Planned Parenthood had already sold 100,000 units. When Women's Capital Corp.
asked the FDA for OTC status for the drug, Barr offered to buy the Corporation, and did so in February
2004, for nearly $21 million.
Before you make the decision, please send people to Planned Parenthood locations around the country.
See who the clients are. You will realize they are the women I mentioned earlier - poor, uneducated,
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victims.
As a woman, I ask you to PLEASE do NOT allow OTC sale of the morning-after-pill. To do so means
that the agency is ignoring the risks posed for greater sexual exploitation. I am angered by the so-called
'women's groups' who support this approval while ignoring the growing abuse of women. These same
'women's groups' NEVER use the media as widely or vehemently to demand greater funding for breast,
ovarian, or uterine cancer research, or for greater protection and assistance for single mothers and abused
women and girls.
I trust the FDA will continue to guard patient safety as its primary and highest goal. Please act to protect
women and their health - not the sexual and corporate predators.
Thank you!
COMMENT NUMBER - 2005N-0345-EC11670
2005N-0345-EC11670 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Farren, Wanda
2005N-0345-EC11670 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.9.1>FDA has precedent for simultaneous prescription and OTC usage, whether at the same or at
different doses. The nicotine patch and ibuprofen are two examples. The patch is restricted to buyers ages
18 and older.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.4.1>Nicotine replacement products available OTC are "restricted" to persons 18 and older. <3: 7.5.2>As a practical matter, enforcement appears to be up to vendors. I don't see local
drugstores listed in the paper as being in violation of underage sales, and given FDA's personnel
shortages, "enforcement" that would single out emergency contraception would reflect bias in the
agency's priorities. <4: 6.7>Either science dictates an age cutoff, or it doesn't. <5:
6.3.5, 6.4.1>In the case of nicotine replacement products, the legal age for purchase of nicotine is 18, so
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conforming labeling only makes sense. If the rule of law is cited for limiting distribution of an OTC
product, it should be consistent with relevant statutes. In the case of EC, relevant statutes might be age of
consent laws. These laws vary significantly from state to state, with the average age of consent being 14,
but as low as 11 or 12, and as high as age 18. Nonetheless, this should not stop availability to persons
who have aged out of those covered by these laws, and age 18 would be an appropriate cutoff age
nationwide.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.4.1>Leaving the product behind the pharmacy counter would ensure only certain persons get the
product, but it would also pose a barrier. <7: 6.5.4>Condoms are available OTC; there is no
age verification. <8: 7.5.3>Cigarettes are available only behind the counter, but this has not
stopped underage purchase, or purchase by older persons on behalf of those under age. Beer (and wine) in
some states is available "OTC"--and while there are requirements for age verification, it is inconsistently
done. <9: 7.4.6, 7.5.3>For a product that could be sold single-dose (or "use"), and for which
the adverse effects are exceedingly rare, it makes no sense to try to screen every possible purchaser. As a
practical matter, a purchaser under a state's legal age of consent should be reported to child protective
authorities. I seriously doubt that retailers are prepared to do this.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<10: 8.1>There would be no obvious reason why this would not be the case. <11: 8.4.1>The
burden on the manufacturer would be less. There would be no particular reason a pharmacist could not
dispense the individual product (dose of pills, whatever it is) via usual packaging for that pharmacy,
however.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<12: 8.4.1>It would be inappropriate to charge any additional fee for either package; the price should be
the same. <13: 9.2.2>I can't imagine why it would be inappropriate to have simultaneous
distribution channels, under any circumstances. This would be regulation run amok.
COMMENT NUMBER - 2005N-0345-EC117
2005N-0345-EC117 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dorn, Kellie
2005N-0345-EC117 - TEXT
Issue Areas/Comments
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1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.3, 6.3.5, 7.5.3>I agree with the FDA's initial long-standing decision that a drug should not be used
simultaneously both by prescription and used over-the- counter. It would be too dificult to enforce this
decision to make Plan B OTC only to individuals 16 or older. Many teenagers don't have a driver's license
until 17 or 18 years of age, so proof of age in itself is a problem. Also, even if the individual purchasing
the contraception is 16 or older, what is to prevent these individuals from diverting Plan B to teens who
are under 16 years of age? What is the magic age of 16 that makes this medication suddenly safe? I don't
see a huge difference in judgement between a 15 year-old and a 16 year-old or 17 year-old for that matter.
Finally, I feel that by making this emergency contraception available over-the-counter to anyone, it will
replace a visit to a doctor, which provides a valuable service. In a single visit, a doctor can screen for
STD's, pregnancy, HIV, and give a pap-smear. A patient could conceivably purchase a Plan B pack every
time that this person has sexual intercourse and never see a doctor in her entire lifetime. This will raise the
number of undetected STD's, increase the rates of undetected ovarian, endometrial, breast, and uterine
cancers, increase the number of undetected HIV cases, and prevent patients from using conventional
monthly contraceptive methods which require thought before engaging in sex and which require a yearly
physical exam. I strongly urge you to consider the points I have made and retain Plan B as available by
prescription only.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.8.4>I agree that if a medication is unsafe for some, it should remain as prescription only.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 7.5.4>I don't feel that this law is enforceable, as not every teenager has state-issued identification, and
significant diversion would occur to teenagers under 16 years-of-age.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.2, 8.5.1>No these products could not be sold in the same package, as the law requires OTC products
to comply to specific labeling requirements which are explicitly different than prescription labeling
requirements. The labeling requirements for an OTC product are designed to educate the patient on safe
use of the product, and the prescription packaging is designed to assist the health professional in
education of the product.
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B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<5: 9.1.2>It would never be appropriate.
COMMENT NUMBER - 2005N-0345-EC12
2005N-0345-EC12 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Reynolds, Charles
2005N-0345-EC12 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.1>Yes, this is an important decision for the future of health care in the US.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes, this is an important decision for the future of health care in the US.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 3.8.1, 4.5>The issue is not one of confusion. The question becomes one of establishing defined
criteria for which a drug may be used and marketed both OTC and Rx.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.7>Unknown if the FDA has the ability to regulate this under its jurisdiction.
B. If it could, would it be able to do so as practical matter and, if so, how?
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<4: 7.4.1>Yes. By creating a class of drugs that can be directly sold only by a licensed pharmacist. This
makes a specific person responsible for effectively implementing what the FDA wants. It also protects the
health and safety of US citizens by making them interact with a health care professional who can assess
the request for appropriateness as well as potential problems.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.1>Assuming there is no specific legal prevention, this would be acceptable.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 8.5.3, 9.1.1>Can't think of any problems, unless regulatory action would require special record
keeping to separate OTC use from Rx use... then separate packaging (and thus NDC code) would be
important.
GENERAL
GENERAL
<7: 1.1>This question, prompted by 'Plan B' product will become more prominent as time goes on unless
the US deals with its health care crisis.
COMMENT NUMBER - 2005N-0345-EC121
2005N-0345-EC121 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Slee, April
2005N-0345-EC121 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.8.8>No. There are two reasons to have a drug available by prescription. One is so insurance
covers it, like blood glucose test strips. The other is that a reasonable person can't be expected to take it
safely and correctly without the direction of a doctor. On this second part, either a drug is safe enough or
it isn't. Besides, anyone who is 15 is smart enough to get a 16 year old friend to buy it for them.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No. Same reason. By the way, there's a typo here.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No, I think the interpretation is reasonable and correct.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.2, 6.3.4>No way. As a teenager, you need an 18 year old friend to by you smokes, a 21 year old
friend to by you booze, and now you'd just need a 16 year old friend to buy you emergency
contraception.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.2, 8.6.2>No. Obviously you are worried that the population needing the prescription can't be trusted
to take it without the prescription, so you need warnings that address these concerns.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<5: 9.1.1>If the risks are different, you need different warnings.
COMMENT NUMBER - 2005N-0345-EC12379
2005N-0345-EC12379 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Mershon, Claire-Helene
2005N-0345-EC12379 - TEXT
Issue Areas/Comments
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1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.1, 3.1, 3.8.5>Yes. Plan B should be available OTC, and while I disagree that it should be split
between OTC and prescription, I understand the concerns of the FDA in taking the action for women
under 16. However, this should not keep the FDA from keeping it off of the shelves completely. If an
active ingredient is judged to be safe for use OTC by women, it should be sold that way. If it is necessary
to make the drug prescription for one population in order for that to happen, then the FDA should review
its rules and allow the drug to be available in both forms.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.6.3>Yes. If the age of a person buying cigarettes or alcohol is subject to legal enforcement, why
would this limitation not be enforceable?
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.4.1>One possible way to enforce this, if the FDA is worried about the populations purchasing the
drug, is to keep it behind the pharmacy counter. The only stipulation would be that there must be one
pharmacist available at all times who could not refuse to sell the drug to a customer because of its
intended use. If the pharmacy were to control this sale or distribution, they could check identification in
an area that is somewhat more private than the cash register, and they would also be available to answer
any questions a woman might have about how to use the product.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.1, 8.4.1>Yes. This would remove the burden on the part of the manufacturer to create different
packaging. In addition, the current packaging is extremely straightforward, and they have made it easy to
understand. If the current packaging works, as was ruled by the advisory committee, why complicate it
further?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<5: 9.2.1>I don't know what circumstances would make it inappropriate, but I don't believe that this is
one of them.
COMMENT NUMBER - 2005N-0345-EC126
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2005N-0345-EC126 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dougherty, Anne
2005N-0345-EC126 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Most consumers do not understand section 503(b)
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.3.2>It might, yes. Consumers look only at the availability and price of health care items. In an era
where health care is available to far fewer people at an affordable price it is vital that the patient feel he or
she is involved in healthcare decisions.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.6.3>Limiting the sale of the "Plan-B" drug over the counter is no different under the law than
limiting the sale of tobacco to people over 18 or alcohol to people over 21.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 6.6.3>Yes, I believe so. Requiring proof of age is in no way an infringement on the right to privacy.
As long as it is only proof of age, in the form of a government issued identification, that is required,
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enforcement of such a regulation could be turned over to the same agency that enforces alcohol and
tobacco regulations.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.4.1>Unless there is a dosage difference, I believe that marketing exactly the same product in
different packaging would cause undue stress to the consumer of the product. Anyone considering using
the "Plan-B" contraceptive is already facing a tough decision; packaging and marketing should not add to
any already existing impediments.
COMMENT NUMBER - 2005N-0345-EC13
2005N-0345-EC13 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Clague, Alexander
2005N-0345-EC13 - TEXT
Issue Areas/Comments
2
B. If it could, would it be able to do so as practical matter and, if so, how?
<1: 7.4.4>There are two obvious circumstances where products are limited for purchase on the basis of
age: alcohol and tobacco. If a pharmaceutical product were to be sold based on age-related criteria,
similar protocols from what are in existence today should suffice to ensure compliance with the laws. In
addition, since Plan B is not habit forming, the way alcohol & tobacco products are, some of the
restrictions on advertising which exist for tobacco would not be necessary in the case of Plan B.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<2: 3.9.1, 8.3.1, 8.7>This is an odd question, since omeprazole (brand name Prilosec) is currently being
sold both as a prescription and as an OTC product. The distinction that the OTC product is a different salt
than the prescription product has no biologic significance. Accordingly, the same package may be used so
long as the "OTC" product contains whatever required language the "prescription" product would require
so that there would not be any problems where a pharmacy were "out of stock" of the prescription product
while still having an inventory of the OTC product.
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B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<3: 9.3>only if the "package insert" information is not available for the "prescription" sale.
GENERAL
GENERAL
<4: 1.2.2>Plan B is safe and should be sold over the counter. If young girls are required to obtain a
prescription for it, the packaging should be created to ensure flexibility regarding the type of sale so that
there are no inventory "shortages" for either the OTC or prescription sale.
COMMENT NUMBER - 2005N-0345-EC13026
2005N-0345-EC13026 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Thomas, Tiffany
2005N-0345-EC13026 - TEXT
Tiffany N. Thomas
Paper Assignment
Political Science 3700
October 31, 2005
ANPRM published in the Federal Register vol 70 no. 169, pages 52050-52051;
Docket No. 2005N-0345 and/or RIN number 0910-AF72,
<1: 7.5.3>In response to the Advance Notice is Proposed Rulemaking, about what types of drugs should
be sold simultaneously both by prescription and over the counter, and it has major implications for the so-
called "Plan B" emergency contraception. I think that all drugs should only be available through
prescription or over the counter and not both. In my opinion it is absurd to have both. Like many others I
think there is no point in going to the doctor and when one could just go to their local CVS or Eckerd and
buy the same thing they are getting with a prescription over the counter. <2: 3.11>Another
issue I have with having both is will the dosage be the same. If you are going have both, then the amount
of the active ingredient should be less in the over the counter drugs.
<3: 3.8.4>According to Lester M. Crawford at one time the Federal Drug and Administration "used to
prohibit products from being sold both over the counter and prescription at the same. The idea was if an
active ingredient was safe and effective with out practitioner's supervision it had to be over the counter."
I think that is a major reason that drugs should only sold either over the counter or by prescription no
simultaneously. Prescriptions have physician advisory; your doctor can control the amount of the drug
you receive and how often you receive it. Whereas, with the over the counter you are only consulting
your pharmacist, who does not know you medical history and can not adequately make sure that it is safe
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for someone's particular body type. This could be dangerous and harmful to your health. Also, with
prescriptions somebody can keep track of how much you receive and you can only get the amount that
your doctor has prescribed. When a drug is sold over there is no way for you to keep track of who gets
what and how much. With drugs such as the "Plan B" drug there would need to be some sort of data base
to keep track of who purchases, so that people could not abuse the system, and go from store to store
every other day and be like I need this pill. There should a limit on how much you can receive with in a
certain time frame.
<4: 3.11>Another big factor in determining whether drugs should be sold in both prescription and over
the counter is the amount of the active ingredient that is in the drug. If the drugs are going to be sold
simultaneously then the dosage should be different in the over the counter drug than it is the prescription
drug. That way people could not abuse the drug. In regards to the "Plan B" drug lowering the dosage
and selling it in a single package would be essential in making sure that women do not act irresponsibly
and try to take multiple dosages of the drug.
<5: 7.5.3>One of the questions regarding the "Plan B," drug is "should age by a criterion on which we
decide whether a drug is sold as a prescription product, or an over-the-counter product…how as a
practical matter, would such a limitation be enforced." This is a big question and is one that is difficult to
answer; we can not fully enforce keeping kids from smoking and drinking so how can someone enforce
keeping underage girls from gaining access to this drug. I think that if the "Plan B" pill is sold by
prescription only then it would make it harder for underage girls to get. With a prescription the girls will
have their doctor's supervision and it will adequately prescribe to their particular body type. When it is
sold over the counter to older girls the younger teens will just ask their friends who are of age to go and
buy it for them the same way in which they do other things they are to young to buy for themselves.
Another major reason that it drug should be sold by prescription only is there would be no way to really
enforce the age limit, girls could get fake identification and then what would be the point, with a
prescription then the pharmacist knows who the person is and what their real ages.
<6: 7.6>Furthermore, how would this affect insurance? If the drug is sold over the counter how would
this affect your insurance; would your insurance provider tell you to buy the over the counter version
instead of the prescription version of the drug? If you sold the drug both over the counter and by
prescription, then I think the over the counter version should be more costly than the prescription this
would also prevent people from misusing the drug. If the over the counter drug cost more than the
prescription then people would be more careful and would take the time out to go to the doctor and get a
prescription instead of just going the pharmacist.
<7: 3.11>There is no reason for a drug to be sold over the counter and by prescription simultaneously, it
is absolutely pointless. It should be sold either by prescription or over the counter not both, there is no
way that you could regulate how much a person receives and how often if it is sold both ways. When a
drug such as the "Plan B" pill is sold both ways there would be no physician advisory for the people who
received the drug over the counter there would be no way to tell what the effects were on their bodies this
could possibly be dangerous to our society. Many may argue that this is a good idea especially in special
circumstances like rape, because then the drug will be very assessable in a limited amount of time.
However, I do not think that it is even a good idea in special circumstances such as rape, because once
again this would cause people to not to see their physicians who can adequately tell what is right for a
particular body type. When something is sold over the counter it can be misused easier than prescription
drugs and there is no way to limit and record who takes it and how much, therefore all drugs should be
sold either by prescription or over the counter. <8: 1.2.3>The "Plan B" is one of those drugs
that should be sold only by prescription and not over the counter.
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COMMENT NUMBER - 2005N-0345-EC13197
2005N-0345-EC13197 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Chihane, Ziad
2005N-0345-EC13197 - TEXT
GENERAL
See Attachment
2005N-0345-EC13197-Attach-30.DOC
ATTACHMENT:
Ziad Chihane
3027 Henderson Mill Rd.
Atlanta, Ga 30341
Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in
Both a Prescription Drug Product and an Over-the-Counter Drug Product.
Agency: Food and Drug Administration, HHS
Action: Advanced notice of proposed rulemaking.
Docket No. 2005N-0345
RIN: 0910-AF72
<1: 3.1, 4.1, 5.1>The rulemaking in question is of utmost importance in regards to health and safety of
citizen of the United States. The FDA should absolutely initiate a rulemaking to codify its interpretation
of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a
prescription drug product and an OTC drug product. The act in itself is unclear and with the high degree
of importance that medicine serves to citizens it is imperative that there be rulemaking in regards to this
issue. The confusion that occurs with the FDA's interpretation of section 503(b) is that they have set
limits in the amount of dosage that something can have depending if it is OTC or a prescription drug. But
this is not very clear this is why I believe that FDA should go into a more effective rulemaking process to
better regulate this issue. The way that the rule is currently setup I believe leaves a lot of room for
speculation, which is not something that needs to be done with prescription or OTC drugs. If we don't put
a more effective rule on the section 503(b) it could eventually get out of control. So yes I do believe that
rulemaking on this issue would dispel the confusion that is along with this section 503(b).
<2: 6.1, 7.3.1.1>The FDA like other Federal administrations has many processes to ensure that the rules
that they make and administer are followed. So if the FDA does continue with rulemaking in respects to
the section 503(b) they would certainly be able to enforce the rules that have been made. As long as the
FDA makes the law so that it is constitutional then there should not be a enforcement problem in respects
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to the rules made. I think that this would be somewhat of an easy thing to control because the
enforcement would be on a broad level. The FDA would have to regulate the pharmaceutical companies
by telling them how the product will be distributed and then the pharmacies that distribute the drugs will
only do so if a licensed practitioner prescribes it. Although this would be more difficult if the rulemaking
affected drugs that where previously OTC and then they become prescription drugs. This I believe would
cause a problem in regards to enforcement because people will be upset over the new rule but in the end
the new rule will be more effective. The rulemaking enforcement would be practical from a forward
perspective clearly it would take a while for companies and pharmacies to change in respects to the new
rules but it would be done and it will be affective.
<3: 8.2, 8.9>With the new rulemaking if the prescription and OTC product are going to be allowed to be
sold they should not be sold in the same package. Depending on what you need the medicine for if they
are packaged together this may lead to abuse of the product and that would clearly not be the purpose of
the rulemaking. I don't agree with the being sold in the same package but if it was to do so I believe that
it would be inappropriate if the packaging didn't clearly state the differences between the two different
levels of drugs that would be contained inside the packaging. I also think that it would be inappropriate to
package the two drugs if they had side effects that may be different depending on the dosage cause I feel
that this would also lead to abuse.
<4: 4.1, 8.2, 8.6.2>Overall I don't believe that drugs should be packaged together or that there should be
higher doses that could be taken without a practitioner to determine the level of drug that is needed.
Drugs are a serious problem in the United States and if the FDA loosens up the restrictions on higher
dosage drugs then this will lead to a more abusive situation in regards to prescription and OTC drugs.
Also I do believe that if this was done it will take away some of the professionalism from the health
professionals and people will self medicate without the proper knowledge and this could lead to serious
side affects. Clearly there needs to be a more clear interpretation of the section 503(b) so that it is more
effective clear and most importantly that it will have safe rules for people. If this can be done the FDA
has done their job on this matter.
COMMENT NUMBER - 2005N-0345-EC132
2005N-0345-EC132 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Peters, Jeanette
2005N-0345-EC132 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.3, 3.8.5>It is logical to update codes to include provisions for the simultaneous marketing and
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selling prescription and OTC drugs. This is especially clear in a case where age is the deciding factor:
adult users should not have road blocks put in their way when they seek to buy safe, legal medication.
Consider: we do not need a prescription or other form of authorization to buy alcohol, though its selling is
age-based. In the case of medication, the issue of accessibility can be much more critical: patients rarely
have a chance to get a prescription over the weekend, for example, and some medications are heavily
time-sensitive.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
It is logical to update codes to include provisions for the simultaneous marketing and selling prescription
and OTC drugs. This is especially clear in a case where age is the deciding factor: adult users should not
have road blocks put in their way when they seek to buy safe, legal medication. Consider: we do not need
a prescription or other form of authorization to buy alcohol, though its selling is age-based. In the case of
medication, the issue of accessibility can be much more critical: patients rarely have a chance to get a
prescription over the weekend, for example, and some medications are heavily time-sensitive.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1, 4.3.4>Significant confusion exists, especially in light on concerns that section 503(b)'s criteria
may unfairly and negatively impact accessibility to legal and scientifically-validated medications.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 3.7.1, 5.1, 5.3.1>Rulemaking, in accordance with ADA section 553, is needed as a matter of public
health via increasing accessibility to safe, legal medications and removing the unfair burdens currently
upon consumers.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.6.3>Analogously to the ATF and tobacco/alcohol regulations, a limitation on availability to a
subpopulation could be enforced.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 6.6.3, 7.4.4, 7.4.6>Insomuch as any other law may be practically enforced, the FDA would be able to
enforce regulation concerning availability to a subpopulation. As with other agencies' laws, a large pool
of enforcement possibilities exist. On the front end, consumers regulations can require that customers
prove their age, as with alcohol and tobacco purchases. On the back end, penalties including but not
limited to fines and eventual closure of offenders' operations have been used to enforce agency laws.
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3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.6.2, 8.6.4>Assuming that it is legal to market the same active ingredient in both a prescription and
OTC product, product labeling remains an issue very distinct from the allowing for availability of a
product to a subpopulation. The FDA should seek a removal of barriers on consumers that impede their
access to safe, legal medications, especially when these medication are time-sensitive in nature. While
diverse labeling costs the manufacturer somewhat more, labeling OTC products differently from
prescription products when both are simultaneously available will facilitate in avoiding customer and
seller confusion, and allow for easier enforcement of regulations concerning sale to a subpopulation.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 8.5>As discussed previously, ease of enforcement and concerns about vendor and/or customer
confusion would warrant selling the products under different labeling.
COMMENT NUMBER - 2005N-0345-EC135
2005N-0345-EC135 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Severance, Peter
2005N-0345-EC135 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.8.8>No. Why are you complicating this? The FDA is supposed to regulate drugs based on
clinical evidence, not make social policy.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
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Is this a mistake? You have two Issue Areas marked 1 A -- with slightly different wording...both of which
seem to be grammatically incorrect and/or contain spelling errors?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1, 4.3.4>Yes. Unfortunately, it is the FDA which has created the confusion. If there is clinical
evidence that a significant portion of the target population may be adversely affected by dispensation
under non-prescription protocols, then the drug should only be dispensed as a prescription drug.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>No
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.5.4>Irrelevant. The FDA would be creating an overly-complicated system of enforcement.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.5.4>Irrelevant. The FDA would be creating an overly-complicated system of enforcement.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
Irrelevant. The FDA would be creating an overly-complicated system of enforcement.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
Irrelevant. The FDA would be creating an overly-complicated system of enforcement.
GENERAL
GENERAL
<6: 3.8.4, 3.8.7>You should not be growing a government bureaucracy in order to achieve someone's
idea of social policy. If a drug carries clinically proven risks to the affected population, it should be
dispensed only by prescription. Period. End of story. Don't play games with drug regulation. The agency's
credibility is already on shakey ground.
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COMMENT NUMBER - 2005N-0345-EC13643
2005N-0345-EC13643 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kwak, Eugene
2005N-0345-EC13643 - TEXT
GENERAL
see attachment
2005N-0345-EC13643-Attach-33.TXT
ATTACHMENT:
Eugene Kwak
3078 Devauden CT
Duluth, GA 30096
Comment on Notice of Proposed Rulemaking
FDA
Docket #: 2005N - 0345
The benefits that may arise from selling some prescription only medicines over-the-counter as well to the
end-user consumer are greater than any possible affliction it may cause upon society. For instance it
allows for better accessibility, raised competition amongst businesses, and promotes the idea of free
choice and personal accountability. There are, however, many possible drawbacks if this were to happen,
but the benefit makes it a greater need.
<1: 3.9.1>One may argue that if pharmaceuticals were placed as an over-the-counter drug, it would allow
abusers to gain easier access to a substance. Well, naturally the FDA would be drawing a line as to what
is and what isn't going to be sold in both market areas. Drugs such as hydrocodone, a powerful painkiller
and opiate, would not move from its prescription-only status, naturally due to its potency and highly
abusive properties. There are already drugs being in both areas, even today. Acetaminophen, Tylenol's
active ingredient, is sold in its original non-prescription form and in prescription strength. What is the
difference between the two and why is Tylenol given such treatment? Acetaminophen, unlike
hydrocodone, is not highly addictive and doesn't have a likelihood of being abused. Also, the non-
prescription form is roughly one-third the amount of acetaminophen per pill. So, if we were to avoid the
problem of abuse, then a line should be drawn as to what can and what cannot be moved to the
shelves.
<2: 3.8.3>Accessibility would be such an advantage to almost every person there is. Not everyone can go
to a doctor at 12am midnight to get a prescription for some powerful nasal decongestant when that person
needs it. If the prescription strength nasal decongestant was moved down to the over-the-counter level, it
would be available to the person at all times. Also, the less fortunate low-income families would be
allowed greater access to medicines as well. Doctor fees are expensive and many of the country's poor are
unable to pay these fees and receive proper treatment or medication for their problems, simply due to
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being unable to pay the costs. If some medicines moved over-the-counter, even these people would
benefit for having access to the drugs without the hefty doctor fee.
Moving medication to the shelves can also heighten the level of business competition. It would increase
the market size that these companies can sell to. This would make more companies strive harder to reach
this market at even further horizons. An initial effect and end effect would be the lowering of costs for
medications for the end-user consumer as well. Also, if companies are doing better here, that shows in the
status of the country's economy as a whole, so I cannot see where we are being hurt on this matter by
going through with this process.
<3: 3.8.3>America's governing principle is that of liberty, which is also being able to choose and take
accountability and responsibility in your actions and the choices you decide to make. So how would
moving medicines over-the-counter promote this ideology? Well, if the people aren't able to choose what
they can and cannot do for themselves, then isn't that a lack of liberty? Currently, the liability and
accountability, for the use and sales of prescription medicines is placed largely on the doctors who
prescribe them. If they were to prescribe a patient the wrong medicine, then that doctor would be facing
some form of punitive measure. If people were allowed to choose for themselves what is best for them,
they would simply be taking liability and responsibility for their own actions. This is the first fundamental
step to liberty. People should be able to choose whether or not to take some medicines if they felt the need
to be treated.
<4: 3.8.3>What should the FDA do? I believe the FDA should follow through with this rule, but make
sure there is some form the threshold in place to insure that highly abusive substances, such as
hydrocodone, be kept out of the open market and behind the counter as it is today. However, going
through with the process would enhance accessibility of the medicines to anyone in need, business
competition would be heightened, the idea of personal liberty and accountability would be nothing but
promoted to a greater degree. These are but a few of the reasons as to why the FDA should follow
through with this rule.
COMMENT NUMBER - 2005N-0345-EC13845
2005N-0345-EC13845 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rahl, Michael
2005N-0345-EC13845 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
There is sufficient reason for the FDA to initiate a rulemaking to codify its interpretation of Section
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503(b) as to when an active ingredient can be simultaneously marketed in both a prescription drug
product and an OTC drug product because the lack of legislation has created interpretations that have had
some success but whose scope is not broad enough to address concerns that arise outside of their margins
that focus primarily on the safety to the consumer. In the absence of such codification we find misspent
FDA resources, delay on the marketing of certain drugs, a consequent profit loss by pharmacies and
pharmaceutical companies, and specific needs of members of our society have been put on hold while the
FDA balks in this decision making process. In codifying the aforementioned interpretation of section
503(b), the FDA could maximize its procedural efficiency and increase its service level output to the
nation which would generate broader levels of satisfaction to society?s needs.
2005N-0345-EC13845-Attach-34.TXT
2005N-0345-EC13845-Attach-35.DOC
ATTACHMENT:
Michael Rahl
7931 Roswell Road Apt. F
Atlanta, GA 30350
Food and Drug Administration
Docket: 2005N-0345
<1: 3.1, 3.8.1>There is sufficient reason for the FDA to initiate a rulemaking to codify its interpretation of
Section 503(b) as to when an active ingredient can be simultaneously marketed in both a prescription drug
product and an OTC drug product because the lack of legislation has created interpretations that have had
some success but whose scope is not broad enough to address concerns that arise outside of their margins
that focus primarily on the safety to the consumer. In the absence of such codification we find misspent
FDA resources, delay on the marketing of certain drugs, a consequent profit loss by pharmacies and
pharmaceutical companies, and specific needs of members of our society have been put on hold while the
FDA balks in this decision making process. In codifying the aforementioned interpretation of section
503(b), the FDA could maximize its procedural efficiency and increase its service level output to the
nation which would generate broader levels of satisfaction to society's needs.
<2: 3.9.1>The FDA has deemed it appropriate to market the active ingredient in both formats under four
conditions: indication, strength, form of dosage, and the manner of product administration. The impetus
for these four criteria and the permission to market dual forms of an active ingredient that has varying
formula constitutions have been based on the relative safety of the individual that is using the products. A
drug such as Meclizine, which in its prescription form is used to treat vertigo and nausea in its OTC form,
was tested and deemed to be safe for public consumption in either of the two forms. If one were to
examine several of the other drugs that have been evaluated in a similar fashion by the FDA, they would
witness the development of a theme which binds this accepted category together: these drugs are not
ethically, morally, or normatively questionable to society.
<3: 1.2>Why should social values be mentioned at all? There are new classes of drugs that are emerging
whose utilization challenges the moral consciousness of an influential and conservative sector of
America. A case in point is the drug Levonorgestrel, or Plan B, that was created by Barr Laboratories.
After The Center for Drug Evaluation and Research (CDER) completed its review of Barr's amended
application, it scientifically concluded that the drug was safe to use as an OTC product for women who
are 17 years of age and older. Still the FDA is unable to reach a decision on the acceptability of the
application because it contends that it has never determined whether a drug may be simultaneously
prescription and OTC based on the factor of age, it questions how the an age minimum could be enforced,
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and it has not dealt with the issue of versions of the same active ingredient being marketed in a single
package. These newly emergent issues do pose as a legitimate policy oriented challenge to the FDA, but it
cavaliers this as a façade because it is overwhelmed by the extraneous pressure exerted on it from morally
conservative groups that have political and economic clout in the United States.
<4: 3.8.1>In codifying its interpretation of section 503(b), the FDA will need to include direct and
coherent policy statements that diminish the incomprehensive rhetoric that it currently ascribes to its
decision making in section 503(b). The agency should present a multifaceted application that is capable of
addressing the contemporary drug product needs of subpopulations such as young adults, that advises
pharmaceutical companies of their responsibilities to the FDA in receiving its approval for the less
mainstream drug products, that prescribes to the pharmacies and doctors exact procedures as to how and
to whom they will distribute these products, and the FDA should refine and make available to anyone
concerned their own internal procedures and time frames under which occur the approval processes for
such drugs.
<5: 7.4.4>In the previous section one of the numerous recommendations touched upon the issue of
distribution of medication. This is an issue of key importance that might very well merit more
consideration and analysis than the issue of codification. Several questions that will now be addressed
have arisen around this precept that pertain to dispensing the products to subpopulations as prescriptions
only, enforcing this restriction, and the practicality of doing so.
The FDA has to distinguish between the prospective populations that will be purchasing the drug products
by delineating them as minors from adults. Let the tobacco sales legislation be a framework for which the
sale of drug products will follow suit. If the individuals are at least eighteen years of age, they should be
allowed to purchase the same active ingredient as a prescription or as an OTC drug free of age restriction
guidelines. If the individuals are minors, they should not be prohibited to purchase the active ingredient in
its OTC form. They must be restricted to the active ingredient on a prescription only basis whereby they
will be required to first have the consent of their legal guardian and if they cannot obtain this, then they
may purchase the drug independently provided that the licensed professional has made a valid attempt to
notify their guardian to make them aware of the situation.
<6: 7.3.2, 7.5.3>The second condition has limitations but it is a proposal that functions on a basis that can
negotiate, head on and realistically, the challenges that confront the FDA and those that are charged with
prescribing and selling prescription drugs. An inevitable reality is that subpopulations will need
reproductive and other nontraditional drugs. Another issue is that there might be circumstances where it is
impossible to directly contact the legal guardian for consent or to inform them of what is transpiring.
Finally, if an individual needs a drug product, and this will hold true especially in cases of emergency for
the individual, there is no amount of legislation or enforcement that can prevent the individual from
obtaining what they want. This would suggest that the FDA limit its attempts at enforcement and allocate
its financial resources to education which proves to be more effective than policing. Reference the "War
on Drugs" for a more accurate presentation of how the combatant attitude is ineffective as we still have
the largest drug epidemic in the world. To reiterate, the second principle that applies to minors requires a
minimal awareness contact by the licensed professional to the legal guardian and the drug must be on a
prescribed basis. This idea is essential because in effect it says: "As a morally responsible society, we
recognize that we have an obligation to regulate the privilege of the subpopulation purchasing these drug
products, absolute control is not a possibility and is counterproductive to our agenda, and we will not
endanger their wellbeing nor deny them of their civil liberties by some authoritarian stranglehold."
<7: 3.8.1>If the FDA were to formulate policies based on the general principles mentioned here in the
codification of its interpretations and in the principles of regulatory distribution, if it were to align itself to
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the needs of a more contemporary America, and if it could stand firm and make decisions in the face of its
opposition, it would function as a far more effective federal agency.
COMMENT NUMBER - 2005N-0345-EC13851
2005N-0345-EC13851 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Nguyen, Marie
2005N-0345-EC13851 - TEXT
GENERAL
For the action of the advance notice or proposed rulemaking, a request to the public for comments on the
issue confronting the FDA whether or not to initiate a rulemaking to codify it interpretation of section
503[b] of the Federal Food, Drug and Cosmetic Act, regarding when an active ingredient may be
simultaneously marketed in both prescription drug product and an over-the-counter drug product. With
that question, being proposed, other minor concerns arise from this proposal. <1: 3.1>Addressed in this
comment are the reasons why I believe there should be an imitative in rulemaking and following are the
comments on certain concerns.
<2: 3.8.1>The FDA should initiate a rulemaking to codify it interpretation of section 503[b] of the act
regarding when an active ingredient can be simultaneously marketed in both a prescription drug product
and an OTC drug product. With the dichotomous description of the prescription drug and OTC, there
have been problems with the interpretation of section 503[b]. In initiating this rulemaking, the benefits
would include a simple interpretation of the prescription drug and the OTC drug?s meaning, and a more
absolute guideline for the FDA to use to regulate the drugs. <3: 4.1>There is significant
confusion in regarding the FDA?s interpretation of section 503[b]. <4: 4.3.3>The act does not
define OTC drug. This has caused the confusion over what can be marketed and hence the debate over
which drug can be available in both fields.
<5: 5.1, 5.3.2>A rulemaking would be the key to help dissolve the confusing language in section 503[b]
of the act. With an adjustment and a revision to the language brought on by the rulemaking, this would
allow an easier interpretation of the meaning of what constituents a prescription drug or an OTC drug.
<6: 6.1>The FDA would be able to enforce the limitation as a matter of law to the sale of OTC product to
a subpopulation. <7: 6.6.3>Anything can be enforced with the use of law. A clear example is the
controversy concerning Plan B. There is a concern regarding the ability to regulate the purchase of Plan B
if made OTC to the subpopulation, which would be women under the age of 16. The regulation still
allows for Plan B to be available, but if you are of the subpopulation, the purchase would be through
prescription rather than OTC. This enforcement would be similar to cigarette sales. <8:
7.1>The enforcement can be a practical matter. <9: 7.4.4>It would be as said above, similar to
cigarette sales. There would be an enforcement such as age limits to a certain OTC drug. Purchases would
be prohibited for OTC drug if that individual does not meet the limit. <10: 7.4.5>Other
enforcement would be setting heavy fines or penalties to deter purchasers to purchase OTC drugs if they
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do not meet those limitations.
<11: 8.3.4>If the prescription and OTC drug were able to be marketed in the same label, I believe that
there is no harm and that it can be legally be sold with the same package. Furthermore, the package would
have to display accurate information of the drug, such as the dosage or strength of the drug.
COMMENT NUMBER - 2005N-0345-EC141
2005N-0345-EC141 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Connors, Meaghan
2005N-0345-EC141 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes. Doing so would move this prolonged, highly politicized process.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes, as answered above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Confusion at best, disillusionment at worst.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>Hopefully.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
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<4: 6.6.3>Absolutely, a prescription would not be necessary. No prescription is required for cigarettes or
alcohol or lottery tickets, and those items are available only to specific populations.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 1.2.1>Individuals over the age of 16 should be able to freely purchase this safe, important product.
This product will undoubtedly prevent countless abortions and medical complications.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.4.1>If they are in fact the same product with the same specifications, I don't see the relevance of
this question.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.3>This seems to be an unnecessary question; perhaps any implications by having the product sold in
a single package should be further explicated by the FDA, as this is the FDA's area of expertise.
GENERAL
GENERAL
<8: 1.2.1>I am grateful to Dr. Woods for taking a stand. Commissioner Crawford's latest 'action' on Plan
B, which is actually a lack of action, is most disconcerting and sullies the FDA's reputation, in my
opinion.
COMMENT NUMBER - 2005N-0345-EC14261
2005N-0345-EC14261 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Owens, B
2005N-0345-EC14261 - TEXT
GENERAL
<1: 4.3.3>This submission is in response to FDA Advanced notice of proposed rulemaking of Docket
number 2005N-0345. It is quite apparent that the issue that is in contention now has obviously been one
of great controversy for quite some time now. Upon submission of the Federal Food, Drug, and Cosmetic
Act, there was already confusion as to which drugs were acceptable for public use without the supervision
of a licensed medical practitioner and which drugs were not. Section 503(b), which was enacted in 1951,
was the attempt to remedy the aforementioned confusion. The apparent problem with section 503(b) is
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that it attempts to regulate any product which we now term as an OTC drug, but in doing so fails to give a
clear definition of the term. In fact, the term OTC is missing from the section altogether. In solving the
problem and answering the questions put forth for submission, the most obvious remedy comes in the
form of precedent. The key question is whether or not an active ingredient can be simultaneously
marketed as both prescription drug and OTC. Several drugs that have been released over the years have
done so, but only when a meaningful difference exists between the two products, (i.e. ibuprofen given at
400+mg for arthritis but given at 400mg and below for aches and pains). <2: 6.5.2>The FDA
has yet to approve a drug for both OTC sale for one population and prescription in another population, but
the biggest question is why? Obviously there are legal issues associated with such a drastic shift in the
policy of public administration of drugs, and it should be apparent for one simple fact: time. It is apparent
because of the length of time that this issue has been debated. Section 503(b) was introduced in 1951, and
has remained the standard for the last 50+ years not because the policy was written so well and works so
effectively, but because it is simply not possible to accomplish the aforementioned task of dual marketing
to OTC and prescription population on the basis of age alone.
<3: 6.5.2>The most prominent advocate of this theory is the Plan B drug. The drug was proposed for
marketing to both OTC and prescription patrons based on age restrictions. The makers of Plan B want to
make the drug available for OTC sale to women age 16 and older, but simultaneously make it available to
women under the age of 16 by prescription only. The problem with this is that there is not significant
evidence in the research presented by the drug maker to show that women under the age of 16 can safely
use the drug without professional supervision of a practitioner licensed by law to administer the drug.
Also, it is furthermore obvious that this burden of proof is too great for the drug maker to handle, due not
only to the fact that new studies of the drug have not been released since the initial submission of the new
drug application on April 16, 2003, but also to the significant fact that a follow up proposal was made
more than 30 times over the course of about a year.
The burden of proof is too great to be tackled at this time. Precedent has made it more than obvious that
dual marketing of a drug on the basis of a difference that cannot be shown as being a meaningful bar of
separation is not possible. It could not legally be done due to the fact that any active ingredient
administered to one population by prescription and to another population OTC without meaning
difference proven by research would be viewed as discrimination. Therefore sale of any drug to one
individual over another without a proven valid basis is illegal.
<4: 8.1, 8.4.1>Furthermore, the question of whether or not the drug should be marketed in the same
packaging OTC and by prescription is technically a waste of time. . If a prescription box of an active
ingredient was given to a patient, then they acquired an OTC box of the same active ingredient, there
would be no meaningful difference in the patient choosing to use one box over the other. Having two
packages for the same item is not necessary.
COMMENT NUMBER - 2005N-0345-EC14388
2005N-0345-EC14388 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Soriano, Lauren
2005N-0345-EC14388 - TEXT
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GENERAL
"See Attachment"
2005N-0345-EC14388-Attach-37.TXT
ATTACHMENT:
Lauren Soriano
1257 Raleigh Way
Lawrenceville, GA 30043
In response to dual approval for prescription and over-the-counter pharmaceuticals, Docket No. 2005N-
0345:
<1: 2.2>Since the Food and Drug Administration cannot decide whether or not to approve the selling of
Plan B as both a prescription and over-the-counter drug, the action of taking an advanced notice of
proposed rulemaking is a good idea. If any agency is having problems with deciding whether or not to
initiate rulemaking, an ANPRM should be taken immediately. However, the Food and Drug
Administration does have evidence and recommendation from the FDA staff regarding the approval of the
drug, which makes the ANPRM seem pointless. But since the FDA commissioner, Lester M. Crawford,
seems to take the politics behind the Plan B drug into account, an action should take place because neither
the staff of the agency, such as Susan Wood, nor the public wants any more delay with rulemaking.
Seeing that the Plan B, emergency contraceptive, is such a sensitive issue, the FDA should look and take
every aspect into account due to the consequences one decision could have on a lot of people, especially
women.
<2: 3.1, 3.8.3>The Food and Drug Administration should initiate rulemaking in order to see if an active
ingredient can be simultaneously marketed in both a prescription and over-the-counter drug. However,
there has to be stipulations on the over-the-counter drug because if the same active ingredient is in both
the prescription product and the over-the-counter product, then what would be the purpose of a
prescription drug. People would just flock to the OTC drug, since it is so accessible. <3:
5.3.2>Also, Section 503(b), the active ingredient segment, should be more clear and cohesive so that
there is no confusion regarding the interpretation of that section. The only way to ensure that section
503(b) would change is if rulemaking is put into affect. No drastic change in the section would be taken
seriously without rulemaking approved by the FDA. <4: 3.9.1, 6.3.4>If the FDA did approve
of the selling of Plan B as both a prescription and over the counter drug, they would have to make
stipulations. Limiting the sale to a particular subpopulation should be one of the stipulations that the
over-the-counter product should have. Just as other OTC products like flu medicine are sold, Plan B
should be sold to women age eighteen years or older and remain as a prescription for others that are under
the age of eighteen years old. Much of the controversy lies on whether or not to market the drug to
women sixteen years or older, but seeing how women are not even close to being fully developed at age
sixteen, the drug should not be available to them because they are more likely to use the drug improperly.
<5: 7.3.1.1>Another way to regulate the distribution of Plan B is to put strict rules behind the buying and
selling of the over-the-counter product, and then women would have to take the drug more seriously. <6: 6.6.3>The agency should use the same process of enforcement as tobacco products because
there are strict rules and regulations that distributors have to enforce or they would be out of business. If
the Food and Drug Administration uses the same plan of action with the over-the-counter product of Plan
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B, then more people will understand the seriousness of the drug.
<7: 7.4.6, 8.6.4>Furthermore, one stipulation for the over-the-counter drug is not enough. If girls really
needed the emergency contraceptive, they would find ways to get the OTC product even if their not
eighteen years old. The over-the-counter product should be marketed in a single package and at a higher
price than the regular distribution. Girls would find it harder to get an over-the-counter product if a single
package costs were not within their price range. It would also be harder for women to take too many pills
or overdoes, if the Plan B drug is sold in single packages. However, the prescription product should not
be as expensive as the over-the-counter product and it does not have to be sold in single packages. If
women are prescribed the emergency contraceptive from a licensed doctor or practitioner then they
should not go through the hassle that those who buy the over-the-counter product have to go through.
<8: 2.1>Lester M. Crawford, the FDA Commissioner, has to make a major decision of whether or not to
initiate rulemaking for the emergency contraceptive. He may have to weigh the political aspects but that
should not be his major focus, instead he should focus more on the scientific and clinical evidence. If the
Plan B, emergency contraceptive, really does cause more harm than help, then of course the drug should
stay as a prescription, but if the drug does not show any proven evidence of harming those who consume
the pill, then he should initiate rulemaking. He may however, have to take precautionary steps in the
process by limiting sale of the over-the-counter product to a certain age group and selling the drug in
single packages.
COMMENT NUMBER - 2005N-0345-EC14491
2005N-0345-EC14491 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Corlette, Chauncey
2005N-0345-EC14491 - TEXT
GENERAL
See Attachment
2005N-0345-EC14491-Attach-39.DOC
ATTACHMENT:
<1: 2.2>The process of proposed rulemaking and allowing the public to provide their input on key factors
of today's important regulatory and policy questions and is a great privilege to have here in America. The
trends of the nation are constantly changing and with the constant growth in the fields of medicine,
technology, agriculture and so many more. There is a new burden placed on governmental agencies to
make rules that apply to this growing nation. There are several questions that have been raised
during the subject of allowing the plan B pill to the over the counter market, those questions were;
1) Can age be used as a criterion on which we decide whether a drug should be prescription or over-the-
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counter, as has been proposed in this case?
2) Can the prescription and over-the-counter version of the same drug be marketed in a single package?
3) In addition, if we do use age as the only criterion on which we decide whether a drug is sold as a
prescription product, or an over-the-counter product, how, as a practical matter, would such a limitation
be enforced?
4) In the Plan B application, we are grappling not with the same question but with a different question:
whether we can have the same molecule exist as both a prescription and over-the-counter product for the
SAME indication?
5)And if FDA were to attempt to limit sale of an over-the-counter product to a particular sub population,
would FDA be able to enforce such a limitation as matter of law, and could it do so as practical matter
and then how?
This paper will answer the listed questions, but not in the listed order.
The question was posed Question #2) Can the prescription and over-the-counter version of the same drug
be marketed in a single package? <2: 8.1, 8.3.1>The prescription and the over-the-counter version of the
same drug can be used and marketed in the same package only if the product is labeled properly. The
FDA has very rigid rules for labeling for over-the counter drugs. The prescription and the over-the-
counter version would need to adhere to the rigid rules of labeling; Drug Facts, Active ingredient,
Purpose, Use(s), Warning, Do not use , Ask a doctor before use if you have, Ask a doctor or pharmacist
before use if you are ,When using this product, Stop use and ask a doctor if ,Pregnancy/breast-feeding
warning, Keep out of reach of children/Accidental overdose warnings, Direction , Other information,
Inactive ingredients, and Question(Optional) and also have a statement on the package addressing the fact
that the drug's intended use is safe for women 17 years of age and older without a prescription and for
younger females they would require a licensed physician to write a prescription for the drug.
The question of having the same packaging for a drug leads to Question # 4) whether we can have the
same molecule exist as both a prescription and over-the-counter product for the SAME indication? <3:
3.9.1, 6.3.4>Currently the FDA allows the same molecule to be sold as a prescription product and an
over-the-counter product, but there is a meaningful difference in the way the two products are used.
Understanding that and the previous precedent was if a drug was unsafe for any public it would be
classified as a prescription drug. The precedent would have to change, to serve the majority of the
population it is purposed for, the majority of women would be able to benefit from this drug and be
unsafe for a small sub-population. The drug will have a meaningful difference in being safe and
appropriate for women 17 years of age and older. This Plan B drug is relatively safe for the majority of
the public which is women 17 years of age and older the sub-population of minors until the age of 16
would be the only ones that the drug use would be inappropriate for without the consent of a doctor.
Since age is a major issue with the use of the plan B drug it relates to Question # 1) <4: 6.3.4, 6.6.3>Can
age be used as a criterion on which we decide whether a drug should be prescription or over-the-counter,
as has been proposed in this case? Yes, there is already a precedent of the government regulating items
based on age regarding alcohol and cigarettes. In today's markets there are controlled substances and
items that have regulations based on age. The examples of which are alcohol and cigarettes both have had
age limits set by the federal government. Alcohol and cigarettes, both are products that are sold publicly
with only burden to prove, which is age. The reason of doing so is that some items take a certain maturity
that hopefully comes with age to govern whether one should use the item and the amount of the item that
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one should use.
The following questions ask how the age limit would be enforced in practical ways. Question # 3) In
addition, if we do use age as the only criterion on which we decide whether a drug is sold as a
prescription product, or an over-the-counter product, how, as a practical matter, would such a limitation
be enforced? And Question # 5)And if FDA were to attempt to limit sale of an over-the-counter product
to a particular sub population, would FDA be able to enforce such a limitation as matter of law, and could
it do so as practical matter and then how?<5: 3.8.2, 7.4.1> Ways to enforce the limitation of age would to
sell the drug behind the counter. The creation of behind the counter option in the United States would
alleviate safety concerns between the availability of over the counter drugs to the public without any kind
of professional conciliator. Pharmacists would be able not only limit the amount of drugs and keep track
of buyers but also to provide counseling prior to administering the drug. The matter of law is making it
mandatory for the drug to be sold behind the counter, having the pharmacist describe the drug and its side
effects, having the persons who purchase the drug to agree to sign for it and present identification with
their age on it. This would enforce the regulations for being able to sell the drug. There is a growing need
for behind the counter drugs. For example; There has already been a push to have drugs that contain
pseudoephedrine (ex. Sudafed), as their active ingredient, behind the counter because they are used to
make crystal methamphetamine, an illegal drug. Having behind the counter drugs would allow effective
medications that are relatively safe to be used in proper ways and available to the public.
<6: 1.1>In a changing and growing society with a new self- care movement becoming more and more
popular, the FDA is faced with a challenge to set new precedents to serve the majority of people instead
of small sub-populations also to incorporate measures of safety by introducing new safe guards like
behind the counter drugs. The changes would not only effect the decision of allowing the plan B drug to
be introduced to the over-the counter market but many other drugs to maintain the health of United States
citizens and allow drugs that are safe and effective to serve their purpose.
COMMENT NUMBER - 2005N-0345-EC14598
2005N-0345-EC14598 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Garden, Nicole
2005N-0345-EC14598 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.1, 3.3.3>Part of the reason the birth control pill is marketed as a prescription and not an over-the-
counter product is because of the many dosages, forms, and active ingredients it comes available in,
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which require dosing by a medical professional such as a physician, and monitoring to ensure
effectiveness.
Because the emergency contraceptive is a standardized one-time dose, these factors do not come into
play.
GENERAL
GENERAL
<2: 1.2.1>Many of the reasons surrounding blocking the much-lauded Emergency Contraceptive Pill are
related to Right-To-Life movements and the anti- choice agenda. These individuals in groups attempt to
restrict the personal freedoms of women using proven, safe, effective birth control methods such as the
Pill and Plan B, in the hopes of producing an unwanted pregnancy. Morally, these groups claim to be 'pro-
life', but a lack of availability of these products (and the incredible cost to the state and otherwise of
surgical abortions that must then be performed, which many low-income women cannot afford, when they
could have afforded Plan B over the counter,) results in a high birth rate among impoverished women,
further increasing loads on the social safety net, further impoverishing these communities as a whole, and
guaranteeing an all-around poor quality of life for these children and their mothers. Approving Plan B for
use over the counter would help drive down the astonishing abortion rate. Even the anti-choice movement
cannot argue with a dropping abortion rate.
COMMENT NUMBER - 2005N-0345-EC146
2005N-0345-EC146 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Steele, Robert
2005N-0345-EC146 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.3.3>If 503(b) does not allow for the simultaneous marketing of a drug based on age or other
factors, it should be amended. Precedences exist for such substances such as alcohol and tobacco products
to be marketed based on age. The purchase of other non-ingestible items are certainly marketed by age,
mental competency, criminal convictions, etc.. This is not a difficult and/or complexed procedure.
1.
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.1>This too is not a difficult or complexed task. If an amendmentis - based on changing
circumstances warrants - obvious and needed, than the change(s) should made based on procedural issues
and not politics or ideological leanings.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I do not have sufficient insight to warrant commenting on this issue.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1, 5.5>Certainly greater clarification and less ambiguity is always a plus. 503(b) does not have to be
fit for all issues, amendments - with future consolidation - are appropriate.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2, 6.5.1>"Enforcement" should not be the FDA's primary responsibilty in these cases - rulemaking
is. <5: 7.3.1.4, 7.4.1>Rules governing the OTC and precription sale of certain drugs are
guidelines for the distributors and retailers, it is they who must determine how this will occur. If they fail,
the FDA has grounds for action, possibly to cease distribution until remedial action is taken to resolve the
problem. However, I doubt that this would be necessary since manufacturers benefit a lot more from sales
than from a loss of their ability to sell. OTC and prescription drugs can be simultaneously sold from
behind the counter to eligible customers. <6: 6.2, 6.5.1>At issue is whether the eligible
customer distributes the drug to his or her child - as long as the drug is deemed safe - this is outside of the
realm of FDA jurisdiction.
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 7.1, 7.4.1>Very simply. By distribution of the drug from the pharmacist's store room, after he or she
has determined that the buyer is eligible to make the purchase. This is already in effect for many products
being sold in our pharmacies.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 6.6.3, 8.1>Of course they can. The customer is buying an OTC product which has a buyer's
stipulation. Think tobacco products and alcohol. If a doctor prescribes the use of the drug (which is
commonly OTC for a certain age group and above)than handing the customer the same product in the
same package (accompanied by the pharmacist's normal instructions and packing) is not a mind bending
issue.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
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inappropriate to do so?
<9: 9.1.1>It would be inappropriate if the sale was made to an ineligible customer or an ineligible (say
with age restrictions) customer who does not have a valid doctor's prescription. If it were possible for a
person of authority to "prescribe/authorize" the sale of cigarettes to a minor, simply the seller would hand
them the Marlboro of their choice.
GENERAL
GENERAL
<10: 1.2.1, 2.1>I'm responding to these questions as a result of recent FDA decisions regarding Plan B.
The issue here really isn't how do we make sales to authorized buyers only... there are simple and obvious
answers to this procedural question... the issue really feels like personal ideologies and/or political-
ideology. The scientific and health related facts seem to be in - the conclusions (at this point in time)are
that Plan B post-intercourse anti-conceptional drugs are safe. The FDA's unbiased ruling(s) should track
with the scientific evidence unless otherwise refuted by competent counter-conclusions. Birth control is a
personal decision only. As much as certain fundamentalist groups would like to dictate their beliefs on to
others, that is unacceptable, as sure as I am that rules made contrary to their beliefs would be
unacceptable to them. The FDA needs to follow the guidances provided by their doctors and researchers
and shy away from ideological pressures coming from any direction.
COMMENT NUMBER - 2005N-0345-EC147
2005N-0345-EC147 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Loomis, Shirley
2005N-0345-EC147 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes, provided the drug is safe for distribution. <2: 1.2.1>Items such as Plan B have an
impact on "quality of life," and if someone under 16 is seeking it, they are either already a child at risk for
whom life is very challenging, or for some reason they are not in a position of being able to seek the
assistance of their parents. As a parent, I want my children to always be able to come to me but more
importantly I want them to be able to get what they need in a crisis through whatever means in
available.
1.
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
See above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1>There's significant confusion regarding all regulations. It's what keeps your lawyers working.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.2>No. You will not dispel confusion. You may just simply be better able to serve the American
public.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.2, 6.7, 7.5.3>No you would not necessarily be able to enforce it but there are many unenforceable
laws. You would however be putting forth a best efforts practice.
B. If it could, would it be able to do so as practical matter and, if so, how?
See above.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2, 8.6.2>They should be packaged differently to help alleviate confusion for those responsible for
handling them.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
See above.
GENERAL
GENERAL
See above.
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COMMENT NUMBER - 2005N-0345-EC148
2005N-0345-EC148 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Scott, Cindy
2005N-0345-EC148 - TEXT
Issue Areas/Comments
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
THIS SEEMS LIKE BS TO ME. <1: 3.9.1, 8.1, 8.8>I ALREADY RECEIVE CLARITIN
(LORATADINE) 10 MG BOTH VIA PRESCRIPTION OR I CAN BUY IT OVER THE COUNTER. I
DON'T THINK THERE IS A PROBLEM WITH SELLING THE PRODUCT IN THE SAME
PACKAGE.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<2: 9.2.2>NONE
GENERAL
GENERAL
<3: 1.2.1, 2.1>I find it to be an extreme disservice to women and shame on the FDA that the Plan B pill is
not available over the counter. Women - particularly adult women in the United States should have had
access to this a long time ago. Please STOP ALL THIS BEAURACRATIC BS AND approve this
reproductive health care option ASAP.
sincerely,
Cindy Scott
COMMENT NUMBER - 2005N-0345-EC15
2005N-0345-EC15 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Marshall, Laura
2005N-0345-EC15 - TEXT
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Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.1>Codifying an interpretation can only help--make it clear exactly why and when a drug is
being marketed OTC and Rx at the same time, and make it clear that the reasons are not political but
medical. <2: 3.9.1>Ibuprofen, ranitidine and other histamine receptor agonists, many
drugs are currently sold OTC and prescription, but the issue there is about dosage, not a moral
determination.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1>I would say so; confusion and rumor, not to mention bad PR for the FDA.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.1, 5.3.2>Yes. Make it clear what the determiners are of such decisions; that will make it easier on
the FDA and clearly more of an issue of fact than politics.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 7.2, 7.5.3>As a matter of law, perhaps, but fake IDs and passing on of a prescription legally
purchased would make the reality different. <6: 6.5.4>And the likelihood is that making it
harder to get for a specific subpopulation would engender lawsuits, more court cases, and further
confusion as non-medical angencies and entities enter into the process.
B. If it could, would it be able to do so as practical matter and, if so, how?
See Above.
GENERAL
GENERAL
<7: 1.2, 2.1>Please try to keep politics out of the drug-approval decision-making process. I don't know
the FDA charter, or the regulations binding its decision, but my guess is that nowhere in those documents
is there any requirement that so-called moral factors be taken into account. There are moral arguments on
both sides of this issue, and the best middle ground is factual and scientific when the matter is, itself, a
factual and scientific matter. Is the drug safe for the population it will be sold to? Is it effective? Is it,
perhaps, already available off-label? Those are the questions the FDA should answer, not whether it's
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either moral to sell or politically expedient.
COMMENT NUMBER - 2005N-0345-EC155
2005N-0345-EC155 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Lamotte, Diane
2005N-0345-EC155 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes, I believe a rulemaking is in order. <2: 3.9.1>It doesn't seem too different from a
medication being OTC in one case and not being OTC when combined with something else - especially
when that something else is also OTC. Note Guaifenesin - long acting vs short, with or without a
decongestant. Patients ask us why these items are prescription but can be bought separately OTC when
combined.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.3.2, 7.1>I believe that health professionals and consumers expect the FDA to make a decision. Also
they expect that the FDA can make any decision - and we will of course comply, whatever it is - even if it
is novel.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.1>Yes, just give us the rulemakeing.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.1>I believe that the FDA can enforce whatever it wants or needs to. <6: 6.6.1>Pharmacies
currently comply with a multitude of regulations and policies. I manage a small pharmacy at a student
health clinic and have no space for OTC self selection (or payment). Therefore, as a matter of policy, we
pharmacists put OTC's into our Rx computer system and house them inside our pharmacy - so that the
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patient has to request the OTC item. We have personalized records on everyone regarding Rx and OTC
medications. This is great for medication review and counseling. Additionally, I have practiced pharmacy
in 3 different states. The pharmacists comply with both federal and state regs. The state regs change from
state to state and we keep the records as required - logs for needles and syringes - C-V cough medicines
can be signed out in some states - whatever the ruling, we'll comply.
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 3.8.2, 7.4.1>I visited Ontario, Canada and saw that they had a form to fill out and keep regarding EC.
Of course, Canada already has that third class of "OTC, but limited and behind the counter", where
patients must request the medication. We have a similar system in California, where pharmacists can
prescribe and dispense EC. This works very well - if you have enough counseling space in your
pharmacy. <8: 7.1>Whatever you decide will be what is complied with. <9:
7.4.4>How about checking ID like for alcohol purchasing, <10: 7.4.6>or accepting implied
truth of asking for the patient's birthday and believing them. <11: 7.5.3>Obvoiusly, if patients
over 16 years of age can get it OTC, then it will be easy to acquire and anyone old enough can get it and
give it to whomever they choose.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<12: 8.1>I think it is perfectly fine to use the same packaging. The patient will benefit from the best
packaging whether they are 15 or 35. <13: 8.8>Also, the packaging is the same for C-V cough
medicines that are prescription in some states but behind the counter in other states, where patients sign a
special book.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<14: 9.2.2>Don't know of any...
GENERAL
GENERAL
<15: 1.2.1>It seems to me like the United States is behind the eight ball on this one. Many other
developed countries have EC OTC - there is precidence elsewhere - we are not re-inventing the wheel
here. I know that women have sex (what a surprise!) and either have a problem with their contraception
or, the couple didn't plan ahead. The woman should not be the only responsible party here - it takes two to
tango. I help women every day avoid abortion, by providing contraception and EC. I would think that
every health care provider would want to join me! I am sure you are aware of the JAMA article about
access to EC that points out that promiscuity is not increased by the availability of EC. And abortion rates
have been reduced since EC has been available. Our pregnancy numbers have reduced here at UC Santa
Cruz when we began providing EC through the pharmacy. You can't argue with success! Thank you for the opportunity to comment.
COMMENT NUMBER - 2005N-0345-EC1565
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2005N-0345-EC1565 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Yao, Yvonne
2005N-0345-EC1565 - TEXT
Issue Areas/Comments
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 1.2.1>Although I believe that OTC access to all age groups would benefit the individual as well as
society, <2: 6.1, 6.6.3>I also see that age limited access is used in the sale of other products
e.g. tobacco and alcohol. Therefore it seems that regulation by law would be possible as it has for these
other products.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.1, 7.4.1, 7.4.4>It could be handled like alcohol and tobacco, but perhaps by the pharmacist instead
of the general retail clerk. For patients 18 or older, a picture id would allow purchase; for patients under
18, a prescription would be required. (Those without photo id might prefer to get a prescription from their
doctors.)
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.1, 8.4.1>As long as the product is the same, it seems more "truthful" to package it in the same
manner. It avoids the impression that one product is better or stronger.
GENERAL
GENERAL
<5: 1.2.1>Although it is possible to sell this product differentially to different types of patients, given that
the product is safe and effective in younger as well older women, it would be preferable to sell it to all
women over the counter to reduce barriers to access. Younger woman are perhaps more likely to require
confidentiality and also are more likely to be intimidated by the need to speak to a person of authority.
COMMENT NUMBER - 2005N-0345-EC15687
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2005N-0345-EC15687 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Academy of Managed Care Pharmacy
2005N-0345-EC15687 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
The FDA has interpreted the language in section 503(b) of the Durham-Humphrey Amendments to allow
marketing of the same active ingredient in products that are both prescription and OTC, assuming some
meaningful difference exists between the two that makes the prescription product safe only under the
supervision of a licensed practitioner. The key distinction in all current examples of products sold both
OTC and by prescription is that there is some meaningful difference between the two products (e.g.,
indication, strength, route of administration, dosage forms). To date, the FDA has not allowed marketing
of the same active ingredient in a prescription product for one population and in an OTC product for a
subpopulation. However, the FDA has acknowledged that its interpretation of section 503(b) of the act
has not been explicitly set forth in any of the regulations that discuss the process by which FDA classifies
drugs as OTC or prescription.
AMCP does not believe that the FDA has the authority to allow marketing of the same product as both a
prescription drug and OTC product. For a medication to be granted OTC status, it must have a wide safety
margin, be effective, and bear labeling understandable to ensure proper use. The FDA must determine that
the labeling provides enough information for safe use by the general public. If the FDA determines that a
drug meets the above conditions to be granted OTC status, then the drug is considered safe enough to be
sold without a prescription.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
One question posed by the FDA in the Federal Register is whether, assuming that it is legal to market the
same active ingredient in both a prescription and OTC product, the different products may be legally sold
using the same packaging. The Academy believes that the two products must be sold in different
packaging. On May 16, 2002, OTC drug manufacturers were required to begin using the new
standardized label for OTC medicines. The following information must appear on the OTC label:
? The product?s active ingredients, including the amount in each dosage unit.
? The purpose of the medication.
? The uses (indications) for the drug.
? Specific warnings, including when the product should not be used under any circumstances, and when it
is appropriate to consult with a doctor or pharmacist. The warnings section also describes side effects that
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could occur and substances or activities to avoid.
? Dosage instructions addressing when, how, and how often to take the medication.
? The product?s inactive ingredients, which is important information for those with specific allergies.
The FDA requires that this information be in a certain format with standardized headings and subheadings
and requires that the information be presented with certain graphical features.
The FDA also has specific labeling requirements for prescription medications. A prescription drug
product is deemed to be misbranded if, at any time prior to dispensing, its label fails to bear the statement
?Rx only? or ?Caution: Federal law prohibits dispensing without prescription.?
AMCP also recommends that the Rx and OTC products need to have two distinct National Drug Code
(NDC) numbers. The NDC number is the commonly accepted code for identifying packages of drugs. It is
a unique number that identifies the drug, strength and packaging and is the HIPAA-required identifier for
drug product claims. To allow managed care organizations, other third-party payors and drug information
database providers to properly differentiate the prescription and OTC products for claims adjudication,
the product must have a distinct NDC number.
2005N-0345-EC15687-Attach-48.DOC
2005N-0345-EC15687-Attach-48.DOC
ATTACHMENT:
October 31, 2005
Documents Management Branch
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket 2005N-0345
The Academy of Managed Care Pharmacy (AMCP) is pleased to provide comments to the Food and Drug
Administration (FDA) on circumstances under which an active ingredient may be simultaneously
marketed in both a prescription drug product and an over-the-counter (OTC) drug product.
The Academy of Managed Care Pharmacy (AMCP) is a national professional association of pharmacists
and other health care practitioners who serve society by the application of sound medication management
principles and strategies to achieve positive patient outcomes. The Academy's 4,800 members develop
and provide a diversified range of clinical, educational and business management services and strategies
on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit.
<1: 3.3.2, 3.9.1>The FDA has interpreted the language in section 503(b) of the Durham-Humphrey
Amendments to allow marketing of the same active ingredient in products that are both prescription and
OTC, assuming some meaningful difference exists between the two that makes the prescription product
safe only under the supervision of a licensed practitioner. The key distinction in all current examples of
products sold both OTC and by prescription is that there is some meaningful difference between the two
products (e.g., indication, strength, route of administration, dosage forms). To date, the FDA has not
allowed marketing of the same active ingredient in a prescription product for one population and in an
OTC product for a subpopulation. However, the FDA has acknowledged that its interpretation of section
503(b) of the act has not been explicitly set forth in any of the regulations that discuss the process by
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which FDA classifies drugs as OTC or prescription.
<2: 3.3.2, 6.2>AMCP does not believe that the FDA has the authority to allow marketing of the same
product as both a prescription drug and OTC product. <3: 3.3.2, 6.5.1>For a medication
to be granted OTC status, it must have a wide safety margin, be effective, and bear labeling
understandable to ensure proper use. The FDA must determine that the labeling provides enough
information for safe use by the general public. If the FDA determines that a drug meets the above
conditions to be granted OTC status, then the drug is considered safe enough to be sold without a
prescription.
One question posed by the FDA in the Federal Register is whether, assuming that it is legal to market the
same active ingredient in both a prescription and OTC product, the different products may be legally sold
using the same packaging. <4: 8.2>The Academy believes that the two products must be sold in different
packaging. <5: 8.5.1>On May 16, 2002, OTC drug manufacturers were required to begin using
the new standardized label for OTC medicines. The following information must appear on the OTC
label:
The product's active ingredients, including the amount in each dosage unit.
The purpose of the medication.
The uses (indications) for the drug.
Specific warnings, including when the product should not be used under any circumstances, and when it
is appropriate to consult with a doctor or pharmacist. The warnings section also describes side effects that
could occur and substances or activities to avoid.
Dosage instructions addressing when, how, and how often to take the medication.
The product's inactive ingredients, which is important information for those with specific allergies.
The FDA requires that this information be in a certain format with standardized headings and subheadings
and requires that the information be presented with certain graphical features.
The FDA also has specific labeling requirements for prescription medications. A prescription drug
product is deemed to be misbranded if, at any time prior to dispensing, its label fails to bear the statement
"Rx only" or "Caution: Federal law prohibits dispensing without prescription."
<6: 8.5.3>AMCP also recommends that the Rx and OTC products need to have two distinct National
Drug Code (NDC) numbers. The NDC number is the commonly accepted code for identifying packages
of drugs. It is a unique number that identifies the drug, strength and packaging and is the HIPAA-
required identifier for drug product claims. To allow managed care organizations, other third-party
payors and drug information database providers to properly differentiate the prescription and OTC
products for claims adjudication, the product must have a distinct NDC number.
Therefore, although the Academy believes that an identical medication should not be approved in both a
prescription and OTC form, if such a decision is made, the Academy believes the prescription and an
OTC medication must be sold in different packaging in order to be in compliance with existing
regulations and to allow proper claims adjudication.
AMCP appreciates the opportunity to comment on this extremely important issue. If you have any
questions, please contact Judith A. Cahill, AMCP Executive Director, at (703) 683-8416 or at
jcahill@amcp.org.
Sincerely,
Judith A. Cahill
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Executive Director
COMMENT NUMBER - 2005N-0345-EC15690
2005N-0345-EC15690 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Association of American Physicians & Surgeons
2005N-0345-EC15690 - TEXT
GENERAL
See Attachment
2005N-0345-EC15690-Attach-49.TXT
ATTACHMENT:
Comments re: Docket No. 2005N-0345, RIN 0910-AF72
Drug Approvals: Circumstances Under Which an Active Ingredient May be Simultaneously Marketed in
Both a Prescription Drug Product and an Over-the-Counter Drug Product.
The Association of American Physicians & Surgeons (AAPS) is a nonprofit national group of thousands
of physicians. Founded in 1943, we are entirely member-supported and do not accept funding from
industry. Courts and medical boards frequently welcome our amicus curiae briefs and letters. Justices of
the United States Supreme Court have cited materials we submitted, see Stenberg v. Carhart, 530 U.S.
914 (2000); the Privacy Rule also cited us, see 65 F.R. 82462, 82468 (Dec. 28, 2000). We have
successfully sued the Food and Drug Administration (FDA) for exceeding its authority in the past. See
Ass'n of Am. Physicians & Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002).
<1: 3.1, 3.4>The FDA should not render a decision affecting millions of Americans without allowing full
notice and comment by physicians and patients, pursuant to a formal rulemaking proceeding. The
Administrative Procedures Act (APA) requires notice and comment prior to promulgation of a new rule,
and there is no valid reason to deny public input on the important issue of marketing an active ingredient
as both a prescription drug and over-the-counter (OTC) drug. AAPS objects to any attempt by the FDA
to bypass notice and comment procedures in connection with Section 503(b) of the Federal Food, Drug,
and Cosmetic Act (FDCA), as modified by the Durham-Humphrey Amendments, which governs the
classification of drugs.
<2: 6.5.1>AAPS further observes that the FDA lacks statutory authority to approve a drug for OTC
purposes for one age group while retaining prescription requirements for the same drug for another age
group. If the FDA feels it has such authority, then it needs to promulgate its position in a formal
rulemaking procedure, including notice and comment by physicians. For the following reasons, AAPS
submits that the FDA lacks such authority to classify the same drug as OTC for one age group but
prescription use for another.
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<3: 6.5.1, 6.6.1, 6.6.2>Once the FDA has determined that a drug requires a prescription, then by
definition that drug has a potential for harmful effect. That potential for harm does not change based on
whether the recipient is 15 years old, 16 years old, 17 years old or 18 years old. Congress and state
legislatures have the sole power to draw distinctions between those ages for the consumption of food or
drugs. The FDA does not.
<4: 6.5.2, 6.6.1>An age-based classification for prescriptions would constitute an intrusion by the FDA
into an area of traditional state regulation: parental notification or consent for the medical treatment of
minors. If the FDA were to decide that a drug requires a prescription for a 15-year-old but not for a 17-
year-old, then such decision would transfer power over issues of consent by minors to the FDA from the
states. Nothing in Section 503(b) or elsewhere gives the FDA such authority to decide at what age a
minor is mature enough to buy OTC drugs that have life-changing effects.
<5: 6.6.1, 7.5.2>The possibility that a state could regulate the age at which a minor could purchase an
OTC drug does not satisfy our objection. States have regulatory schemes that are not designed for, or
equipped to, deal with the illegal distribution of OTC drugs to minors. In the case of reproductive
activity, adult men are often responsible for victimizing and impregnating much younger girls. The adult
men could and often would circumvent any age requirement on the purchase of the OTC drugs by
underage girls. The FDA should not propose an age requirement for OTC drugs unless it has adequate
means and resources to enforce it. It does not.
<6: 1.2.3, 7.5.3>Our concerns are heightened in the context of teenagers confronting sexual reproduction.
They often lack the maturity and financial independence of adults to make informed decisions about their
health and well-being. Teenagers are highly susceptible to peer pressure and misinformation denying
possible long-term adverse effects of interference with a pregnancy. It is wholly unrealistic to suggest, as
some have, that a "morning after pill" made available on an OTC basis to 16 or 18 year-olds will not be
widely distributed to younger girls. As an organization of physicians who must deal with subsequent
medical harm, AAPS objects to an age-based classification allowing OTC sales of a morning after
pill.
<7: 6.6.1>AAPS reminds the FDA that the states require parental consent for most medical decisions
made by minors. California, for example, just reenacted its requirement of parental consent for body-
piercing of a minor. See 2005 CA A.B. 646 (signed by the governor of California on Sept. 22, 2005).
The vast majority of states require parental notification or even consent prior to performing an abortion on
a minor. Making a drug available on an OTC basis renders parental consent impossible. When a
prescription is required for the drug, a trained physician can assess the benefits and harms, and advise a
minor and her parent appropriately. When the drug is sold over the counter, there is no professional
evaluation or meaningful way for a minor to learn and evaluate the medical harm.
<8: 10>AAPS emphasizes that childbirth confers undeniable health benefits on the mother, and
interruption of a pregnancy is indisputably harmful compared to childbirth. The FDA should not render
any decision concerning increased availability of a drug to interfere with pregnancy without hearing from
all sides of the medical community about the harm of preventing childbirth. The medical literature
contains many peer-reviewed studies demonstrating how harmful pregnancy termination is to one's
health. See generally J.M. Thorp, Jr., K.E. Hartmann, and E.M. Shadigian, "Long-Term Physical &
Psychological Health Consequences of Induced Abortion: Review of the Evidence," 58 OB/GYN Survey
1, at 67-79 (2003); D.C. Reardon, P.G. Ney, F.J. Scheuren, J.R. Cougle, P.K. Coleman, T. Strahan,
"Deaths associated with pregnancy outcome: a record linkage study of low income women," 95 Southern
Medical Journal 8, at 834-41 (August 2002) ("Higher death rates associated with abortion persist over
time and across socioeconomic boundaries."); Karen Malec, "The Abortion-Breast Cancer Link: How
Politics Trumped Science and Informed Consent," 8 J. Am. Physicians & Surgeons 41 (Summer 2003)
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(the vast majority of studies have found that abortion increases the risk of breast cancer),
http://www.jpands.org/vol8no2/malec.pdf (viewed Aug. 3, 2005). A morning after pill can be expected to
cause harm and the FDA should not facilitate bypass of informed consent in consultation with a
physician. Mixing OTC and prescription classifications for the same drug would thwart informed consent
and lead to unanticipated harm to patients.
<9: 3.1, 3.4>In sum, AAPS objects to any assertion in authority by the FDA to make age-based
classifications for prescription and OTC sales of drugs. If the FDA is seeking such authority, then at a
minimum it needs to comply with formal rulemaking and address the objections raised by physicians and
patients alike.
COMMENT NUMBER - 2005N-0345-EC157
2005N-0345-EC157 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Smith, Jennifer
2005N-0345-EC157 - TEXT
GENERAL
<1: 1.2.3, 3.8.8>If this product contains one of the same active ingredients used in ordinary prescription
birth control pills -- only in the case of Plan B ? each pill contains a much higher dose and is taken in a
different way. Then, why is it being considered for OTC when other birth control pills require a
perscription? Whouldn't some women use this OTC as birth control rather than visit their physician for a
perscription and checkup?
COMMENT NUMBER - 2005N-0345-EC15931
2005N-0345-EC15931 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Walsh, Melissa
2005N-0345-EC15931 - TEXT
Issue Areas/Comments
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
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<1: 3.8.4>A. The FDA's current interpretation of section 503 (b) is a common sense definition of the law.
Although it is unnecessary, the FDA could codify its current policy and reasoning for how it decides
whether a product with the same active ingredient is distinguished from OTC and prescription (i.e. A
product with the same active ingredient is available OTC in low concentrations because it is safe at weak
concentrations, while the same product is made prescription based on the greater concentration or more
potent method of dispersal). Since the FDA's policy on the law has served our country well for about 20
years, there should be no doubt to the validity of its interpretation.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 3.1, 3.3.2, 4.2, 4.4.1>B. The FDA's interpretation is an accurate interpretation of the law. It is also
scientific, because this policy is in keeping with the known fact of chemistry that to decrease the toxicity
of a product its concentration must be in some way decreased. Thus it must follow in medicine, if a drug
is to be safe it must be marketed at non-injurious levels. If it is sold at higher concentrations it should be
under the supervision of a physician. Consequently there should be no confusion to the FDA's policy as it
is both scientific and in keeping with the intent of the law. In order to avoid future challenges by drug
companies and pharmacies to the FDA's interpretation of 503(b) of the act, the FDA's unwritten
interpretation should be codified as law.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.2, 6.5.4>A. If the FDA limited the sale of an OTC product by making it remain prescription for a
subpopulation what would be its reasoning? If a product is made over the counter, and yet is unsafe for
certain individuals, the FDA's integrity could be held in question. The FDA could be accused of
discrimination against that subpopulation or approving a dangerous drug to please drug companies. Either
way the general public would receive mixed messages which may cause them to doubt the trust they put
in the FDA. <4: 7.5.3>Also, if the FDA did put such questionable policies into practice,
would be unable to ensure that the drug did not fall into the hands of the subpopulation they are trying to
protect. Illegal activities could take place, for example the problem with underage intake of alcoholic
beverages; it is illegal yet the drug falls into the hands of minors. The only way the FDA could insure a
dangerous drug does not fall in the wrong hands is through a prescription basis.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2, 7.5.2>B. If the FDA made an OTC product illegal for an underage population. It would not be
practical because a possible dangerous drug would be used with less caution by the public because it is
readily accessible. A product, with possible dangerous side affects, under a physician's guidance are more
quickly detected and treated. If such a drug is readily available the FDA would need to educate and
protect the public in the same way as a physician. This would be an unnecessary role for the FDA to take
on.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
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<6: 9.1.1, 9.2.2>A. In the FDA's current policy it has established the precedent that if the same product is
sold as prescription and OTC the difference would need to be the concentration or method of dispersal. If
the FDA were to sell different products legally under the same package it would have to ensure that the
following conditions were met: I. The product has no harmful or damaging effects on the patient. II.
Prescription only for the sub-population that may be harmed by the drug, for example if drug is only
dangerous to the person who is a minor or has allergies or diabetes. III. The FDA would need to ensure
that the OTC product did not fall into the hands of minors which must gain access to the drug by
prescription basis. They must to be able to prove the agency's effectiveness to overcome the common
problem of illegal drugs such as steroids falling into the wrong hands. The FDA would need the necessary
strength to overcome this negative precedent which it has not been able to do in the past. IV. The
regulation is not made to discriminate based on age, race, or ethnic background. Since the product should
be safe for the general population, if the same product is marketed as OTC and prescription in the same
package.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.1>B. It would be inappropriate to lawfully sell under the same package an OTC product that could
permanently change normal bodily functions. For example steroids and other drugs which alter the
hormones to treat a disease or remove unwanted symptoms of growth or illness. If the FDA made these
products readily available without distinguishing, as it has in the past, the danger of a product under
different concentrations, the public would be done great damage and disservice by the FDA's change of
policy.
COMMENT NUMBER - 2005N-0345-EC16
2005N-0345-EC16 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Smart, Stephanie
2005N-0345-EC16 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.3.3>A drug is not only its active ingrediant. It is a combination and has different uses based on
the combination or the dosage. So yes, I think that a drug should be available by prescription and OTC
containing the same active ingrediant.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 170 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 162
drug product?
Same answer as above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No, but I do not agree with the interpretation.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.5.4>I think this is a poor policy consideration. By limiting drug availabilty you open the door for
discrtimiation based on race, age, gender, and socioeconomic status. The drug should be available to
anyone who would have a usage for it based upon the labeling.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.9>How could they be in the same package if they have different uses? Why would you have exactly
the same product available by prescription and OTC? If an active ingrediant is available OTC and by
prescription then wouldn't they automatically have different packaging becasue they would have different
uses>
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<5: 8.9>What two products? This is not clear. If you are referreing to the above question it doesn't make
sense. They wouldn't be in the ame package if one is by prescription and one is OTC.
GENERAL
GENERAL
Please approve Plan B for OTC with no limitations on purchase. This is not Birth control. This is for
emergencies and allows women a recorse when accidents occur such as a condom breaking. By allowing
the sale of this product as an OTC item then you allow access to all socioeconimc classes of women.
COMMENT NUMBER - 2005N-0345-EC160
2005N-0345-EC160 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Bachelor, Emiliann
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 163
2005N-0345-EC160 - TEXT
Issue Areas/Comments
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 6.1>Yes.
B. If it could, would it be able to do so as practical matter and, if so, how?
<2: 7.1>Yes. <3: 6.6.3>Akin to alcohol and tobacco, Plan B can be regulated. <4:
6.6.3, 7.4.6>This does not suggest a comparison of products, but a comparison of distribution methods.
Pharmacies and drug stores can place notices, as with tobacco and alcohol, that no one under the age of
17 will be allowed to purchase Plan B over-the-counter. <5: 7.4.4>Pharmacists and store
cashiers should be allowed to require photo identification in order to purchase Plan B over-the- counter
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2>No. <7: 8.6.4, 9.1.2>That would cause undue confusion at the store level. Prescription
drugs and their over-the-counter equivalents should always be packaged differently.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.1.1>If the two products were actually different products, then it would be very inappropriate to sell
them in the same packaging. However, this is not the case here. <9: 8.2, 8.7>This is a
difference of classification. The product itself is the same. Other medications utilize different packaging
for over-the- counter and prescription equivalents. These different classifications of Plan B should be
packaged differently.
GENERAL
GENERAL
<10: 1.2, 2.1>I implore your panel to not allow politics to interfere with science. Uninsured women need
access to medications like these. If women cannot afford health insurance to provide prescription drugs to
protect their reproductive rights, then is it very likely that the children raised in such environments will
face the consequences of being poor in the United States. Women and children are the poorest
demographics in the world, including the United States. Help them.
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COMMENT NUMBER - 2005N-0345-EC162
2005N-0345-EC162 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hutson, Paul
2005N-0345-EC162 - TEXT
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.2>The FDA should allow for the dispensing of selected drugs without a prescription by a
licensed pharmacist, physician's assistant, or nurse practitioner.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.1, 7.3.1.1>Yes, if the non-prescription sale was made through a licensed pharmacy and by a
licensed pharmacist, PA, or NP.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.1, 7.4.1>It would be quite simple, as indicated in section A above, to limit the non-prescription sales
via a state-licensed pharmacist. Other drugs that would also be appropriate for this third level of
dispensing would be NSAIDS, HMG-CoA reductase inhibitors ("statins"),oral contraceptives,
pseudoephedrine, St John's wort, kava, and seasonal allergy medications.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.1>Yes
COMMENT NUMBER - 2005N-0345-EC16427
2005N-0345-EC16427 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 173 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 165
Commenter Organization Name: Marcelli, Christian
2005N-0345-EC16427 - TEXT
GENERAL
<1: 3.9.1>There are already products sold both OTC and via Rx. Ibuprofen is one of them. This has been
relatively safe considering the vast benefit to society. <2: 1.2.2>Plan B has a further reaching
benefit to society given the long term effects of pregnancy or abortion. A product should be sold over the
counter when it is safe to do so. Restrictions should not be made for religious or political reasons,
otherwise we will have vastly different drug regulations when new administrations take office.
COMMENT NUMBER - 2005N-0345-EC165
2005N-0345-EC165 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Reusch, Elizabeth
2005N-0345-EC165 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.1>Yes, this would help to determine the product packaging and restriction labeling requirements
needed between a drug sold as a prescription and one sold over the counter. In many instances, the
information received with prescriptions is more complete and informative.
1.
C. If so, would a rulemaking on this issue help dispet that confusion?
Unknown.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.1, 6.6.3>Yes, limitation of products by age are common in the United States for the sale of lottery
tickets, alcohol, cigarettes, even movie tickets by requiring the presentation of a legal identification. A
movie rated R is restricted from teenagers buying the product; A lottery ticket is restricted to those over
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the age of 21 (Arizona law); cigarettes are restricted to those over 18; alcohol is restricted to those over
21. Age restrictions are used throughout this nation to limit exposure to products.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.1, 7.4.4>By requiring an identification card be presented at the time of purchase.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.6.2>In my personal opinion, a product sold over the counter and then as a prescription should NOT
be legally sold in the same package. This can create confusion and anxiety about where and how a
product was obtained. Many prescriptions are filled in standard prescription bottles.
GENERAL
GENERAL
<5: 6.7>Yet, the age restriction would create a problem with obtaining the product via healthcare
prescription plans that do not normally cover over the counter drugs.
COMMENT NUMBER - 2005N-0345-EC16543
2005N-0345-EC16543 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Jones, Kim
2005N-0345-EC16543 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
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No (this is the same question)
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2, 4.4.2>No. The American consumer understands that some medications are reasonably safe for
self-medication in lower doses, but require physician monitoring for higher doses and certain uses.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 4.2>There is no confusion.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2, 6.5.4>No. It would implicate equal protection rights, among other problems.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2, 7.5.4>No. Looking, for example, at minors, if minors can obtain cigarettes and alcohol, they will
be able to obtain OTC medications as well.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1>Yes
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
I have no comment
GENERAL
GENERAL
<7: 1.2.1, 2.1>The present rulemaking procedure should not delay the approval of Plan B for OTC sales.
There is no credible reason to apply different rules regarding this contraceptive medication to different
subpopulations. There is no evidence that its effects are different on different subpopulations, nor that it is
any less safe for one subpopulation. The decision to consider different rules for different subpopulations
is a purely political decision, which is inappropriate when it comes to the FDA's charter to ensure the
safety and health of the American consumer. The FDA should follow nearly unanimous guidance and
immediately approve Plan B for OTC sales for all individuals. The present rulemaking process can
continue, but need not delay the immediate approval of Plan B for OTC sales, because there is no need to
explore the simultaneous marketing approach for this safe and effective product.
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COMMENT NUMBER - 2005N-0345-EC16546
2005N-0345-EC16546 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Saling, Elle
2005N-0345-EC16546 - TEXT
GENERAL
<1: 6.5.1>If a drug is safe and helps people and if it is not habit forming it should be made available. It is
not up to the FDA to make moral or ethical judgements on drugs, if it was Viagra should never have
received approval. It is up to the FDA to determine the safety of the drug. This particular drug is not a
narcotic, it is as safe as aspirin and yet since it relates to women and this current administration has rallied
around denying women rights to their own health and safety, this is the reason it is being held up. It is up
to each and every individual citizen to determine what medications they will or will not use. This once
free country becomes more and more like Russia and China everyday. <2: 3.9.1>Pepcid AC is
sold as both prescription and over the counter as is Motrin. <3: 1.2.1>This drug, regardless of
it's intended use falls under the same right to privacy as the two noted above. Americans are not children.
Under the current HMO and health system crisis we are forced to make decisions about our personal
health every single day. To use or not use this drug should be up to the people. Holding it back is
unethical and immoral and just plain wrong.
COMMENT NUMBER - 2005N-0345-EC16675
2005N-0345-EC16675 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: American Pharmacists Association
2005N-0345-EC16675 - TEXT
GENERAL
See Attachment
2005N-0345-EC16675-Attach-59.DOC
2005N-0345-EC16675-Attach-60.PDF
ATTACHMENT:
American Pharmacists Association
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Improving medication use. Advancing patient care.
APhA
October 31, 2005
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: Docket No. 2005N-0345
Dear Sir/Madam:
Thank you for the opportunity to comment on the September 1, 2005 Federal Register notice addressing
circumstances under which an active ingredient may be simultaneously marketed in both a prescription
drug product and an over-the-counter drug product. The American Pharmacists Association (APhA),
founded in 1852 as the American Pharmaceutical Association, represents more than 53,000 practicing
pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested
in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and
advance patient care, is the first-established and largest association of pharmacists in the United States.
The Food and Drug Administration (FDA) is soliciting public comments on several regulatory and policy
issues related to the Agency's process to classify drug products as "prescription" or "over-the-counter"
(OTC). Specifically, the Agency is interested in examining its authority under the Federal Food, Drug,
and Cosmetic Act (the Act) to simultaneously approve an active ingredient as both a prescription and
OTC. The Agency is also looking at related issues including its ability to enforce sales limitations of
OTC products and the marketing of "dual status" products in a single package. APhA appreciates the
Agency's decision to conduct an open evaluation of these regulatory and policy questions and we
welcome the opportunity to add our comments to the discussion. <1: 3.2, 3.8.5>Please note that APhA is
not responding to these questions in the context of a single drug product; rather, we are providing our
comments on the overall "dual status" issue which could apply to any number of drug products. As such,
pending issues need not necessarily be resolved by rulemaking before the Agency acts on a specific
pending application.
APhA offers the following comments on the questions for public comment included in the Federal
Register notice.
1A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously marketed in both a prescription drug product and an
OTC drug product?
<2: 3.1>Yes, APhA would support efforts by the FDA to codify the Agency's interpretation of Section
503(b), the Federal standard used to classify drug products as prescription or OTC.
<3: 3.8.2>In simplest terms, if a drug does not meet the definition of prescription drug product from
Section 503(b) , it must be an OTC. However, there may be drug products in which the standard two
class system is not sufficient. For example, certain drug products may not distinctly fall into the
"prescription" or "OTC" class - the active ingredient could be considered both a prescription and an OTC
if some meaningful difference exists between the products. In other circumstances, certain drug products
may not require the assistance of a learned intermediary (the deciding factor in classifying a drug as a
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prescription), yet patients would still benefit from access to a health care professional's services when
selecting and using the product. Such access may not always be available with "full" OTC status.
<4: 3.8.1>While the Agency's proposal to codify its interpretation of Section 503(b) would only directly
address the situation in which an active ingredient can be marketed as both a prescription and as an OTC
because of a meaningful difference between the products, it is important for the FDA to formalize its
interpretation of the statute on this point. And activities to formalize the Agency's interpretation may also
provide the opportunity to engage in a discussion about expanding the current classification system of
medications beyond only prescription and OTC.
<5: 3.8.1>The realities of our current health care environment underscore the need for the FDA to clarify
its interpretation of Section 503(b) and participate in an open discussion of the drug classification system.
Over the past decade, a number of prescription products have made the switch to OTC status. A non-
sedating antihistamine, a full strength H2 receptor antagonist, and a proton-pump inhibitor have all made
the transition to OTC. And with the support of consumers, manufacturers, and regulators, all indications
point to even more products making the move - including products for asymptomatic conditions such as
osteoporosis or dyslipidemia. As the number of "switch" applications increase, so will the potential for
active ingredients that may best be simultaneously classified as both a prescription and an OTC, or placed
in some type of in-between or transition category. An examination of the current two class system and
codification of the FDA's interpretation of Section 503(b) will aid the Agency and product sponsors with
future switch requests, and will facilitate the transition of appropriate products to OTC status, ultimately
providing consumers with greater access to safe and effective medications.
1B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<6: 4.1>There is some confusion regarding the Agency's interpretation of the statute.
<7: 4.3.4>As the FDA has acknowledged, the Agency's interpretation of Section 503(b) has not been
explicitly set forth in any regulation that addresses the drug classification process. [Footnote 1: 70 FR at
52,051.] Without an official interpretation in the Act or implementing regulations, manufacturers, health
care professionals, state regulatory bodies, and even FDA officials, may not have a concrete
understanding of the Agency's process to classify, or in some cases, reclassify, drugs as prescription or
OTC.
<8: 4.3.2>The confusion has also been evidenced recently in the reaction to the Agency's decision to seek
public comment on these regulatory issues. After the Agency's announcement, members of the private
sector began making public, and conflicting, pronouncements on whether the FDA currently has the
authority to approve a product as both a prescription and as an OTC, how the Agency has handled similar
approvals in the past, and what restrictions, if any, the Agency can place on such approvals. The differing
opinions on these issues illustrate the need for clarification of Section 503(b).
1C. If so, would a rulemaking on this issue help dispel that confusion?
<9: 5.1>Yes, a well developed regulation that codifies the Agency's interpretation of Section 503(b)
should reduce confusion.
2A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
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<10: 6.1>Yes, as a matter of law, the FDA can enforce a subpopulation limitation on the sale of an OTC
product.
<11: 6.4.1, 7.3.1.1, 7.3.1.2>The Agency currently enforces a sales limitation on the over-the-counter
smoking cessation product Nicorette (nicotine polacrilex). As part of the drug's conditions of approval,
the FDA, in conjunction with the product sponsor, restricted the product to individuals 18 years of age of
older. According to the approval letter, "The product cartons must bear the legend: Not for sale to those
under 18 years of age. Proof of age required. Not for sale in vending machines or from any source where
proof of age cannot be verified." [Footnote 2: Food and Drug Administration. Letter to Hoechst Marion
Roussel, Inc. February 9, 1996.] To help ensure that the product is not distributed to underage
individuals, the product sponsor also implemented a marketing plan that restricts product distribution to
pharmacies, mass merchandisers, and supermarkets where other OTC drugs are sold. The product is not
distributed through convenience stores or vending machines. Retailers were also trained on the product's
age restriction. According to the product sponsor, retailers are responsible for enforcing the age
restriction, and each retailer has flexibility in developing its own system to verify a purchaser's age.
[Footnote 3: Plan B Debate May Spotlight Smoking Cessation Age Limit Precedent. The Tan Sheet.
September 5, 2005.]
<12: 6.4.1>Through its approval of Nicorette(TM), the Agency established a precedent for approving a
drug product as an OTC and restricting its availability to a limited population. While the situation under
consideration by the FDA - approving a drug as an OTC for one subpopulation and making it a
prescription for another subpopulation - is different, the underlying premise remains that same; the
Agency could enforce a sales limitation on products available as an OTC. To do so, the Agency could
include the sales restriction as a condition of approval and work with the product sponsor to craft labeling
that reflects the restriction. Including the conditions for sale in the product labeling and approving the
product labeling enables the FDA to enforce a sales restriction for an OTC. It is important to note that if
the Agency includes a sales restriction as part of the conditions of approval for a drug product, any
generic products subsequently approved for marketing would also have to be approved under those same
terms and abide by the same requirements. [Footnote 4: Comments of Dr. Edwin Hemwall and Dr. Jonca
Bull. Transcript of the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory
Committee and Non-Prescription Drugs Advisory Committee Hearing on Over-the-Counter Use of
Mevacor (lovastatin). January 14, 2005. Pgs. 82 - 84. ]
2B. If it could, would it be able to do so as a practical matter and, if so, how?
<13: 7.1>Yes, there are practical means available for the FDA to enforce a sales limitation on OTC
products. APhA offers the following recommendations for the Agency's consideration.
<14: 7.3.1.1, 7.3.1.2>As discussed above, the Agency can enforce a sales limitation through regulation of
the product sponsor. If the Agency, in conjunction with the product sponsor, determines that a sales
limitation is appropriate, the FDA can require the sales restriction through the approved labeling as part of
the conditions of approval. This process would mirror the conditions of approval for Nicorette although
the particular sales restriction (i.e., age, sex, etc.) could vary. The product sponsor could also be required
to educate retailers about the sales restriction. Ultimately the product sponsor and retailer, not the FDA,
would be responsible for ensuring that the product is supplied according to its approved labeling. As with
any other OTC product, the FDA would not be responsible for policing any off-label use of the
product.
<15: 7.4.1>Following the Nicorette example, a product with an OTC sales restriction should only be
distributed in retailers where other OTC drugs are sold and in settings where the retailer can verify that
the purchaser meets the conditions for sale, such as verifying the purchaser's age. However, in situations
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where the product would also be available as a prescription and presented in the same package, the
product should be further limited to settings licensed to provide prescription drug products; by definition,
"dual status" products should be limited to entities with a pharmacy or other dispensing environment. By
limiting the product to an entity with a pharmacy, the entity can verify that individuals seeking the OTC
product meet the sales restriction criteria and a pharmacist can dispense the product to individuals who do
not meet the sales restriction pursuant to a valid prescription. This approach navigates the challenge of
enforcing the federal prescription requirement.
<16: 7.4.1>Restricting a dual status product to entities with a pharmacy will also allow consumers
seeking input from a health care professional to have ready access to that advice. Dual status products
would work well within the Pharmacy Care OTC concept (See Attachment A). Pharmacy Care OTCs are
a sub-category of non-prescription medicines available only in outlets with pharmacies to facilitate
interaction between consumers and pharmacists. Like other OTCs, Pharmacy Care OTCs would be
available in pharmacies on the open shelf with other over-the-counter medications. What is different with
Pharmacy Care OTCs is the availability of the pharmacist and the marketing, product placement, and
pharmacist preparation to support consumer/pharmacist interaction. Pharmacist intervention is not
required but strongly supported for Pharmacy Care OTCs - such as products being used for chronic,
asymptomatic conditions or other conditions where consumers would benefit from additional interaction
with their pharmacist. The FDA could place OTC products in the Pharmacy Care OTC category through
an interpretation of current law; the Pharmacy Care OTC category would not require a statutory
change.
<17: 7.4.1>If the FDA would prefer to amend the Act, the Agency should consider creating additional
classes of drugs. APhA has long called for the establishment of an option that would call on pharmacists
to play a greater role in expanding access to designated medications. Under an expanded drug
classification system, designated products could be dispensed without a prescription order; however, the
product would only be dispensed by pharmacists. Such availability would expand access beyond the
traditional system, while maintaining health professional interaction. Requiring consumers to consult
with pharmacists to obtain the product can be valuable in ensuring appropriate medication use, reducing
adverse events, and ensuring consumer persistence and compliance with therapy. A so-called "pharmacist
only" class has been used successfully in a number of countries including the United Kingdom, Canada,
Australia, New Zealand, and Singapore. [Footnote 5: Robert Field, JD, MPH, PhD. Support Grows for a
Third Class of "Behind-the-Counter" Drugs. Pharmacy & Therapeutics. May 2005. Pg. 261.] For
example, the United Kingdom recently moved the cholesterol drug Zocor™ (simvastatin) over-the-
counter; however, consumers must obtain the product from a pharmacist. Pharmacists in Great Britain
can supply the drug to consumers following simple health checks such as asking about their health and
offering various health tests to ensure that it is safe to dispense the medication. A cholesterol test may be
offered but it is not mandatory. This example illustrates the benefits of an expanded drug classification
system - consumers experience increased access to a relatively safe drug, but some level of professional
involvement remains.
<18: 3.3.3, 6.3.1, 7.3.1.3>If the FDA approves a product for inclusion in the Pharmacy Care OTC
category or for placement within a statutorily-established expansion of the drug classification system,
either option could be supplemented, when necessary, with some form of postmarking risk management
program. Subpart H of the Act gives the Agency the authority to approve a product with restrictions to
assure safe use "if the FDA concludes that a drug product shown to be effective can be safely used only if
distribution or use is restricted." [Footnote 6: 21 CFR 314.520] The restrictions can include distribution
restricted to certain facilities or physicians with special training or experience; distribution conditioned on
the performance of specified medical procedures; or limitations imposed that are commensurate with the
specific safety concerns presented. [Footnote 7: Ibid.] The Agency can place these postmarketing
restrictions on both prescription and OTC products. The Agency could use its authority under Subpart H
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to require a risk management program - such as distribution restricted to a pharmacy or entities with a
pharmacy or requiring additional education on product use - for products that have been approved with a
dual status because the Agency has concluded that the drug may only be safely used in a particular
subpopulation as a prescription product.
3A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product,
may the different products be legally sold in the same package?
<19: 7.4, 8.4.1>Yes, an active ingredient that is marketed as both a prescription and OTC product may
legally be sold in the same package if the following conditions are met:
1. The product sponsor develops a product label and packaging that is appropriate for both the
prescription and the OTC environment; and the FDA approves the product labeling.
2. The product is only sold in settings licensed to provide prescription drug products. Because the
characteristics of the potential user of the product determines whether or not a dual-status product is
prescription or OTC, dual status products should be presumed to be a prescription and limited to outlets
with appropriate licensing to dispense medications. Such outlets, then, must develop policies and
procedures to comply with prescription requirements to avoid selling medications to individuals who
would require the prescription product.
3B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<20: 8.7, 9.1.1>It would be inappropriate to market a dual status product in the same package in the
following circumstances:
1. The products have truly different indications such as the Meclizine (prescription for vertigo/OTC for
nausea with motion sickness) example provided in the Federal Register notice.
2. The products have different strengths, dosage forms, routes of administration, or directions for
use.
<21: 4.3.2>In closing, we would like to reiterate our appreciation for the opportunity to contribute to the
public dialogue on these important regulatory and policy issues. There is a great deal of confusion
regarding the FDA's process for classifying drugs as prescription or OTC, and the level of confusion has
increased dramatically in recent months as the Agency has discussed the concept of simultaneously
approving drug products as both prescription and OTC. <22: 5.1>Codifying the Agency's
interpretation of Section 503(b) would be a step towards dispelling that confusion. <23:
7.4>As the Agency reviews comments and evaluates the need for additional rulemaking, APhA urges the
Agency to consider limiting "dual status" products to entities with a pharmacy. We also recommend that
the FDA consider the need for an alternative to the current "prescription" and "OTC" classification system
such as the Pharmacy Care OTC concept or expanding the drug classification system by amending the
Act. Either of these systems would significantly increase access to designated medications, while
ensuring some level of access to or oversight by pharmacists - the medication experts on the health care
team.
Thank you for your consideration of the views of the nation's pharmacists. Please contact Susan K.
Bishop, Associate Director, Regulatory Affairs, at 202-429-7538 or SBishop@APhAnet.org, or Susan C.
Winckler, Vice President, Policy & Communications and Staff Counsel, at 202-429-7533 or
SWinckler@APhAnet.org, with any questions.
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Sincerely,
John A. Gans, PharmD
Executive Vice President
cc: Susan C. Winckler, RPh, Esq, Vice President, Policy & Communications and Staff Counsel
Susan K. Bishop, MA, Associate Director, Regulatory Affairs
<24: 10>APhA Pharmacy Care OTC Task Force
Report of Opening Meeting
The movement of products from prescription to over-the-counter (OTC) status is a reality of our health
care environment, a reality intended to increase consumer access to safe and effective medications. In the
past few years, a non-sedating antihistamine, a full strength H2 receptor antagonist, and a proton-pump
inhibitor have made this transition from prescription to OTC status. With the support of consumers,
manufacturers, and regulators, all indications point to even more products making the move ? including
products for asymptomatic conditions like osteoporosis or high cholesterol. As a component of these
discussions, the American Pharmacists Association (APhA) is exploring the concept of enhancing the role
of pharmacy through increased encouragement of consumer-pharmacist interaction and distributing some
OTCs exclusively in outlets with a pharmacy, creating a new category of these products: Pharmacy Care
OTCs. The combination of expanding consumer access to these products in the OTC area of the
pharmacy and providing access to the pharmacist for assistance is powerful and helpful. Consumers
seeking access to the product in the pharmacy would have ready access to the product, and those seeking
input from the medication expert on the health care team-their pharmacist-would have ready access to that
advice.
In August 2004, the American Pharmacists Association convened a Task Force to discuss these issues and
develop recommendations for incorporating additional OTC products into pharmacy practice and
implementing the Pharmacy Care OTC category. Task Force members (identified in Attachment A)
include representatives from independent and chain community pharmacy practice, managed care,
academia, and pharmacy management. Pharmacy Care OTCs are a sub-category of non-prescription
medicines available only in outlets with pharmacies1 to facilitate interaction between consumers and
pharmacists. [Footnote1: A 'pharmacy' is facility, licensed and designated by appropriate state regulators
as a pharmacy, where drugs or devices are dispensed and/or pharmacist services are provided.] These
medications may be used for chronic, asymptomatic conditions or other conditions where consumers
would benefit from additional interaction with their pharmacist. Pharmacy Care OTCs can provide
significant benefit to consumers, who may also benefit from the expertise of pharmacists to help them
effectively utilize these products. This category presents an opportunity for consumers to have greater
access to important medications that can benefit their health while using the medication expertise of
pharmacists to help consumers use those medications appropriately.
Task Force Mission Defining a "Pharmacy Care OTC" Category
Moving products from prescription to OTC status affects pharmacy practice in many ways, including
pharmacists' efforts to coordinate and monitor medication use, the need to prepare pharmacy personnel
for the product shift, and the financial impact of the shift. OTC products designated as Pharmacy Care
OTCs will require additional thought and planning on the part of the manufacturer, pharmacists and
facility staff. The Task Force mission included providing advice to the profession of pharmacy and other
stakeholders on helping consumers make the best use of Pharmacy Care OTC medications.
Objective
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The task force discussed this new category and developed guiding principles for implementation of the
category. The task force made recommendations (provided below) on issues such as:
Necessary training and education of pharmacy personnel and facility staff to support
pharmacist/consumer interaction, including providing consumer education materials.
Considerations in selling such products, including access to pharmacy personnel, product placement, and
support services such as in-pharmacy point-of-care testing.
Recommendations
The APhA Task Force on Pharmacy Care OTCs recommends manufacturers, pharmacists and pharmacies
consider the following when choosing to provide Pharmacy Care OTCs. Task Force recommendations
are meant to be flexible, allowing for individualization within a specific pharmacy practice setting.
Management of the Pharmacy Care OTC Category
Products in this category should demonstrate a proven health benefit.
Availability as a Pharmacy Care OTC is recommended only for certain appropriate products where
consumers will benefit from increased access to a pharmacist. The Task Force urges the development of
criteria to identify those types of products that would benefit from this category.
Guidelines for patient identification and risk assessment should be available.
Information about appropriate populations and necessary risk assessment procedures should be provided
in product labeling, as well as in educational material for pharmacists.
Supporting Consumer/Pharmacist Interaction
Product placement and promotion should support direct interaction with the pharmacist.
Pharmacy Care OTCs present an opportunity for consumers to easily access important medicines and ask
questions of their pharmacist. To facilitate that interaction, consumers must have direct access to
pharmacists, access that is supported by product placement, promotion, workflow, and staffing patterns.
Business models should support providing these services. Marketing approaches (e.g., print ads, shelf-
talkers, etc.) should direct consumers with questions to their pharmacist; some facilities may choose to
position a pharmacist in the OTC area to offer assistance. As a contingency in those outlets that remain
open when a pharmacist is not on duty, such as a grocery store or mass merchandiser, methods to provide
access to counseling and education should be developed, including alternatives to face to face approaches,
such as use of the telephone and the internet. (Pharmacist availability will be consistent with state
requirements for pharmacy licensure.) Appointment systems should be considered if the consumer
requests lengthy consultations or if the pharmacy environment is not always conducive to
consumer/pharmacist interaction.
Facility staff should be educated about Pharmacy Care OTCs.
When the pharmacy is one component of the facility (e.g., a grocery store or mass merchandiser),
appropriate non-pharmacy staff should be educated generally about Pharmacy Care OTCs so that they
may direct consumers to the pharmacy area and advise them of the pharmacist's availability for
consultation..
Education about Pharmacy Care OTCs and specific products included in the category should be provided
though the media, marketing, pharmacists, and pharmacies.
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Scope of Consumer/Pharmacist Interaction
Pharmacy staff should be educated and trained about the product and the appropriate population for
product use.
Pharmacists are responsible for responding to consumer inquiries. Pharmacists, student pharmacists,
technicians and others working in the pharmacy should be educated about the product and condition being
treated, risks, appropriate monitoring, and follow-up; as well as procedures for responding to consumer
inquiries and referring consumers to other health care professionals, as appropriate. Such education and
training is important to adequately prepare pharmacists to deliver these services.
Pharmacist/consumer interaction includes:
identifying consumers who should use the medication,
identifying consumers who should be referred to another health care professional, and
providing appropriate support.
Consumer/pharmacist discussion may encompass screening activities as well as consultation at the point
of purchase. Recommendations for consumer use should be consistent with product labeling and clinical
guidelines, where available. For consumers using Pharmacy Care OTCs for chronic conditions, the
consumer/pharmacist interaction may include ongoing support, such as compliance monitoring and
monitoring for therapeutic endpoints.
Other Services
Support services should be available or referral information provided.
Some Pharmacy Care OTCs may require point-of-care testing to identify appropriate consumers and
monitor consumer progress. Where such services are not available in the pharmacy facility, referral
information should be provided.
Documentation of Pharmacy Care OTCs in the patient profile is encouraged.
Pharmacy Care OTCs facilitate documentation of product use, supporting drug/drug interaction screening,
protection against drug/disease contraindications, and outcome monitoring. Consumers should report use
of Pharmacy Care OTCs to their pharmacist and their doctor or other prescriber. Pharmacists who sell
Pharmacy Care OTCs should recommend and request consumer approval to add these products to their
medication profile. Consumers and pharmacists share in the decision-making for communicating
information about their use of Pharmacy Care OTCs with the primary physician providing their
healthcare.
APhA Pharmacy Care OTC Task Force* [*Task Force participants served as individuals. This report
does not necessarily represent the opinions of their organizations. ]
Pam Bernadella, RPh
Target Pharmacy
Minneapolis, MN
Rebecca Burkholder, JD
National Consumers League
Washington, DC
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Rebecca Cupp, RPh
Ralphs Grocery Company
Compton, CA
Jan Engle, PharmD, FAPhA
University of Illinois at Chicago
College of Pharmacy
Chicago, IL
John Fegan, RPh
Ahold, USA
Braintree, MA
Doug Hoey, RPh, MBA
National Community Pharmacists Association
Alexandria, VA
Terry Maves, RPh
Touchpoint Health Plan
Appleton, WI
James McKenney, PharmD
National Clinical Research
Richmond, VA
Warren A. Narducci, PharmD, RPh, FAPhA
Nishna Valley Pharmacy
Shenandoah, IA
Brian Przyzycki, RPh
Walgreens Health Initiatives
Deerfield, IL
Jairo Ramirez, RPh
Kaiser Permanente-Colorado Region
Aurora, CO
Rob Seidman, PharmD, MPH
WellPoint Health Networks
Thousand Oaks, CA
Steve Simenson, RPh
Goodrich Pharmacy
Ramsey, MN
Ed Staffa, RPh
National Association of Chain Drug Stores
Alexandria, VA
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COMMENT NUMBER - 2005N-0345-EC167
2005N-0345-EC167 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Blume, John
2005N-0345-EC167 - TEXT
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 3.7.2>It depends on the subpopulation. It would probably be difficult to do it based on race for
example, but not based on age. Although certain drugs seem to be more effective on certain races I don't
see how somebody selling a drug is supposed to determine the buyers race. However, age limitations are
common.
B. If it could, would it be able to do so as practical matter and, if so, how?
<2: 7.4.4>Yes, depending upon the subpopulation, With age, identifications could be checked or in my
comments below I also have a possible alternative solution.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<3: 8.1>Yes, but see my comments below.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<4: 9.2.2>I don't see any.
GENERAL
GENERAL
Instead of answering the questions I omitted above,I am going to answer the questions in your letter.
<5: 1.2.1, 6.5.1>1. Can age be used as a criterion on which we decide whether a drug should be
prescription or over-the-countger, as has been proposed in this case (Plan B)?
Yes. However, I suspect that political pressure may be at play here. If that is the case, it is inappropriate.
The FDA should be considering whether an age limit would be justified based on the safety of the product
for the given age group, not based on their or anyone else's moral beliefs. I can easily believe that certain
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drugs are safer for certain age population than for others. I am not in the field of medicine and therefore
do not feel qualified to say whether or not this drug is safe for those under 16. If it is, make it over-the-
counter for all age groups and let parents do their job of raising their own kids.
<6: 8.4.1, 8.6.2, 9.1.1>Can the prescription and over the counter version of the same drug be marketed in
a single package? I don't see why not. I don't see how that could do any harm if they are to be used in the
same way and contain the same dosage of the same medicine. In fact, it might be more dangerous to
market them in different packages, which could lead some people to believe that the over-the-counter
version is different in that it is safer. However, if you see a reason that it would actually be more
dangerous to market them in the same package, I don't think it would be much of a burden on the drug
company to make two different packages.
<7: 7.4.4, 7.4.6>If we do use age as the only criterion on which we decide whether a drug is sold as a
prescription product, or over the counter product, how as a practical matter would such a limitation be
enforced?
The cashier could ask for identification just like is done when somebody buys alcohol or tobacco
products. Also, I don't know exactly what information pharmacies already have in their computer systems
about patients, but if age is one they could check their computers or if it is not, it could be something that
doctors could supply. This, of course, would mean that the drug would have to be sold only where
prescriptions drugs were sold, but that it could be bought without the prescription.
COMMENT NUMBER - 2005N-0345-EC16770
2005N-0345-EC16770 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Subcommittee on Criminal Justice, Drug Policy
2005N-0345-EC16770 - TEXT
GENERAL
See Attachment
2005N-0345-EC16770-Attach-62.DOC
Docket Number and Title: 2005N-0345 - Drug Approvals: Circumstances Under Which an Active
Ingredient May Be Simultaneously Marketed In Both a Prescription Drug Product and an Over-the-
Counter Drug Product
RIN Number: 0910-AF72
FR Type: Advanced Notice of Proposed Rulemaking
Action: Other
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Comment Period End Date: November 1, 2005
Comments Submitted by: The House Subcommittee on Criminal Justice, Drug Policy and Human
Resources,
Committee on Government Reform
B-377 Rayburn House Office Building
Washington, DC
202-225-2577
Barr Pharmaceuticals has proposed that Plan B be marketed both prescription and over-the-counter (OTC)
in a single package. This presents several new significant legal and regulatory questions for FDA.
The statute under question is §503(b)(1) of the Federal Food, Drug and Cosmetic Act. To date, FDA has
interpreted that statute to allow marketing of the same active ingredient in products that are both
prescription and OTC only if there is "a meaningful difference between the two that makes the
prescription product safe only under the supervision of a licensed practitioner." By "meaningful
difference," FDA means a difference regarding indication, strength, route of administration, dosage form,
etc…that makes the prescription product safe only under the supervision of a licensed physician.
I. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously marketed in both a prescription drug product and an
OTC drug product?
<1: 3.1>Yes. <2: 3.8.1>It is crucial that FDA continue and codify its current interpretation of
this law. FDA has set a consistent standard, the "meaningful difference" standard, which the American
public and pharmaceutical companies have relied upon. If FDA codifies its current interpretation, this
provides a further service to the public and to pharmaceutical companies, as this would give FDA's future
decisions clarity and meaning.
A. It is potentially unlawful and against public policy for FDA to market the same drug both prescription
and OTC in the same package.
<3: 6.5.4>In light of FDA's longstanding and well-established interpretation of this statute, there are no
bases, legal or otherwise, for allowing marketing of the same active ingredient in a drug both OTC and
prescription. Barr has proposed that FDA interpret 503(b) in a completely different way than it ever has
before. Neither Barr nor FDA has given any substantial justifications for why FDA would suddenly
change its interpretation for such a controversial, and in many ways, untested, drug. In fact, FDA's
reconsideration of its established interpretation in this situation is confusing at best, both in terms of how
FDA uses information and data to make policy decisions, and what standards FDA uses to create
interpretations of law that are completely contrary to its prior interpretations.
<4: 3.4>Furthermore, FDA is constrained to act in accordance with the APA's mandate to refrain from
any agency activity that is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with the law." [Footnote 1: See APA §706(2)(A).] In determining what constitutes "arbitrary" agency
action, administrative case law has consistently held that a court will intervene if it "becomes aware,
especially through a combination of danger signals, that the agency has not really taken a 'hard look' at the
salient problems, and has not genuinely engaged in reasoned decision making." [Footnote 2: See Greater
Boston Television Corp. v. FCC, 444 F.2d 841, 850-852 (D.C.Cir.1970).]
<5: 3.4>It appears clear that FDA has not taken a hard look at the salient problems which surround
changing its interpretation of the statute. Plan B, the drug which FDA has decided to use towards
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considering changing its interpretation, is one of the most controversial drugs on the market. Barr
Pharmaceuticals has also experienced a long history of falling far short of FDA's testing and safety
standards regarding this drug. [Footnote 3: See, e.g.,
http://www.fda.gov/cder/drug/infopage/planB/planB_NALetter.pdf (accessed Oct. 27, 2005).] To date,
Barr has not rectified this situation; there is still a troubling shortage of clinical data on Plan B as to safety
and effectiveness, particularly involving young adolescent women. [Footnote 4: See
http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm (accessed Oct. 27, 2005).] This
disturbing state of facts surrounding FDA's actions is the very definition of a "combination of danger
signals" surrounding agency action. In a more general sense, if FDA allows simultaneous marketing of
any active ingredient in a drug both prescription and OTC, thus interpreting its rule in a way directly
contradictory to its past interpretation, without any apparent justification whatsoever, that easily
constitutes arbitrary and capricious agency action.
<6: 3.8.4>Additionally, to allow FDA to change its interpretation of this statute or to allow an exception
to its current interpretation for Plan B is against public policy. It not only opens the door to instability in
the way agencies interpret their own statutes, but also leads to significant public doubt as to how FDA
interprets its own rules. How does FDA serve the American public by arbitrarily changing its statutory
interpretation merely at the behest of a pharmaceutical company, which furthermore provides insufficient
data to support its request? As an executive agency that ultimately serves the American people, FDA
must pay careful attention towards maintaining consistency in its interpretations of law, especially in
situations like this where there is little evidence-medical or legal-which would support a change in FDA's
existing interpretation.
II. Using age as the criterion for determining whether a drug is marketed as prescription or OTC is
arbitrary and dangerous.
<7: 1.2.3, 6.5.4, 7.5.3>One of FDA's prime concerns is that there appears to be no way to ensure that
women under 16 years of age will not have access to Plan B OTC. This unanswerable problem highlights
the overarching flaws inherent in allowing age as the criterion to determine whether a drug is prescription
or OTC.
<8: 1.2.3, 6.5.4>The age requirement is arbitrary. FDA has not explained this requirement and appears to
have no basis for it. And to date, Barr Pharmaceuticals has submitted no credible, scientific evidence as to
why it wants this arbitrary age distinction to determine how Plan B will be marketed. Barr has only stated
that allowing Plan B OTC will make Plan B more available. As a stated reason, this is empty and
ineffective. There are countless drugs which would be more accessible if patients could obtain them OTC.
That hardly provides a justification for completely changing a long-established agency interpretation.
Moreover, Barr has performed no studies to determine the safety and effectiveness of Plan B in patients
younger than 14, and has based its request for girls age 14-16 on a sample of only 29 girls. [Footnote 5:
See http://www.go2planb.com/PDF/PlanBPI.pdf. (emphasis added) Accessed October 18, 2005.] Barr
states on Plan B's website that "safety and efficacy of progestin-only pills have been established for
women of reproductive age for long-term contraception. Safety and efficacy are expected to be the same
for postpubertal adolescents under the age of 16 and for users 16 years and older." [Footnote 6: Id.] So,
in effect, Barr is hazarding a guess that Plan B will be safe for minors. Nor has Barr performed any
research either on overdosage or on dependence on Plan B. Effectively, Barr has provided wholly
inadequate research or no research at all to support its request to make Plan B available OTC.
<9: 7.5.3>FDA is correct in its concern that there appears to be no way to ensure that women under 16
will not have access to Plan B OTC. Providing Plan B OTC appears to negate the need for using
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traditional channels to obtain a prescription. Furthermore, there are no existing incentives for women
younger than 16 to obtain Plan B prescription only. It will be cheaper and easier for minors to obtain Plan
B OTC. It is also more expedient to obtain Plan B OTC, which is a key factor in the case of emergency
contraception. In effect, a ruling allowing Plan B OTC would mean that women under the age of 16 will
be obtain Plan B without a prescription in a number of ways. They may have their older friends buy it for
them, or even their parents. If FDA has imposed the arbitrary line of age 16 as to when Plan B OTC is
safe, who is to say that parents will not just decide for themselves that it is perfectly safe for their minor
daughters to take Plan B OTC? <10: 6.3.4>Furthermore, it would be nearly impossible for
concerned family members to detect the use of Plan B underage. As to the enforcement concern, Barr has
not presented FDA with even a semblance of enforcement mechanisms for ensuring compliance with its
age requirement.
<11: 1.2.3>Two, Plan B may act as an abortifacient, which initiates its own subset of legal questions.
Barr states on the Plan B website that "Plan B is believed to act as an emergency contraceptive principally
by preventing ovulation or fertilization. In addition, it may inhibit implantation (by altering the
endometrium)." [Footnote 7: Id.] Needless to say, there is some confusion as to the actual mechanism
Plan B employs. If it truly acts as an abortifacient, this presents even more compelling safety and public
policy reasons to restrict its use to prescription.
<12: 3.1>For the foregoing reasons, we strongly suggest that FDA codify its current interpretation of
§503(b)(1) of the Federal, Food, Drug and Cosmetic Act.
ATTACHMENT FROM COMMENT EMC0462:
Ms. Butler,
Attached is a letter clarifying that the Subcommittee's comment on Plan B. <13: 8.2>Our comment said it
is against public policy and potentially unlawful to market the same drug as both prescription and OTC in
the same package. As the attached letter explains, this is the view of the Majority side of the
Subcommittee only. Thank you for your assistance in allowing us to clarify the attribution.
Best,
Michelle Gress
Counsel
Subcommittee on Criminal Justice, Drug Policy and Human Resources
Government Reform Committee
U.S. House of Representatives
202.225.2577
202.225.1154 (fax)
http://reform.house.gov/CJDPHR/
<<11.16 letter to FDA Dockets Management Branch.pdf>>
Jennie Butler
Director
Dockets Management Branch
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Via email to jbutler1@oc.fda.gov
Re: Comment Number EC16770
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Dear Ms. Butler:
This letter is to clarify that the comment submitted to the FDA on November 1 (Docket Number 2005N-
0345) is attributable to the Majority side of the Subcommittee on Criminal Justice, Drug Policy and
Human Resources only.
Comment Number EC16770 addressing "Drug Approvals: Circumstances Under Which an Active
Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-
Counter Drug Product," cannot be attributed to the minority members of the subcommittee.
Please amend the comment by attaching this letter, and/or the following addendum:
<14: 6.5.4>The comment expresses the view that allowing the marketing of the same drug in the same
packaging as both prescription and over-the-counter is bad public policy and potentially illegal; using age
as the sole criterion for determining whether a drug may be purchased over-the-counter or by prescription
only is arbitrary and dangerous. The views of the majority side of the Subcommittee are reflected in this
comment. This comment may not reflect the view of the minority.
Thank you for your attention to this matter, and for allowing the Subcommittee to clarify attribution of the
comment. Should you have any questions, please contact Michelle Gress of the Subcommittee Staff at
202-225-2577.
Sincerely,
Mark E. Souder
Chairman
Subcommittee on Criminal Justice,
Policy and Human Resources
Government Reform Committe
COMMENT NUMBER - 2005N-0345-EC168
2005N-0345-EC168 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hein, Rachel
2005N-0345-EC168 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.8.5>no...drugs cleared for OTC usage should not have additional restraints of prescription
requirements based on age. But instead should have clearly labeled information for dosage and dangers,
especially when applied to minors.
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1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
no...drugs cleared for OTC usage should not have additional restraints of prescription requirements based
on age. But instead should have clearly labeled information for dosage and dangers, especially when
applied to minors.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>yes...why are you holding up the release of a scientifically approved drug for prescription
requirements that would lend the drug ineffective?
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>no...please follow previous rulemaking precedents and release the drug for use.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2>The FDA should not limit the sale of an OTC product to a particular subpopulation.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2, 7.3.1.2>It should NOT. Clear instructions and warnings should instead be required of the drug
distributor.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 3.7.1>It is illegal to withhold OTC suitable active ingregients based on discrimination by age, gender
or race. All packaging should contain full information.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.1>Only if there is a proven danger of bodily harm to the actual user.
GENERAL
GENERAL
<8: 1.2.3>If the FDA has found this drug (Plan B) to be scientifically safe for OTC use, then it should be
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released as such. No additional delay or politically motivated restrictions should be applied.
COMMENT NUMBER - 2005N-0345-EC170
2005N-0345-EC170 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Babb, Beverly
2005N-0345-EC170 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
Please read answer 2B
2
B. If it could, would it be able to do so as practical matter and, if so, how?
<1: 1.2.1, 7.4.4, 7.4.6>On the front of the package thelabel could read, "Prescribed for women over the
age of 16". On the bar code put a line that "bings" when going thru the cash register line and alerts cashier
to ask for ID. You need to acknowledge that kids get "adults" to buy them beer and young women under
16 will get older friends to do the same thing for Plan B.
Face reality and put it on OTC. Stop the obstruction and put it out there for use. This is from a
Grandmother with daughters and granddaughters. Use common sense. Thanks for
the opportunity to have a say. Beverly Babb
COMMENT NUMBER - 2005N-0345-EC171
2005N-0345-EC171 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Pinkerton, Mike
2005N-0345-EC171 - TEXT
1
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.8.5>No. I believe that the interpretation is overly restrictive and ignores situations such as this
(appropriate for a sub-population)and should not be codified. Case by case determination is more
appropriate.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.2, 3.8.8>No. The interpretation is too restrictive
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1, 4.4.2>Affirmitive, you seem quite confused between your role in approving drugs on scientific
merit and benefit (vs social engineering and backdoor legisalated morality).
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.2, 6.5.1>No. A reminder to the FDA that its role is to approve or dissapprove drugs for use based on
potential harm and validity of claims is needed.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.6.1, 6.6.3>Not relevant. Other such enforcement is already performed: alcohol, tobacco,
pseudopherine, spray paints and other inhalable solvents, ...
B. If it could, would it be able to do so as practical matter and, if so, how?
See answer to A above. Follow the existing models.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.5>Differentiation should only be required if it can facilitate enforcement.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 8.5>When the package differentiation is necessary as part of enforcement procedure.
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GENERAL
GENERAL
<8: 1.2.1>I do not believe that this should be restricted for any age group. I believe that this is a necessary
part of giving underage pregnant females a chance to prevent unintended pregnancy. With the explosion
of unwanted pregnancy in females under 16 anything that allows them to address the mistake is a positive
step. Young females will not tell parents or doctors, but will try this if its available. Requiring a doctor or
parent will simply make this inaccessible.The staggering statistics regarding the impacts of inintended
teen pregnancy on society as a whole include the continuation of the cycle of poverty/lack of
education/low income/crime that many unintended births feed. How moral is that?
COMMENT NUMBER - 2005N-0345-EC172
2005N-0345-EC172 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ross, Angela
2005N-0345-EC172 - TEXT
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 6.1, 6.6.3, 7.4.4>Absolutely. In the same way that alcohol and tobacco are perfectly legal to one
population (those over the age of 21 and 18, respectively) and enforceably illegal to a subpopulation
(those underage), it would be enforceable to limit sales of an FDA-approved product. It would absolutely
not be enforceable to limit sales to a subpopulation based on almost anything other than age, however, as
age is easily determined by simple identification.
B. If it could, would it be able to do so as practical matter and, if so, how?
<2: 7.4.4, 7.4.6>It seems to me that this would be entirely practical. Again, in the same way that a person
selling tobacco or alcohol is required to check identification of the purchaser, a pharmacist would have
this same requirement. Additionally, birth date is a matter of medical record and would either be in a
pharmacist's file already or can be requested as an identification tool. Over-the-counter has come to mean
different things in this day and age. At present, we do not have to interact with a pharmacist for all of our
medical needs. As Commissioner Crawford stated, most cough syrups, pain killers, flu remedies, etc., are
just on shelves outside of the pharmacist's counter. However, there are also certain OTC medications that
are kept in locked cabnets or behind the counter. While they do not require a prescription, a person has to
request them from pharmacy personnel. It would be easy to keep an OTC product behind the counter and
to request identification from anyone asking for the product -- not as a matter of record but for the
purposes of determining age.
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3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<3: 9.2.1, 9.2.2>Assuming that the package has the same instructions for use both OTC and by
prescription, I see no problem with selling the same product in the same package. However, if there are
different usage instructions depending on whether the product is OTC or by prescription, a separate
packaging would be important.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<4: 9.2.2>As I stated above, if the product requires different usage instructions based only on whether it
is sold OTC or by prescription, it may be inappropriate to use the same package.
GENERAL
GENERAL
<5: 1.2.1>The real question in all of this seems to be "What is the danger in the subpopulation getting
ahold of this particular OTC product?" In the case of emergency contraception, marketed as Plan B, most
if not all of the scientific research has indicated little to no risk to any population. Also, in this case there
are so few pills sold at once (i.e. it is a one-dose package, in my understanding) that an overdose is highly
unlikely. Additionally, the risks for abuse, overuse, or addiction are slim to none. So what is the real
purpose of limiting the sale? One possibility is lack of scientific research on the effects of emergency
contraception on women below a certain age. Another possibility is the belief of our society that people
under a certain age are unable to make sound and reasonable choices about their own lives, including their
own health care (e.g. age of consent laws, drinking/smoking age laws, driving age laws). These are both
sound explanations for limiting activities. In addition, the examples I provided are examples wherein
performing these activities (driving, drinking, smoking, etc.) before a certain maturity level is reached
could cause a danger to oneself or another. So, is there a serious danger to selling emergency
contraception to a 15-year-old or even a 13-year-old woman that is not present when selling emergency
contraception to a 17-year-old woman? Regardless of the answer, no one is asking for the drug to be
available to women under the age of 16. While I understand the need for consistency in approving
medications and also what it means to set a precedent, this type of drug is unprecedented and the FDA
needs to create a healthy policy accordingly. If this society is serious about women's health care, about
reducing the number of unwanted children, and about decreasing the number of abortions, emergency
contraception needs to be easily available to all women of reproductive age.
COMMENT NUMBER - 2005N-0345-EC176
2005N-0345-EC176 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Murphy, Cynthia
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2005N-0345-EC176 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
This is a completely insignificant question.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.2>No.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 3.2>n/a The last thing we need in this country is MORE rules!
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1>Yes, but why would it want to.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 6.1, 6.3.5, 6.6.3>Yes, this should be obvious as there are several products sold at market that the sales
of which are restricted only by age. (alcohol, cigarettes, alieve-neproxin)
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1>of course.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
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<7: 9.2.2>none.
GENERAL
GENERAL
<8: 1.2.1>Birth control is a personal issue and women should be free - AT ANY AGE - to deal with it
however they choose to. <9: 2.1>Quit fiddle-farting around and approve it already.
<10: 1.2.1>Allow women the same sexual freedom - AT ALL AGES - as men have!!! It is long overdue!
COMMENT NUMBER - 2005N-0345-EC181
2005N-0345-EC181 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Steward, Linda
2005N-0345-EC181 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>no. It should be one or the other,not both.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.2>no.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>no.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.2>no.
2
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A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.1, 6.3.5>yes. Laws would be made to make sure of that.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 6.6.1, 7.1>yes. The states would regulate it.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1>yes.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.2.2>None.
GENERAL
GENERAL
<9: 6.6.1, 7.4.4>A drug is either safe for over the counter sale or it isn't. I now have to buy my otc sinus
pills at the pharmacy and sign for them. The same thing could be done in this case. ID could be required
also.
COMMENT NUMBER - 2005N-0345-EC186
2005N-0345-EC186 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Wilson, Rhianna
2005N-0345-EC186 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.9.1>Yes. There are already other laws and rules involved in the process of purchasing OTC
medications. Such as only being allowed to purchase so many packages of sudafed etc. So inflicting
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another law on societies consumers will not come as a shock. Especcially dealing with a medication that
carries so much of an importance to release because of its immeditate window of effectivness.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.2, 6.5.4>No, the gaurdians and parents of that subpopulation should be able to purchase the
medication for the subpopulation.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<3: 1.2, 8.1>Yes. There should be more information about Plan B on the FDA website and should be
readily available to all consumers.
GENERAL
GENERAL
<4: 1.2.1>I believe that it is very important that Plan B is available OTC. Specifically becuase it needs to
be taken within such an immediate window period in order to be effective. The packaging of Plan B
should have more information about the product Plan B, including all known side effects and precautions.
Help lines and websites with further information should be included. Teenagers under 16 should still be
able to recieve the medication through prescription.
COMMENT NUMBER - 2005N-0345-EC1927
2005N-0345-EC1927 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Moon, Kristin
2005N-0345-EC1927 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
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<1: 3.1, 3.8.3>Yes--often patients will abuse the OTC product--that is--to take it incorrectly and do
themselves harm--even when the package is labeled for safe use. Other times, patients need doctor contact
to rule out severe illnesses or needs, but having the medication available OTC keeps them out of the
doctor's office
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 7.5.3>If the drug is available AT ALL in OTC, the subpopulation will have a much easier time of
getting the drug--and if they want it, they WILL find a method to get the drug. The FDA would have a
very difficult time enforcing such a law. Better to leave the item in RX status.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.6.4>It should not be legal to sell the items in the same packaging--the average consumer would
have too easy a time of calculating what was necessary for a prescription dosing of the drug.
GENERAL
GENERAL
<5: 1.2.3>I would strongly urge the FDA to not permit the OTC sale of the 'PLAN-B' type oral
contraceptive--the so called morning after tablet. Women should be checked by their physician (i.e. need
to get a prescription for this drug) so that:
1)Sexually transmitted disease can be detected and
2) Statutory rape or sexual abuse can be guarded against
COMMENT NUMBER - 2005N-0345-EC193
2005N-0345-EC193 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Witherwax, Carol
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2005N-0345-EC193 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.3>When the product would help to benefit the majority of the people (in this case women) and
assist in aleviating the unneccessary medical, social, and psycological impact on society if the drug was
not dispensed.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 7.4.4, 7.5.3>Probably not 100%. Pharmacies can be mandated by law to request thatcustomers show
photo ID, but as we all know IDs are very easy to forge. A person age 16 could or could not look their
age. It would be difficult.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<3: 8.2>I think that the packaging should be different (maybe just in color) so that the prescription drug is
more distinquishable from the OTC product.
COMMENT NUMBER - 2005N-0345-EC194
2005N-0345-EC194 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Morrisroe, Julia
2005N-0345-EC194 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
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<1: 3.9.1>There are many otc drugs available that are not suitable for children...but here were talking
about girls....under 16. Clairitn for adults vs. clairitin for children. We rely on individuals to make the
right decision. The FDA is supposed to check on the safety of the drug, not police individual usage,
because if individual usage were the issue the FDA has failed miserably....valium for example.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.3.4>The confusion relates to the FDA unwillingness to move forward on this particular drug, had
the FDA's action been consistently obstructionist about Viagra and access to Viagra, you'd be in a better
position to defend this case.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.5>If you rule that access is a right for all women.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 7.4.1>We're able to sell cigarettes behind the counter, many drug stores sell condoms behind the
counter, or pornography for that matter. Why this is a problem for the FDA I do not know.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2>No, keep you hands off. Your talking about individual rights here, the agency is stepping out of
bounds.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1>Yes, again this seems like your making problems in order to avoid making a decision on this
drug.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.2.2>None, see above
GENERAL
GENERAL
<8: 2.1>I am so deeply offended that the FDA has become a politicized agency. Your rulings are no
longer trustworthy, your decision making ignores science in favor of political position, because of the
agencies inability to fulfill it's mission you should disband the agency. You've become a waster and
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abuser of taxpayer money, and I thought your job was to investigate the effectiveness and safety of drugs.
COMMENT NUMBER - 2005N-0345-EC195
2005N-0345-EC195 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dowell, Duane
2005N-0345-EC195 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>there is no compelling reason to initiate the process at this time
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Same as "A" above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>There seems to be confusion at the FDA.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>That is not likely.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 7.5.4>It seems that it would be overly cumbersome for the pharmacist.
B. If it could, would it be able to do so as practical matter and, if so, how?
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<5: 6.6.4>There is some precedent in control of firearms and of narcotics.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
Yes
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 3.4, 9.2.2>None
GENERAL
GENERAL
<7: 1.2.1>In the case of the drug, Plan B, the science is clear that it is safe and effective. It is also clear
that prompt and easy access is important for ALL women of childbearing age.
COMMENT NUMBER - 2005N-0345-EC196
2005N-0345-EC196 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hibberd, Rachel
2005N-0345-EC196 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.11>This is a non-issue, as you are well aware, Mr. Crawford. First of all, there is no reasonable
objection to marketing a product as simultaneously OTC and prescription. The only problem this type of
marketing is likely to cause is confusion in the public as to why a woman of 16 and a woman of 17 must
go through different processes in order to have access to adequate contraceptive care. The confusion will
be justfified, because the Not Approvable letter issued to Barr regarding the drug's not being safe for
women under 17 was just one of a series of politically motivated and completely irresponsible moves
taken by you, against the wishes of the FDA's scientific advisory panel.
1.
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
See above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1, 4.3.4>Yes, it makes no sense from a public health standpoint. Women are not served by this kind
of maneuvering; if this agency were really interested in protecting women's health, they would allow
women access to this needed drug.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>No. <4: 5.4.2.2>The majority of the public is not familiar enough with the facets of the
FDA's bureaucracy to understand even the questions on this "public" comment form.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 7.1, 7.4.4>YES, this again is a rediculous question. The ruling would be enforced in the same way all
other age-controlled substances are enforced: the vendor will simply ask the consumer for ID proof of
age.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 6.6.3>Asking this question makes the FDA look rediculous from a public perspective. Everyone is
familiar with the processes in place to keep minors from purchasing, for example, tobacco products and
alcohol. While these enforcement efforts may not be perfect, it must be admitted that allowing a 15 year
old to prevent an unwanted pregnancy poses less of a public health risk than allowing an underage person
to consume tobacco products.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1>Why not? Again, a question that is absurd and reinforces women's belief that the FDA is not
being honest with the public regarding its reasons for blocking Plan B.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
Can you think of any?
GENERAL
GENERAL
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<8: 1.2.1, 2.1>Mr. Crawford, I cannot express the level of frustration and bitterness that I and every
woman I know is experiencing over your latest decision. We feel that we are being grossly
misrepresented, as you pander to a small minority opinion based on erroneous medical data (the anti-
choice groups who insist that Plan B is an "abortion pill.") Please take a moment to consider the profound
impact your decision is having on women in vulnerable situations, ESPECIALLY the nation's most
disenfranchised women: young women, poor women, women without an adequate support network.
Imagine a teenaged girl who comes from an abusive, unsafe environment. She is more likely to
experience unplanned pregnancy, because she is less educated and suffers from behavioral problems
related to her family instability. She is financially unable to go see a doctor, she has no car to get to a
doctor's appointment, she is unclear on what her options are regarding confidentiality, and she cannot turn
to her family for help. She does not want to have a child. Under the current system, her options are to give
birth or have an abortion. By allowing Plan B to be sold over the counter, we can give countless women
in similar situations a "second chance."
COMMENT NUMBER - 2005N-0345-EC1970
2005N-0345-EC1970 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Crousey, Joshua
2005N-0345-EC1970 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.2, 6.5.4>No, as a law student I can say that there would be significant limitations. This would be
regarded as creating a 'class' of people. This always has problems associated with it.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.5.3>Here's my biggest problem. If it's available easily, what's going to stop an older person from
buying it when he finds out that he got an underage girl pregnant? Right now, we have the prescription
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process in place and serious consequences for trying to avoid using a prescription. This is a drug that we
just might want people to have to get a prescription.
How would you be able to tell who should or shouldn't receive it? Are you going to check ids at the store?
How can we be sure that older people won't give it to younger people?
COMMENT NUMBER - 2005N-0345-EC199
2005N-0345-EC199 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Gay, Sarah
2005N-0345-EC199 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
Maybe- see below.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
This is the same question as above, except with a typo.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<1: 1.2.1>There is significant confusion as to why FDA is making such a huge deal of its interpretation in
this single case, which has such important ramifications for women, and whose drug has been demanded
as OTC-available in the U.S. for years, by both doctors and the public. There is also confusion as to why
the application for the combined status (Rx and OTC) was framed in terms of age in the first place,
instead of requesting simply to make it OTC across the board. Did the applying agency craft its request in
terms of age, based on FDA agency findings (such as those quoted below)?
C. If so, would a rulemaking on this issue help dispet that confusion?
<2: 5.5>Yes and No. If FDA Rules are based on scientific recommendations, rather than political
pressure, the current application to make 'Plan B' available OTC to women 17 and over is consistent with
the FDA Commissioner's own statement that 'The FDA?s drug center, the Center for Drug Evaluation and
Research or CDER, completed its review of this application, as amended, and has concluded that the
available scientific data are sufficient to support the safe use of Plan B as an over the counter product, but
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only for women who are 17 years of age and older,' and the drug application should be approved. A
rulemaking on the issue of general interpretation of section 503(b) is irrelevant in this case.
<3: 6.3.4>IF it's a medical concern, based on research, that age affects how the drug is received by the
body, and that the drug will affect younger women differently BIOLOGICALLY AND MEDICALLY,
the supporting science is there, and the drug should be allowed to go to market as proposed, based on
earlier precedents establishing different medical indications and effects for such an allowance. If it is
NOT a medically-based distinction, and sound scientific research (free from political framing) shows it is
safe for any woman regardless of age, the drug's availability OTC for anyone should be approved as has
been consistently recommended by FDA scientists, doctors worldwide, and by the public who wishes to
exert control over their reproductive health.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.3.5>As a matter of law, it's a moot point; if the FDA passes such a regulation, it is already law, no?
Isn't the FDA granted law enforcement powers related to its regulations?
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 6.6.3, 7.3.2>I don't know, that is a question for YOU to deal with! What does FDA enforce now?
Why should it be any more difficult for the FDA to enforce this than any other prescription-only
regulations?
<6: 7.4.4>OK, you've got a supply available to the larger population OTC. Why couldn't, for example,
age-i.d. requirements such as those governing sales of cigarettes and alcohol be enforced at the sales
counter, and become the responsibility of general law-enforcement, while regulation of the prescription
sales remains purvue of the FDA?
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1>I frankly don't see why this is an issue. Yes.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.2.2>None.
GENERAL
GENERAL
<9: 1.2.1, 2.1>The reversal of the FDA's promise to make a decision on this application by September, is
disappointing in the least and quite frankly, a bit sickening. It appears quite political and is a sad state of
affairs. Your statement of August 26, 2005 reads as a transparent stalling tactic, devoid of solid scientific
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foundation and based on thinly devised 'concerns for long-term policy implications.' I fear for the
integrity of the agency. While genetic engineering has been introduced and encouraged by the FDA for
major industry growth over the past ten years, with no assurance I know of that long-term implications are
non-existent, I recall no such waffling on considerations about or calls for further research on it. We now
have fish genes in our corn with no real knowledge of how this will affect our immune systems and gene
pools over generations; yet you are so 'concerned' about the implications of a proven, safe way for women
to take their own health and reproductive decisions into their own hands, you would limit that ability for
another span of years. This behavior is inconsistent with an interest in the public health and is deplorable
on the part of the FDA. I urge you to change your direction and allow the resolution that has been
recommended by responsible scientists and experts for two years: get the drug to market and available
over the counter, whether to those only over 17 or to all. You don't need the public's input on how to do
that. That is your area of expertise. You already have the public's mandate that it be done.
COMMENT NUMBER - 2005N-0345-EC2009
2005N-0345-EC2009 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Gibbons, Bridget
2005N-0345-EC2009 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes. <2: 3.8.1, 3.9.1>The FDA already does this for nicotine replacement drugs, and in
the interest of legislative clarity, a clear rule should be established for drugs available in both prescription
and OTC. This will finally allow the FDA to make a decision regarding Plan B, a decision consumers
have waited on for years.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<3: 3.1>Yes. <4: 3.8.1>Such a rule will clarify this rule for future drugs so that consumers will
have easier access to drugs. As the pharmaceutical industry becomes more and more involved in the
everyday lives of Americans, increasing ease and access will aid both industry and consumers in making
the right drug choices free from the need for prescriptions for drugs determined to be safe for OTC by the
FDA.
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B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<5: 4.2>I disagree that there is confusion over this issue. <6: 5.3.2>I believe that the confusion
surrounding Plan B stems from religious and political disagreement with the drug itself. However, if a
clarification of the rule will allow the FDA to finally make a decision regarding Plan B, I would approve
of a rulemaking in order to facilitate decisionmaking.
C. If so, would a rulemaking on this issue help dispet that confusion?
<7: 5.3.2>As stated above, I think the "confusion" is merely a political smokescreen. However, future
drugs may cause legitimate confusion, so perhaps it is in the best interest of the consumer population to
have a bright-line rule regarding these drugs.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<8: 6.1>Absolutely. <9: 6.4.1>Although I personally disagree that there should be an age limit
on access to Plan B, there are already age limitations on other drugs like Nicoderm and Nicorette. <10: 6.6.2>As a matter of public policy, it is up to the legislature to determine age limits, as the
FDA commission has tried to do, despite interference from outside sources.
B. If it could, would it be able to do so as practical matter and, if so, how?
<11: 6.4.1, 7.4.4>The FDA already only allows nictoine drugs to be dispensed to those over 18. Adults
present an ID to get their product. Any other drug could be enforced in the same manner.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<12: 8.4.1, 9.1.1>Yes. There is no reason to make arbitrary distinctions in packaging as long as the
content of the drug is the same. As long as the products are substantially the same product, with no
difference in content or dosage, there is no reason to require different packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<13: 9.1.1>If the products differed in dosage or content, it would be inappropriate to sell them in a single
package.
GENERAL
GENERAL
<14: 1.2, 2>The delay in approving Plan B is a political smokescreen. The deception on the part of certain
staff members at the FDA goes against the agreement reached with Senators Clinton and Murray this past
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summer. Either approve or deny this product. Follow your own policy. Remain independent and act in the
best interest of the population. Please.
COMMENT NUMBER - 2005N-0345-EC201
2005N-0345-EC201 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Tuchinsky, Marla
2005N-0345-EC201 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.3>To the extent that your interpretation is preventing women from getting access to a
perfectly safe and effective drug, yes.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.6.3>1. You already do limit the use of certain drugs by age -- alcohol and tobacco are both age-
regulated drugs.
<3: 6.6.1, 7.4.1>2. Drugstores routinely keep OTC products behind the counter (albeit usually to prevent
theft).
3. Several states have imposed limits on purchasing Sudafed, for example. Clearly, this should not pose a
stumbling block to releasing Plan B.
B. If it could, would it be able to do so as practical matter and, if so, how?
See my reply above.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.4.1>Why not, if the reason that one is prescription and the other not is based on the age of the
patient and not the drug itself? As I understand it, the product isn't different.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
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inappropriate to do so?
<5: 9.1.1>If the dosage were different. If they were manufactured by different companies.
GENERAL
GENERAL
<6: 1.2.1>It seems against your core mission to keep a safe and effective pharmaceutical off the market.
Denying women access to Plan B several years after it passed your scientific screens is inexplicable.
COMMENT NUMBER - 2005N-0345-EC2022
2005N-0345-EC2022 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Munro, Margaret
2005N-0345-EC2022 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No - the FDA should not initiate rulemaking.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.2>No - the FDA should not initiate a rulemaking to codify its interpretation.
GENERAL
GENERAL
<3: 6.5.1, 6.6.2>It is not the FDA's job to create public policy, merely to judge on the safety and efficacy
of pharmaceuticals, and to keep the food supply safe. Rulemaking may be effective in cases where
dosages need to be monitored in order to keep a pharmaceutical safe and effective - beyond that question,
the FDA should not be creating rules; if action is needed to keep a pharmaceutical from a certain group of
people, let Congress create and pass that legislation, and let them bear the responsibility of their actions.
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COMMENT NUMBER - 2005N-0345-EC206
2005N-0345-EC206 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Levy, Gayle
2005N-0345-EC206 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.9.1>This same situation has worked for Claritin. It is now available OTC and by prescription.
No other law making is necessary.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Same answer as above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>It would seem so. <3: 4.3.4>Apparently when allergy medication is involved and not a
political controversy, the FDA has no problem letting the medication go OTC. However, despite medical
and health officials deeming Plan B safe, the FDA has a problem with interepretion for political
gains.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.2>No. No amount of rulemaking (barring the overturn of Roe v. Wade) will change the politics
involved.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
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<5: 6.1>Yes. <6: 6.6.3>The government does it for both cigarettes and alcohol. Are you
planning to make both illegal to everyone because the age limitations cannot be 100% enforced?
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 7.1, 7.4.4>The same as they do for tobacco and alcohol. When someone comes to the register to buy
that product they will be asked for proof of age.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 8.8>I'm not sure how Claritin does it. You could look to that as a model.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<9: 9.2.2>I can't think of any.
GENERAL
GENERAL
<10: 1.2.1>This product has been safely used all over the world. The medical and professional staff at the
FDA have overwhelmingly approved it safe for OTC use in the US. There should be no reason why this
should be stopped. <11: 6.6.3, 7.4.4>The age concern can be alleviated the same way the
government does it for buying tobacco and alcohol. The person buying the medication can be asked for
age identification. <12: 2.1>Once Barr Labs proves it safe for those under 16 this
should not be an issue at all.
One of the reasons that the US is a great country is that we have political and religious freedoms,
however, these should not be intertwined. The thoughts of conservative Christians should not be ruling
how the FDA approves it MEDICAL products. The MEDCIAL experts have deemed this product safe
and that is the advice you should follow. Although the administration and the country seems to be
following a conservative bent right now, the FDA does not need to bend to religious pressures. I am a
scientist and am very dishartened that the FDA will not respect the views and opinions of their own
medical and scientific staff.
COMMENT NUMBER - 2005N-0345-EC21
2005N-0345-EC21 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Richman, Bobbi
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2005N-0345-EC21 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>DEFINATELY NOT. <2: 1.2.3, 3.3>IF IT WERE SAFE ENOUGH FOR OTC SALES
IT WOULDN'T NEED TO BE PRESCRIPTION. THE PUBLIC IS NOT KNOWLEDGEABLE
ENOUGH TO KNOW WHEN DR. SUPERVISION IS NECESSARY OR NOT. <3:
1.2.3, 7.5.3>THERE COULD BE NO MORE CONTROL OVER WHO BUYS IT OTC THAN THERE
IS FOR CIGARETTES OR LIQUOR. IF THERE IS AN AGE LIMIT, IT IS EASY TO HAVE
SOMEONE ELSE PURCHASE IT FOR THE PERSON. NOT ALL STORES INFORCE THE AGE
CRITERIA, NOR CAN THEY ADVISE CUSTOMERS WHETHER THEY SHOULD CONSULT A
PHYSICIAN.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<4: 4.3.4>IT IS THE MOST POORLY WRITTEN LETTER I HAVE READ. REDUNDANT, POORLY
EXPLAINED WITH NO INFORMATION ABOUT PLAN B FOR THE READER. TOTALLY
CONFUSING TO UNDERSTAND THE POINT BEING MADE
C. If so, would a rulemaking on this issue help dispet that confusion?
FIRST OF ALL WHOEVER WROTE THIS QUESTION "C" SHOULD HAVE PROOF READ IT.
WHAT DOES DISPET MEAN? <5: 1.3, 5.4.2.2>IF YOU ARE ASKING THE PUBLICS OPINION,
AND WE FEEL THERE IS CONFUSION, WHY DO YOU THINK IT WOULD BE ANY CLEARER
IF YOU MAKE A DECISION YOURSELVES. WE ALL KNOW THE CORRUPTI0N IN THE FDA IN
FAVOR OF MONEY MAKING DRUG COMPANIES SO WHY ASK OUR OPINION. YOU WILL
DO WHAT YOU WANT ANYWAY. LOOK AT VIOX. NO MORE TO BE SAID AFTER THAT.
COMMENT NUMBER - 2005N-0345-EC210
2005N-0345-EC210 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Felty, Amy
2005N-0345-EC210 - TEXT
Issue Areas/Comments
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1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
They could make it a law but I do not think they would be able to enforce it. <1: 7.5.3>At your local drug
store, who would have the responsibility of enforcing such limitations? The pharmacists are occupied
with their duties of providing the correct presciption medication and should not be required to
additionally 'police' who is buying what OTC drug and how old they are. The workers at the registers
should not be given the responsibility of contolling who buys what unless an entire system is set up as we
do for the purchasing of alcohol. <2: 7.2>Therefore, no I do not think it could be enforced in a
practical manner.
GENERAL
GENERAL
<3: 7.5.2, 7.5.3>As a quality assurance professional I would be concerned that it would not be practically
feasable to have the appropriate controls in place to prevent abuse of some drugs if they were sold as both
presciptions and OTC. Unless clinical studies covered things like misuse and over use of the drugs I
would be concerned for the safety of the public. We have to remember that the majority of the public are
not highly educated in the areas of science and would potentially not understand the negative affects of
the active ingedients if not used exactly per the label indications.
<4: 1.2.3>As a woman and a human being I am particlarlty concened with the effects of these presciption
vs. OTC discussions as it pertains to the Plan B drug. When the word got out of this drug being sold OTC
(provided that is what happened) I can forsee nothing but misuse of this drug by the majority of the
population. Either it would be taken too frequently as a substitute for the birth control pill or it would be
taken at incorrect times and could harm the development of a fetus.
Therefore, at this time I would disagree with making an active ingedient, used for the same indication,
available for use by both presciption and OTC.
COMMENT NUMBER - 2005N-0345-EC2107
2005N-0345-EC2107 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Oyen, Duane
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 218 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 210
2005N-0345-EC2107 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes. <2: 3.9.1>Please explain the effective difference between, for example, OTC
ibuprofen and Motrin 600 with regard to prescription enforcement. This is neither new nor "molecular
biochemistry" (a subject specific "rocket science" metaphor)
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<3: 2.1, 3.1>Yes- and in a realistic way, not as outlawing disguised as regulation.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1, 6.6.3>Society does it all the time with substances that are legal but limited to adults- cigarettes
and alcohol, for example; prescription items are easier to track than those products. <5:
6.7, 7.4.5>The enforcement in a free society is imperfect, as is enforcement of any law in a free society,
but there are balancing tests that can be applied- risk versus cost, probability of misuse, penalties for
fraudulent acquisition and use, etc. that will mitigate the problem.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.4.6, 7.6>The cutoff age should be 18, or 15 with parental approval- not 16. That means the parent
buys and signs for it, not a minor under any circumstances. <7: 7.4.1, 7.4.5, 7.4.6>Over
age 18, the person must ask at the pharmacy counter and sign a specific certification acknowledging that
it is illegal to pass the compounds on to anyone else, and the signature is an oath not to do so, under
significnat penalty of legal sanctions, including possible jail time.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 8.2>The different products should not be sold in the same packaging. <9: 8.6.4>There
should be signficant alert notices on the OTC package and the rules regarding consumer eligibility shoud
be broadly disseminated to enhance enforcement success.
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B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
N/A
GENERAL
GENERAL
<10: 6.5.1>As with all liberty versus regulation issues, in a free country there should be a presumption
that the public is not moronic, nor criminal, nor incapable of being responsible for his or her own life.
There are a lot of places where things should be culturally discouraged but not outlawed- and morality is
absolutely the first area to which that applies. We need the same campaigns against underage promiscuity
that we have against smoking, but that is not a reason to play Big Brother to adults.
If the only criterion for illegality is the possibility that a drug might be improperly dispensed second-
hand, we need to outlaw ALL pain medications, period.
<11: 6.5.4>But the parental rights to deal with minor children should not be curtailed under any
circumstances. There is a point where the family has to trump the culture, and the law should enable that.
COMMENT NUMBER - 2005N-0345-EC211
2005N-0345-EC211 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Young, Stan
2005N-0345-EC211 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
No.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
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<1: 3.2>No.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>No.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2, 6.5.3>No, this question has already been addressed in the case of parental notification laws, for
example. They linger for a little while, then are tossed out at appeals court level.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2>No. <6: 7.5.3>A teenage girl who feels the need for this medication will borrow an
older sister's ID, or use her fake ID, or get an older friend to get it, or heaven forbid, shop lift it. Of
course, a friendly pharmacist must might not ask the age question. And as an over the counter med for
some, I'm sure some enterprising soul will set up a website and offer it over the internet.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
Moot point.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
Moot point.
GENERAL
GENERAL
<7: 2.1, 3.8.7>As a conservative Republican, I'd note that the commissioners should not waste my money
trying to go down this twisty path of logic. You'll trip yourselves up, and cost the government and the
consumer money. <8: 1.2.1>The women who feel the need for this product need it
quickly, without jumping through regulatory hoops. It's not your job to protect their virginity - by
definition, that's gone anyhow. Contraception is legal, abortion is legal. If this drug is reasonably safe and
effective, approve it and get your noses out of these women's personal lives.
We're talking someone old enough to have sex, old enough to have a baby. I'd rather have a 12 year old
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buying and using this than having a 13 year old mother. Sticking your heads in the ground and saying
"don't have sex" is too late by the time we're talking this drug.
Let's make this the least traumatic we can on all concerned.
COMMENT NUMBER - 2005N-0345-EC212
2005N-0345-EC212 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kisly, Anne
2005N-0345-EC212 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.4>I think the text and examples provide clear examples of when a drug product may be marketed
as both prescription and OTC. Examples should not be interpreted to mean that they cover all situations.
They are after all, examples.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 3.8.5>The interpretation of it may be confusing because, as in the case in question, the safety data for
levonorgestrel is different from the safety data in the examples and the past regulatory decisions. I would
expect decisions regarding prescription(RX) and OTC access to be made on a case-by-case basis. Not all
drugs will fit the examples provided. The regulatory interpretation of section 503(b) will never explicitly
address all the different possible situations.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 3.8.5>I think a sentence could be added to clarify that decisions are made on a case-by-case basis. I
doubt that any rule is hard and fast and will cover all submissions.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 7.4.4>Someone would have to act in the role of the enforcer. In the case of the OTC availability of
levonorgestrel, the pharmacist would have to check the consumer?s age by asking for personal
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identification. The pharmacist would have to assume the person, if of legal age, is buying it for herself or
for someone who is of legal age. The assumption is the problem.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.5.3>No. I do not think it is practical. We know that minors have friends who are of legal age who
buy restricted items for them. The situation with levonorgestrel is no different. Consider the motivation
level of a young woman who does not want to handle an unwanted pregnancy. The motivation to acquire
and take emergency contraception (EC) would be high. While a licensed medical practitioner could still
prescribe and counsel the younger patient on the safe use of EC, I?m not convinced this is an absolute
necessity. If there are data, from a randomized controlled study, that show a younger woman is at risk if
her access to EC is not limited by prescription and she does not receive counseling, I would challenge the
extrapolation of the findings from the sample of study participants in the study to the population at large. I
expect a highly-motivated young woman would read and follow the instructions on an OTC product.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.3.4, 8.9>Do you mean the same products (not different in terms of strength, route of administration,
indication, etc) or the same package? Is less information required on an RX package because someone
assumes the licensed practitioner provides counseling, than an OTC package? The patient or consumer
information, regarding dosing instructions and safety risks provided in the package, should be the same
for a product available OTC or RX. An OTC package should list the following in large font size: (1)
specific situations in which levonorgestrel should NOT be used; (2) the side effects to be expected; (3)
information for special groups, possibly diabetics? The choice of words should be carefully selected, eg,
side effects not adverse events, specific situations in which levonorgestrel should NOT be used, not
contraindications.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.1>This must be determined on a case-by-case basis. All possible scenarios can?t be foreseen. As
soon as we agree, this circumstance or that circumstance requires different packages, another
circumstance will arise to be an exception.
GENERAL
GENERAL
The following information can be read easier in the attachment, where my response in italics follows the
FDA question or comment. The italic font doesn't show up below (at least not on this screen). I would
appreciate acknowledgement that this was received.
<8: 8.9>The question we have been asked to address is whether Plan B should be available without a
prescription on a pharmacy shelf, similar to the way other OTC medicines like some cough syrups and
allergy pills are sold, for women age 16 and older, and remain prescription-only for those under the age of
16.
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How severe are the side effects (nausea and vomiting) if taken incorrectly, enough to meet the criteria for
a serious adverse event, or are they mild, transient events that occur in isolation (without other events)?
Are the proposed dosing instructions in the package provided by the drug company clearly written, such
that counseling by a licensed practitioner is not necessary?
<9: 1.2.1>Can age be used as a criterion on which we decide whether a drug should be prescription or
OTC, as has been proposed in this case?
I would question if factors other than age comprise the real underlying basis for restricting access to a
medication. In the case of EC, age, in and of itself, is not a valid criterion for ethical reasons. I don?t think
the majority of women should have restricted access to EC, because a few women are at greater risk from
of a lack of understanding dosing requirements, dosing limitations, lack of understanding the potential
safety issues, etc.
In the case of levonorgestrel, the decision to restrict access by younger women sends a message to young
women that they can?t read and understand instructions on a package that describes dosing instructions,
safety warnings, etc. Limiting access to EC to younger women is not ethical and is discriminatory,
because it assumes low intellectual abilities and poor judgment on the part of the younger women.
My 12-year-old son, with his 7th grade education, can walk into a store, buy, and take aspirin or Tylenol
following the dosage chart on the bottle.
Am I supposed to be convinced that young women are less intelligent than he is in understanding how to
take an OTC drug?
<10: 1.2.1>The FDA?s drug center, the Center for Drug Evaluation and Research or CDER, completed its
review of this application, as amended, and has concluded that the available scientific data are sufficient
to support the safe use of Plan B as an over the counter product, but only for women who are 17 years of
age and older.
The decision to restrict access by younger women sends a message to young women that they can?t read
and understand instructions on a package that describes dosing instructions, safety warnings, etc.
I have a question for you. Is this really about concern for the safety of younger women, or is it about
preventing legal problems if young women acquire the drug OTC, take the drug incorrectly, develop
safety issues then sue the pharmaceutical company and accuse the FDA representatives of not doing their
jobs? A prescription is no guarantee that the patient received the necessary counseling from the licensed
practitioner on the specifics of how to use the medicine correctly, regardless of age. A prescription is no
guarantee that the patient will be compliant, regardless of age.
I commend you on your extensive safety review. Please continue. Since when was Congress staffed by
anyone who knows anything about evaluating the safety of drugs?
2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-
1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-
EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF 2005N-0345-EC212-Attach-1.PDF
COMMENT NUMBER - 2005N-0345-EC213
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 224 of 415
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2005N-0345-EC213 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Goggin, Terresa
2005N-0345-EC213 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.3.2, 3.8.4>No, I believe your previous guidelines are adequate. If it is safe without a
practitioner's prescription then it should be available OTC.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
See statement above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2, 4.4.2>I think the current guidelines are adequate and straightforward. Personal politics are what
is clouding the availability of this drug, and probably others in the future if this precedent is allowed.
C. If so, would a rulemaking on this issue help dispet that confusion?
See statement B.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 1.2.1, 6.5.4>OTC should not be limited; no more than we limit the sale of say aspirin, acetominaphin,
ibuprofen, cough syrups, decongestants, etc. Risk warnings...absolutely! Limited access...absolutely
not!
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 6.6.3, 7.1, 7.4.4>Certainly by prescriptions for minors and "carding" everyone else, just like alcohol
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or cigarettes...<5: 1.2.1>but the age limitation should not exist...if sex occurs
(consensual or non-consensual), even for a minor, quick access to the drug is essential to efficacy.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1>Yes, but this is just administrative wrangling...complicating things by trying to "please" a certain
political constituency.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.2.2>Under no circumstances would it be inappropriate; the drug is what it is...what is the point of
making the package a different color to show that someone is underage...other than discriminating against
them and singling them out for possible ridicule.
GENERAL
GENERAL
<8: 2.1>Let's get away from trying to satisfy a political base...the FDA was established to protect the
health of all Americans, not just one particular constituency.
COMMENT NUMBER - 2005N-0345-EC216
2005N-0345-EC216 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ellis, Pamela
2005N-0345-EC216 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
yes
1.
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.1>yes
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.1>Yes. <3: 8.8>Similarly to the current requirement of the statement 'Federal law requires
prescription for this medication' be printed on the Rx version and not on the OTC version. Although,
psuedoephedrine has recently been restricted to 18 and over and behind-the-counter status and it
underwent no package change whatsoever. Who is enforcing this limitation? This stall tactic is ridiculous
in light of the fact that these situations already exist in todays market.
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.1>Yes. <5: 6.6.1, 7.4.3>State Departments of Health will inspect the process as it does all
other processes. <6: 6.6.3, 7.4.4>ID's will be checked for OTC product as with nicotine
patches, alcohol, cigarettes, etc...<7: 1.2.1>However, let me be clear and say that Plan B
should be available OTC with NO age restriction. A bottle of Tylenol, which can be purchased by anyone,
poses a far greater health threat if used incorrectly than Plan B ever would.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 3.9.1>It is legal. For example, I currently have OTC Prilosec in my pharmacy AND a prescription-
only omeprazole. <9: 8.6.4>Therefore, Plan B would require different packaging on the
outside stating its Rx requirement for Rx version and not for the behind-the-counter version. The inside
packaging would remain the same as 15 year-olds will take it the same way as 30 year-olds will. <10: 2.1, 6.6.1>This is no reason for a delay to market. Incidently, pseudoephedrine products were
just put behind-the-counter, at least in my state, with NO change in packaging. Perhaps if pregnancy
affected everyone as does nasal congestion, years of delay and request for public comment would not be
necessary.
GENERAL
GENERAL
<11: 1.2.1, 3.3.3>Plan B is safe for use by women of ALL ages. It has been available OTC in over 38
other countries for years. The data is available on use in teenagers and adults and should have been
consulted at the time of application. Withholding this incredibly effective and safe drug, the 2
requirements for OTC status, the FDA is doing a disservice to women and women's healthcare and
destroying its reputation as a sound, scientific entity on which the American public can depend. <12: 1.2.1, 2.1>It should be clear to all, regardless of beliefs or values, that the effects of
taking Plan B is infinintely less damaging to the body than a pregnancy is. Especially when a 13 year-old
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is carrying to full term. When will women stopped being punished for their biology? Women must have
all the options possible to control their reproduction. This product is one of the best to come along in
some time. Stop bowing to right-wing political pressure and do the job the FDA was commissioned to do!
Be scientists and let individuals decide their morality.
COMMENT NUMBER - 2005N-0345-EC217
2005N-0345-EC217 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dietz, Ken
2005N-0345-EC217 - TEXT
GENERAL
<1: 1.2.1, 2.1>Your position on Plan B is clearly an attempt to delay approval of non-prescription sales
for some unstated reason. Your stated reason is full of holes, and is clearly unsupportable. <2: 6.1, 6.6.3, 6.6.4>The government currently has regulations in place requiring age-limited
availability for cigarettes, alcohol, firearms, pornography, and lotto tickets. But you can't establish a
similar regulation for Plan B?
I smell a rat here.
COMMENT NUMBER - 2005N-0345-EC22
2005N-0345-EC22 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rankis, A
2005N-0345-EC22 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
No, Current situation is fine
1.
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.2>No, Current situation is fine
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No, Current situation is fine
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>No, Current situation is fine
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2>No, the use of the product would be abused
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2, 7.5.3>No, the use of the product would be abused
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2>no
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.2.2>none
GENERAL
GENERAL
<8: 7.5.3>If a drug is indeed for "emergency contraception", there appears no way to control or enforce
it's use in emergencies only
COMMENT NUMBER - 2005N-0345-EC224
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2005N-0345-EC224 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Roettcher, Phil
2005N-0345-EC224 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.1, 6.3.2>I see no reason why a single molecule cannot be sold in two different formats though I
would prefer you follow the advice given by your medical staff that Plan B medications are safe for all
women of child bearing age. <2: 6.6.3, 7.3.1.1>Over the counter is fine, but if you must
compromise, treating it like tobacco, where there is a minimum age restriction would be fine. For those
under the age, a prescription should be obtained and dispensed by a licensed Pharmacy.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<3: 3.8.5>Decisions can be made on a case by case level.<4: 1.2.1> In the case of Plan B
medication, since the medication causes no harm by itself, it should be made widely available. Adult
women should be allowed to make decisions for themselves.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<5: 4.2>only by the FDA who are more politically bound!
C. If so, would a rulemaking on this issue help dispet that confusion?
<6: 5.5>Advance with the technology and society. Change the rules to allow for multiple applications of
the same molecule and let the market sort it out.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<7: 6.6.3>I don't really see enforcement as a legitimate issue for the FDA. The same folks who enforce
marihuana and vitamin supplement laws can enforce any unusual rules here. Personally, I don't think
there should be prescription restrictions here but if you must, enable the ATF to take on this task. Maybe
they can rename themselves DAFT.
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B. If it could, would it be able to do so as practical matter and, if so, how?
<8: 7.6>Does it really require law enforcement to make sure a young girl doesn't have an unwanted
pregnancy? Time is important with this drug. Restrictions only hurt society over time.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<9: 8.1, 8.9>Yes, unquestionably. The only people that would complain would be the pharmacy who can
mark up their product more than OTC.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<10: 9.2.2>None!
GENERAL
GENERAL
<11: 1.2.1, 2.1>As VP Dick Cheney said last year, "Freedom means Freedom." This product has proven
to be safe by all research and is not mind altering. Let women decide for themselves if they can stop an
unwanted pregnancy. Government should step as far away from this as they do nutritional supplements.
Make sure it is safe and effective for the public and let the public decide for themselves. If it is stupid, the
knowing user bears the consequences herself. Don't let fear and ignorance trump freedom for people to
make good and informed decisions for themselves.
COMMENT NUMBER - 2005N-0345-EC226
2005N-0345-EC226 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Cepeda, Baudi
2005N-0345-EC226 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
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when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
NO;
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.2>NO
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>NO
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>NO
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1>YES.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.4.4, 7.4.6>Last resort would be to ask those who look young to provide ID and to limit the sale to
just one package.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1>YES.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
N/A
GENERAL
GENERAL
<7: 2.1>Very disgusted that this decision is being based on political reason and not scientific. The FDAs
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mission is not being fulfilled when we have enough scientific data that ensures consumers that Plan B is
safe & effective and yet no decision is made. FDA needs only to act on data, not politics.
COMMENT NUMBER - 2005N-0345-EC23
2005N-0345-EC23 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Parks, C
2005N-0345-EC23 - TEXT
GENERAL
<1: 1.2.1>This drug should be sold over the counter, period. <2: 3.7.2>If there are health risks
to those younger than 16 or 17 years of age, they should be made very clear on the packaging of the drug.
There are many OTC drugs sold in dosages that are not supposed to be given to children under a certain
age, but the FDA has not initiated any special sales practices in order to regulate who buys those drugs.
The same practices that are applied to other OTC drugs should be applied to this one.
COMMENT NUMBER - 2005N-0345-EC2314
2005N-0345-EC2314 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: National Research Center for Women
2005N-0345-EC2314 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No, a rulemaking on Section 503(b) is unnecessary. <2: 3.3.2, 6.3.4>The FDA notes in
the ANPR that it has in numerous instances approved the dual marketing of an active ingredient for both
prescription and OTC use in just this manner. The differences noted by the FDA between these products
and Plan B (the age at which the user takes the medication and under what degree of medical supervision)
are all simply various conditions of use of the product, and are along the same lines as these other
differences in condition of use noted by the FDA.
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<3: 3.2, 3.3.2, 3.9.1>The supplemental application submitted at the request of the FDA presupposes a
meaningful difference in the conditions of use ? in this case, the comprehension levels ?between the two
populations. The FDA has concluded that users under 17 require a physician?s assistance, while users 17
and over can take the medication without that condition.
The dual marketing of Plan B to these respective populations defined by the FDA is permissible under
Section 503(b). Because the FDA has found that the product is safe for OTC users aged 17 and over, OTC
and prescription marketing of the same active ingredient is as appropriate with this drug as with any of the
others approved for both OTC and prescription use. The FDA has customarily approved drugs for
different conditions of use without requiring any statute, regulation, codification, formal or informal
guidance. While these administrative tools are often used by the FDA, they have not been deemed
necessary for the simultaneous marketing of an OTC and prescription product with identical active
ingredients and dosages.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No, a rulemaking on Section 503(b) is unnecessary. The FDA notes in the ANPR that it has in numerous
instances approved the dual marketing of an active ingredient for both prescription and OTC use in just
this manner. The differences noted by the FDA between these products and Plan B (the age at which the
user takes the medication and under what degree of medical supervision) are all simply various conditions
of use of the product, and are along the same lines as these other differences in condition of use noted by
the FDA.
The supplemental application submitted at the request of the FDA presupposes a meaningful difference in
the conditions of use ? in this case, the comprehension levels ?between the two populations. The FDA has
concluded that users under 17 require a physician?s assistance, while users 17 and over can take the
medication without that condition.
The dual marketing of Plan B to these respective populations defined by the FDA is permissible under
Section 503(b). Because the FDA has found that the product is safe for OTC users aged 17 and over, OTC
and prescription marketing of the same active ingredient is as appropriate with this drug as with any of the
others approved for both OTC and prescription use. The FDA has customarily approved drugs for
different conditions of use without requiring any statute, regulation, codification, formal or informal
guidance. While these administrative tools are often used by the FDA, they have not been deemed
necessary to effectuate the simultaneous marketing of an OTC and prescription product with identical
active ingredients and dosages.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<4: 4.2>No, there should be no confusion regarding the FDA?s interpretation of Section 503(b)(1).
<5: 4.4.1>Barr established, as required by the relevant regulations, that Plan B is safe and effective to
treat a condition that can be diagnosed by the patient. Furthermore, Barr established to the FDA?s
satisfaction that women could follow the directions for the medication that would render its self-
administration safe and effective.
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<6: 1.2.2>The FDA?s own advisory panel also overwhelmingly found that Plan B is safe and effective for
use by women of all ages. The FDA?s finding that there is insufficient evidence on the use of Plan B for
those under 17 presents no additional legal or practical concerns for its OTC use by women 17 and over.
<7: 6.1>The FDA has the legal authority to restrict an OTC product in this manner.
C. If so, would a rulemaking on this issue help dispet that confusion?
<8: 5.4.3>No, because there is no confusion.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<9: 6.1, 6.3.1, 6.4.1>The Office of Chief Counsel has previously determined that age restrictions for an
OTC product are legal, as in the case of Nicorette nicotine replacement therapy. Furthermore, there is no
indication that counsel was concerned that such a restriction would be unenforceable. A document
regarding the approval of Nicorette for OTC status states:
Furthermore, the OGC has provided us with a legal opinion that it is possible under the FC&C act to
impose restriction on the sale of the product to minors, if such restrictions are needed to ensure their
safety.
The FDA?s decision that it has the authority to restrict the sale of OTC products to minors in the case of
Nicorette applies with equal and full force to Plan B. While we disagree with the FDA?s view that Plan B
has not been proven safe for the restricted age cohort, FDA has, on advice of its own counsel, made
exactly the same kind of age distinction for Nicorette as it can make for Plan B in approving the drug for
OTC use.
B. If it could, would it be able to do so as practical matter and, if so, how?
<10: 7.4.2, 7.4.3>It is the professional responsibility and ethical duty of pharmacies and pharmacists to
abide by legally imposed restrictions on sales, such as age limitations. In the event that they do not do so,
state boards of pharmacies and others with authority to deal with issues of professional responsibility can
always step in, either directly or by notifying FDA.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<11: 8.1, 8.3.4>The products should be sold in the same packaging. Not only would it be legal to do so,
but it might be in violation of Section 502(a) to have different packaging if the drug works in the exact
same way for every user. Having different packaging for OTC and prescription users would convey to the
16-year-old user that she is in some way taking a different drug than her 22-year-old counterpart, which
would constitute misbranding under Section 502(a).
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
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inappropriate to do so?
<12: 9.2.1>No circumstance can be hypothesized where it would be inappropriate to sell the two products
in identical packaging so long as: (1) it is the identical drug; (2) it is identically labeled for each user of
the product; and (3) it has an identical method of action for each user of the product.
<13: 8.3.1, 8.4.1>OTC packaging is intended to be far more ?consumer friendly? than prescription
products. According to the FDA, ?the intended uses, directions and warnings [for OTC drugs] have to be
written so that consumers, including individuals with low reading comprehension, can understand them.?
While important information for a prescription product may be buried in a lengthy insert, OTC products
are required to have such information on the label. The current packaging for Plan B is appropriate for
both OTC and prescription users.
GENERAL
GENERAL
<14: 1.2.1, 3.2, 7.6>We strongly urge the FDA to abandon the proposed rulemaking, and to approve over-
the-counter availability of Plan B for women of all reproductive ages based on its impressive safety
record.
Greater access to this medication is likely to reduce the incidence of unintended pregnancy and abortion.
The pharmaceutical and retail industries are well-equipped to handle the approval of Plan B as an OTC
drug for those 17 and over, and as a prescription drug for those under 17. Thank you
for your careful consideration of these comments. If you have any questions please do not hesitate to
contact Diana Zuckerman, PhD at 202- 223-4000.
COMMENT NUMBER - 2005N-0345-EC24
2005N-0345-EC24 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Salvo, Aaron
2005N-0345-EC24 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.9.1>Currently there are several products that are available over the counter that are typically
categorized as controlled substances, but there are also similar prescription productions. For example
certain dosages of Ibuprofin are available by prescription only, but lower dosages can be purchased under
brand names such as Advil, and there is nothing stopping a consumer from taking a single dose of the
non-prescription strength product that would equal or even exceed the prescription dose. Also cigarettes
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are known to contain Nicotine, which is a narcotic, but Nicotine is now available as an OTC product in
forms such as Nicorette Gum. Neither of these products have caused the FDA any consternation.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Again, there are currently products that are available in an OTC and perscription form. So yes that FDA
should allow an active ingredient to be simultaneously marketed in both an OTC and prescription form.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.1, 6.6.3>The FDA has enforced the sale of certains drugs without the assistance of a perscription.
Once again alcholic beverages and cigarettes come to mind. A perscription is not needed for either
product, yet the FDA limited access to these products by people below a specific age. Even though
drinking ages are regulated by the states, there is at least precedence in law to keep a product out of the
hands of a certain sub-population.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.1>The practicality of enforcement would be difficult, but no more than existing products available
in both forms. As mentioned in previous questions a consumer may purchase an OTC Ibuprofin
and take a single dose that would equal the perscription strength. <4: 6.6.1, 6.6.3, 7.4.1>Recently,
however, certain states have take action to put certain OTC cold medications behind the phramacy
counter and only releasing them in certain quantities to people 18 or older. Putting both forms behind that
counter would allow an individual to get the required medication and put the oneous of enforcement on
the store to verify that it is legal to dispense the product. Again much in the same way that people are
"carded" for alcohol and tobacco products.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.1, 8.4.1>In short I see no reason why separate packages would be needed. A person who could not
legally purchase the product without a perscription would be stopped before leaving the store, unless they
had a perscription.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 9.2.2>I see no time that it would be inappropriate to sell the two products in a single package.
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COMMENT NUMBER - 2005N-0345-EC240
2005N-0345-EC240 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Cunningham, Wayne
2005N-0345-EC240 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.9.1>Yes, this is an issue that needs to be decided, and has certainly been resolved in areas
concerning controlled substances. It's not all that new or novel.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Apparently there is, since this question came up.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>Yes.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1>Yes. Other items have been regulated in a similar fashion.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 6.6.3, 7.1>It would be possible, just follow the examples set forth in how cigarettes and alcohol are
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regulated.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1, 8.4.1>They are the same product, so it would be unnecessary to have different packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.2.2>None.
COMMENT NUMBER - 2005N-0345-EC27
2005N-0345-EC27 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Pechacek, Deborah
2005N-0345-EC27 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.1>Yes I think the FDA needs to clarify this rule to eliminate any future issues.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.8.1>This definitely needs to be done to help Healthcare Professionals know when a product can be
sold as an OTC product and when it can not
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.3.2>Obviously there is since the Drug company is asking you to do something that I thought was
not legal.
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C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.1>YES!
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 7.5.3>I do not see how. In the case of "Plan B"; if you limit sales to 17 and older without a
prescription, what is to stop 13, 14, 15 and 16 year olds with "OLDER FRIENDS" from getting the
medication. The 17 year old "FRIEND" purchases it and gives it to the younger girls. Also you are
opening up a great BLACKMARKET industry for the product.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.5.3>Again - I am at a loss as to how you will control and monitor where the product goes, once it is
sold.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.2>NO - they need to be in 2 separate packages.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.1.2>ANY TIME
GENERAL
GENERAL
<9: 1.1>I think you are opening a major "can of worms" with this regulation. By allowing this to happen
with one drug, you are opening the door for ANY product to use this logic. All the manufacturer has to do
is show a reasonably safe side effect profile and then state that any adult is able to decide for themselves
whether they want the medicaiton or not. I think we havae already put too many unsafe products out in
the OTC catagory and do not need to add any more.
<10: 7.5.4>My other comment is about monitoring. How do you think you will prevent consumers in the
NON-EXEMPT catagory from purchasing and either giving or selling the medication to people in the
EXEMPT catagory? I see this as just a way for the drug manufacturers to shove their products out where
anyone can buy them. This will lead to irresponsible use of medications. If we are not concerned about
patient safety, the FDA might as well close down and let us buy everything in a local "DRUG STORE"...
Viva la Mexico
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COMMENT NUMBER - 2005N-0345-EC278
2005N-0345-EC278 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Endris, Kelle
2005N-0345-EC278 - TEXT
Issue Areas/Comments
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<1: 4.1>YES
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.1>Possibly.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.4.2>Through Public Health Clinics.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.2>NO!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<5: 9.1.2>Over the Counter
GENERAL
GENERAL
<6: 1.2.3>The Plan B emergency pill has the strong potential to end a conceived life. It should not be
accessible to any under aged person for a variety of reasons. A minor does not have the maturity or
understanding to know the long term impact of using such a drug. <7: 1.1>Also, no person,
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should be forced to sell a drug, chemical or substance if it goes against that individual's religious or
ethical beliefs. As a nurse, I would not assist with an abortion. A pharmacist should not be required to sell
the Plan B pill if it is against his personal belief system. Generating a law to require an individual to do so
negativley impacts that individual's constitutional rights. What are we becoming?
COMMENT NUMBER - 2005N-0345-EC281
2005N-0345-EC281 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: TomHon, Catherine
2005N-0345-EC281 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.1>This is purely dependent on whether this case represents an anomoly, which is not covered by
section 503b. If this is so, then the restriction of OTC status is arbitrary and not based on a scientific
basis. The question is whether one desires to leave future FDA drug approvals open to arbitrary
arguments or whether the scientific integrity and strength of those decisions should be preserved.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 1.2.2, 3.3.2, 7.3.1>I do not see that Plan B represents a unique case that in future should be used to
influence FDA activity and decisions. It may be difficult to argue that the population <16 years of age is
subject to greater harmful effect. But section 503b B, states that it (a prescription drug) is limited by
approved application under section 505.... One could argue that the "Prescription Drug" status is defined
by the limitations that must be spelled out in the approval of a drug application. It does not state that the
FDA is limited in its approval and must define an approved drug as only OTC or prescription. Therefore
it could allow the FDA via its official approval to designate the same drug as OTC and Prescription
dependent on different circumstances, in Plan B's case age.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1>In the particular case of emergency contraception - Plan B, yes. It is not clear why the FDA
believes this section falls short.
C. If so, would a rulemaking on this issue help dispet that confusion?
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<4: 5.2>No, the FDA can simply make transparent and concrete the basis for its decision.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.1, 6.3.5>Yes, it should be able to legally enforce the limitation. The FDA should also be able to act
against off-label drug use. But whether the FDA does undertake enforcement is another question. To
make this the deciding factor for approval means that the FDA should hold its legal ability to enforce, as a
standard to be met by all drugs up for approval. Given the rise in the number of prescriptions dispensed
for conditions for which the drug was never approved, this would swamp the FDA with enforcement
issues.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.3.2>In general, the FDA should be able to pursue punishments for all drug misuse by those
professionals who are in charge of controlling drug access. These multiple levels of control to drug access
include: Pharmaceutical industry, FDA approval, FDA approval only for specific conditions, MD
prescription, pharmacy dispensal.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1, 8.3.1, 8.4.1>Yes for the following reasons:
- the product is the same, no confusion as to content.
- simplification of inventory for the dispensing pharmacy
- Instructions for usage should include those for all ages and include any age-specific issues.
- within power of pharmacist to control or deny sale, at point of sale
With the control of OTC products which can be turned into Crystal Meth, we have a similar issue. The
access to the same active ingredient is controlled differently. One may be able to select it off the shelf in
one pharmacy chain but need to request it from the pharmacist in another. These drugs may also be in the
same package.
GENERAL
GENERAL
<8: 1.2>With the realization that this is a politically charged issue, I appreciate your wanting to cover all
the loopholes. In the end the FDA should strive for the solution, which supports its mission. The FDA is
responsible for protecting the public health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our nation?s food supply, cosmetics, and products
that emit radiation. The FDA is also responsible for advancing the public health by helping to speed
innovations that make medicines and foods more effective, safer, and more affordable; and helping the
public get the accurate, science-based information they need to use medicines and foods to improve their
health.
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COMMENT NUMBER - 2005N-0345-EC297
2005N-0345-EC297 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Levinson, R. Saul
2005N-0345-EC297 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.2, 3.1, 3.8.3>Yes, there are instances where a professional may prescribe a product when he has
contact with a patient, and instances where a drug product may be needed without prescribing
professional interaction. This is certainly the case with "Plan-B"... as it is an emergency contraceptive, the
user could be in a situation where there is no time for contact with a prescribing professional (weekends,
holidays, afterhours, etc.)... and needs immediate access to the drug.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
see above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No confusion.... just old fashioned politics are entering into FDAs interpretation of section 503(b)
of the act.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.3.2>Yes....especially since FDA's own advisory group, and the majority of the medical/scientific
community support the availability of Plan B as an OTC product and a prescription product.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
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<4: 6.6.1, 7.3.1.1>The product could be sold only by licensed pharmacists who could determine if the
requirements, if any, for OTC sale were met. Why is this so strange....FDA allows this with Category 4
and 5 controlled drugs, where allowed by individual State law.
B. If it could, would it be able to do so as practical matter and, if so, how?
Simple, see response above.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.1>YES
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 7.4.1>OTC product should not be sold to minors under the age of 16. Prescription product could be
sold to any bearer of a legitimate prescription.
COMMENT NUMBER - 2005N-0345-EC307
2005N-0345-EC307 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Wu, Jackie
2005N-0345-EC307 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
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Yes.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.1>Yes.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.1, 7.4.1, 7.4.6>In the case of Plan B, the subject needs to take the drug ASAP. The subject can buy
the drug without prescription but still through the pharmacist window. She should take the first pill under
the supervison of the pharmacist. An electronic pharmacy record will be helpful to track the number of
drugs a subject takes.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.6.4>Not critical. For practical manner, different package is easy to handle.
GENERAL
GENERAL
<5: 1.2.1>Plan B should be made accessible to those who have made the decision. If people decide that
they can not afford the risk of being pregnant, they should have a choice to prevent it happening.
COMMENT NUMBER - 2005N-0345-EC311
2005N-0345-EC311 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Waychoff, W. Aaron
2005N-0345-EC311 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
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<1: 3.1, 3.8.5>Yes - the FDA should understand that, just like many other substances in our society,
factors beyond simply the direct effectiveness and safety of the product on the human body must be taken
into account. Many medications currently available OTC effect persons of different ages differently and
carry labeling indicating such. In this labeling, use outside what is indicated by young persons is deferred
to a physician's recommendation. Similarly, drugs such a Plan B could be made available OTC and carry
labeling indicating that its use for women under 16 (or 17) is restricted to a physician's recommendation -
in the form of a prescription. Remember, a prescription is little more than an official recommendation by
a physician to use a particular medication at a particular dose.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes - the FDA should understand that, just like many other substances in our society, factors beyond
simply the direct effectiveness and safety of the product on the human body must be taken into account.
Many medications currently available OTC effect persons of different ages differently and carry labeling
indicating such. In this labeling, use outside what is indicated by young persons is deferred to a
physician's recommendation. Similarly, drugs such a Plan B could be made available OTC and carry
labeling indicating that its use for women under 16 (or 17) is restricted to a physician's recommendation -
in the form of a prescription. Remember, a prescription is little more than an official recommendation by
a physician to use a particular medication at a particular dose.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>The confusion is imagined on the part of the FDA. I belive that it is a trumped up excuse by
Lester Crawford to stall the approval of Plan B because it does not meet with his personal religious beliefs
and political aspirations.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.3.2>It would help as long as the rulemaking is not used simply to further delay needed medications
reaching the hands of those in need. The rulemaking *must not be religiously or politically
motivated*
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.3.5>As long as the subpopulation was not being discriminated against, and the limitation was in
place for demonstrable safety reasons, it should be able to enforce the limitation by law.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 6.6.3, 7.4.5>Just like with cigarette and alcohol sales, there will certainly be those in a restricted
subpopulation who will gain access to the drug. I do not belive that it will be necessary to enforce by law
such a limitation. However it would be important not to punish the member of a subpopulation who
obtains the product, but rather of the person(s) who enabled thier unlawful acquision of the product just as
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today the vendor or proxy is punished in underage cigarette and alcohol acquisition.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2, 8.6.2>I belive it should be packaged differently. A prescription form of the product should look
traditionally like a prescription medication due to the psychological impact it would make - particularly to
a subpopulation defined by young age. Since the reason for the restriction is to prevent misuse by young
women (in the case of Plan B) it should look like a "serious" drug to this group who obtains it via
prescription.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 8.2, 9.1.1>When there would be significant confusion as to the intended recipiant of the product - for
instance, if the same packaging was used for the non- prescription and prescription version (an idea I do
not support) then the prescription version, at a minimum, must be marked with the standard information
contained in a prescription label - name, directions, doctor, etc.
GENERAL
GENERAL
<8: 2.1>I firmly and completely belive that this issue is being brought up as nothing more than a stalling
tactic on the part of Lester Crawford. It is a shameful action and should result in the immediate expulsion
of the man from his position at the FDA. It has shaken the confidence in the organization at the worst
possible time. Lester Crawford is using his position to advance his own religious and personal beliefs and
political aspirations. Though I feel that a clarification in 503(b) would be beneficial, it should not be used
as a method for Lester Crawford to unilaterally impose his will on this country in direct opposition of all
the scientific evidence presented. He can no longer be trusted to remain in such a position.
COMMENT NUMBER - 2005N-0345-EC319
2005N-0345-EC319 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Myers, Micah
2005N-0345-EC319 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
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<1: 3.2, 3.8.8>There is no scientific or legal reason to have two packages containing the same drug at the
same dosage with one only available by prescription. That being said, there are moral and political
reasons to do so. Please do not engage in morality or politics.
2
B. If it could, would it be able to do so as practical matter and, if so, how?
<2: 1.2.1, 7.2, 7.5.3>Practically speaking, this is ludicrous. Girls or women who need the drug will get by
having a second source get it for them. And this is all right. Currently on the market is a potent
hallucinogenic called dextromethorphan. it can be bought by most anyone, but only adults should be
using the stuff really, because it has the capacity to seriously mess a kid up if too much is taken. Plan B
does not have this same capacity. It should be available OTC with no restriction the same as DXM. Please
ignore the politics of the issue and strictly make your ruling on the science.
GENERAL
GENERAL
<3: 1.2.1>Make the ruling on Plan B emergency contraception. While it may be true that you are
receiving pressure from the religious right on this issue, the science is clearly in favor of OTC status.
Comparatively we can easily look to other countries which have already labeled Plan B OTC, such as
Canada. Have they had some kind of societal meltdown? Are there disproportionate health consequences
for 15 year olds (that is opposed to the 15 year olds actually getting pregnant and carrying the fetus to
birth)? Forget the morals and politics and look at the science. It has already been too long in the coming,
and americans are actually starting to grasp the incompetence of any scientific agency beholden to
elective branches of government.
COMMENT NUMBER - 2005N-0345-EC32
2005N-0345-EC32 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hagan, Jane
2005N-0345-EC32 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.3.3>I believe the importance of making this drug available to the public is substantial emough that
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the FDA should do whatever is necessary to accomplish that.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
I believe the importance of making this drug available to the public is substantial emough that the FDA
should do whatever is necessary to accomplish that.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2, 4.4.2>Since there is a desire to impose an age restriction on whether this drug is available with or
without a prescription, there should not be significant confusion regarding whether the consumer is of a
certain age or not.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.5.1>The answer to that question should be determined by safety issues only. If the product is safe
for all subpopulations, it should be available to all subpopulations under the same conditions and without
a doctor's prescription. There would be no limitation needed and therefore no law required.
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.4.4>If the product is not safe for all subpopulations based on age, then it should be limited by
physician prescription and by law, and should be practical to enforce since age is provable and easily
documented, particularly the age restrictions that are proposed. Both drivers' licenses and government ID
cards are available for the subpopulations involved.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 6.6.3, 8.4.1>Yes, just as other products such as tobacco and alcohol are limited to certain age
subpopulations, this drug can be limited as well. Assuming enforcement will be at the point of sale,
packaging should not be an issue.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 9.2.1>I cannot think of any, assuming that enforcement of restrictions is done at the point of sale.
GENERAL
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GENERAL
See attachment
2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-
1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-
Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC 2005N-0345-EC32-Attach-1.DOC
ATTACHMENT:
Additional comments as solicited by FDA on Plan B drug approval:
<7: 1.2.1>I have been following the course of approval of this drug for many years. I believe it is
currently the only fair, practical and sane way to handle a very difficult and very personal physical and
mental health issue. I believe this drug also takes the debate out of the realm of disagreement and
confusion about whether a woman's choice to become pregnant or not is tantamount to homicide and
whether the fetus feels pain or not upon early termination of pregnancy.
In my opinion it has already taken far to long, with far too much pain, sorrow and suffering, for this drug
to get to this populations who need it. The FDA appears to be dragging their feet as they continue to
focus on some details that seem spurious at best. Please get these details taken care of in a timely manner
and get this drug out to the people who need it, who are all sexually active women over the age of
puberty.
COMMENT NUMBER - 2005N-0345-EC323
2005N-0345-EC323 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rupp, Charles
2005N-0345-EC323 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.7.2>The FDA needlessly creating controversy and confusion by suggesting that one drug in one
dosage could be two difference products. This is at best a semantic difference (not substantive). This
rulemaking by FDA is generating confusion and not resolving it. No one would suggest that a pint of
whiskey is a different product when held by a minor than when held by an adult. Nor would anyone
believe that a minor attempting to buy a pack of cigarettes makes the pack of cigarettes different from the
pack purchased by an adult. The FDA is asking should rules be issued that would attempt to make such
artificial distinctions. The FDA is suggesting that Plan B purchased for an adult is different from Plan B
prescribed for a minor. The FDA is attempting to say the age of the consumer of a product changes the
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nature of the product. This is patently foolish.
<2: 3.9.1, 6.5.1>The example of ibuprofen cited by FDA in different dosages is in fact two different
products. One, the 200 mg product is safe for the general public to self-medicate; however the 800 mg
product requires significantly more knowledge to be used safely. Treating the 200 mg and 800 mg
dosages of the same ingredient differently is reasonable and proper because of toxicity questions. This is
the type of difference that should be controlled and indeed is at the heart of ?safe and effective? because
the two items are not the same. Would the FDA consider regulating an 800 mg tablet dyed pink
differently than an 800 mg tablet dyed yellow? I think not. The question is about the safety of the drug not
cosmetic differences. The FDA should keep its focus on safety and effectiveness issues not on cosmetic
differences (or non-existent differences).
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
The FDA needlessly creating controversy and confusion by suggesting that one drug in one dosage could
be two difference products. This is at best a semantic difference (not substantive). This rulemaking by
FDA is generating confusion and not resolving it. No one would suggest that a pint of whiskey is a
different product when held by a minor than when held by an adult. Nor would anyone believe that a
minor attempting to buy a pack of cigarettes makes the pack of cigarettes different from the pack
purchased by an adult. The FDA is asking should rules be issued that would attempt to make such
artificial distinctions. The FDA is suggesting that Plan B purchased for an adult is different from Plan B
prescribed for a minor. The FDA is attempting to say the age of the consumer of a product changes the
nature of the product. This is patently foolish.
The example of ibuprofen cited by FDA in different dosages is in fact two different products. One, the
200 mg product is safe for the general public to self-medicate; however the 800 mg product requires
significantly more knowledge to be used safely. Treating the 200 mg and 800 mg dosages of the same
ingredient differently is reasonable and proper because of toxicity questions. This is the type of difference
that should be controlled and indeed is at the heart of ?safe and effective? because the two items are not
the same. Would the FDA consider regulating an 800 mg tablet dyed pink differently than an 800 mg
tablet dyed yellow? I think not. The question is about the safety of the drug not cosmetic differences. The
FDA should keep its focus on safety and effectiveness issues not on cosmetic differences (or non-existent
differences).
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 3.8.4, 4.2>This question can be answer in one word: NO! The FDA is doing the equivalent discussion
of 'how many angels can dance on the head of a pin'? The FDA interpretation of section 503(b) is
straightforward and simple. This notice suggests that FDA will needlessly add complexity to what is
otherwise clear and simple.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 1.2.2, 5.4.3>As stated above, there is no need for additional rulemaking. If the FDA decides that
additional rulemaking is necessary, the FDA should issue emergency rules and not delay yet again
availability of a safe and effective drug. The FDA has already needlessly delayed availability of safe and
effective contraceptive products to American citizens. This delay clearly has been to please a religious
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constituency and not in conformance with the purposes of the act. The FDA should cease its stalling
immediately.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 2.1, 6.6.3>This question is easily and simply answered by looking at the American marketplace
today. It is ordinary practice today to restrict sales of products at the point of sale by the age of purchaser.
Even the smallest ?mom and pop? convenience store routinely enforces such restrictions in sales of liquor
and cigarettes. Waiters and waitresses routinely check the age of customers before serving drinks.
Sporting goods stores have no problem with age restrictions on the sale of firearms. Movie theaters
restrict attendance at movies by age routinely. All of these examples demonstrate the capability of the
marketplace to enforce age related restrictions on product. They also demonstrate that no extraordinary
mechanisms are needed to ?train, inform, etc. retailers on age restrictions on products??age restrictions
are everyday events in the marketplace. These examples also demonstrate that burdensome regulations
about packaging of the products are not needed.
The effectiveness and workability of restrictions at the point of sale by age has been demonstrated in the
American marketplace for years. The FDA should not ignore this demonstration. There is clear, strong
and convincing evidence that age restrictions on sales are enforceable. If the FDA believes that some
additional regulatory authority is needed to require the market to follow age restrictions at the point of
sales, this should be done in emergency rulemaking and not be used as an excuse to further delay OTC
sales.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.4.4>The ordinary events of the American marketplace clearly demonstrated that age restrictions at
point of sale are practical. There is no evidence to suggest that age restrictions on products at the point of
sales are ineffective.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1, 8.3.1, 8.4.1>This question somehow assumes that different products would be sold in the same
package. This is a patently ridiculous assumption. As argued earlier, the age of the purchaser does not
change a product. Regardless of the age the purchaser, the product is the same. Again, FDA seems to be
ignoring common sense to generate controversy and thus a reason to needlessly and inappropriately delay
availability of this safe and effective drug over the counter.
The FDA could reasonably require that the age restrictions be displayed on the packaging for OTC sale.
The FDA should not engage in the burdensome process of requiring one packaging for OTC sales and a
different packaging for prescription sales. Clearly a packaging that shows OTC age restrictions should not
cause any confusion in the mind of pharmacist about sale by prescription. FDA should not require
separate packaging for OTC sales and prescription sales.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
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inappropriate to do so?
. <8: 8.9>This question is another attempt to generate controversy needlessly. The question assumes that a
meaningless distinction has been made and then assumes that the law recognizes the meaningless of the
distinction and then asks the question whether legal sales would be inappropriate. The controversy
suggested in this question exists only in the mind of the questioner.
GENERAL
GENERAL
<9: 3.2>The FDA acted irresponsibly in issuing the advance notice of proposed rulemaking. The FDA
should have done an emergency rulemaking to address the subject of the proposed rulemaking. This
advance notice suggests that the next step will be the issuance of proposed ruling. The use of bureaucratic
steps to delay making a safe and effective drug available to the American citizens is unwarranted.
<10: 1.2.2>The questions in section II clearly miss the essence of the issue. In the press statement
accompanying this notice, it is clearly that the rulemaking process is being used to delay over-the-counter
(OTC) sales of the product known as Plan B. Since time is of the essence in the use of Plan B, using
bureaucratic roadblocks to delay availability of a safe and effective drug deprives many citizens of the use
of the drug during the period of the bureaucratic stalling. This stalling tactic is unethical and repugnant.
The question that should be addressed before all others is: Is there any reason to delay convenient access
(and timely access is essential with the use of Plan B) to a safe and effective drug? The clear and
unambiguous answer to this question should and must be NO! Emergency rulemaking is clearly the
appropriate method to address any procedural questions that FDA perceives. In the absence of substantive
reasons to delay convenient access to this safe and effective drug, the FDA's action should be to make this
drug availability as an OTC product as quickly as possible.
COMMENT NUMBER - 2005N-0345-EC325
2005N-0345-EC325 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Llewellyn, Heather
2005N-0345-EC325 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
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<1: 3.8.4, 7.4.4>If an active ingredient in a drug has been ruled to be physically harmless enough for
over-the-counter distribution, it should be marketed over the counter only. Rule-making codifications
have already been set for drugs with active ingredients that have been ruled to be physically harmless
enough for over the counter distribution but whose distribution might be deemed socially controversial.
Please see the rule-making codification for alcohol and tobacco distribution. ID should be required to
purchase it and guardians and police should be responsible for enforcing socially appropriate use. It is not
the FDA's role to protect the public from physically harmless drugs or to monitor social use of drugs. The
FDA's current "dilemma" is an egregious waste of tax-payer's dollars.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
If an active ingredient in a drug has been ruled to be physically harmless enough for over-the-counter
distribution, it should be marketed over the counter only. Rule-making codifications have already been set
for drugs with active ingredients that have been ruled to be physically harmless enough for over the
counter distribution but whose distribution might be deemed socially controversial. Please see the rule-
making codification for alcohol and tobacco distribution. ID should be required to purchase it and
guardians and police should be responsible for enforcing socially appropriate use. It is not the FDA's role
to protect the public from physically harmless drugs or to monitor social use of drugs. The FDA's current
"dilemma" is an egregious waste of tax-payer's dollars.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.5>I am not confused by the FDA's interpretation. The FDA administration, however, sounds like it's
confused about what to do because it is caught between the scientific findings of the FDA's own scientists
and the political wants of the Presidential administration that appointed it.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.5, 6.6.3>Since I am not confused, it would not help me. It would not help the FDA's administration
either, because then it could no longer delay taking appropriate action on the drug, therefore, putting it
right back between the findings of it's own scientists and the wants of Presidential Administration that
appointed it. In addition, there is no need for new rulemaking, as the rule-making precedent has already
been set by the distribution of alcohol and tobacco.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.5.4>It is not the FDA's role to enforce it's rulings - that is the responsibility of distributors,
guardians and the police.
B. If it could, would it be able to do so as practical matter and, if so, how?
It is not the FDA's role to enforce it's rulings - that is the responsibility of distributors, guardians and the
police.
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3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 6.6.3, 8.1>Of course - but the package should have warnings, just like alcohol and tobacco do.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 6.6.3>The package should have warnings, just like alcohol and tobacco do, preventing any
circumstance that would be inappropriate.
GENERAL
GENERAL
COMMENT NUMBER - 2005N-0345-EC33
2005N-0345-EC33 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Collum, Mark
2005N-0345-EC33 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.1>Plan B should be either OTC or available to be prescribed by a pharmacist. Pharmacists can
verify if a patient is above 16yo, and can then allow it to be dispensed. However, a licensed RPh should
be the one making the decision. This will satisfy the requirements that it only be available to someone
who is 16yo. It will allow a label to be generated and offer the RPh to counsel the patient regarding its
use.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
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<2: 3.1, 3.8.2>Yes. This should either be fully OTC or it should be classified into a category where RPh
can prescribe and dispense it.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.3.3>Yes. It is written entirely in legal jargon which most people cannot understand. In fact, even
highly educated health professional must consult lawyers as to its interpretation. It needs to be worded
such that a "regular" person can understand its provisions. Remove all legal jargon and replace it with
intelligible phrases and words.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.2>NO! More rules only add to the confusion. Medicine & Pharmacy are too highly regulated as it
is. More rules = more confusion.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 7.4.1>Yes. If pharamcists are allowed to prescribe and generate a label for those greater than or equal
to 16yo, anyone who receives it who is under 14yo must have received it from a phycisian. By making
RPh generate their own prescription and treat it as such, there is a tracking method and accountability for
anyone who receives the product.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.3.1.1>By allowing RPhs to treat Plan B as a member of their "prescribing class," you put the
responsibility on their shoudlers. If someone under the age of 16 were to receive the product, it should
have a physician's approval or the RPh would have violated his/her duties as a licensed professional and
be subject to discipline.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.2>No. Their packaging should be different and distinct.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 8.6.4, 9.1.2>It is inapprorpiate to allow one single package to represent two products...that is
deceptive to all parties involved.
GENERAL
GENERAL
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non
COMMENT NUMBER - 2005N-0345-EC34
2005N-0345-EC34 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hudson, Ralph
2005N-0345-EC34 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.3>This question is asked twice in your webpage's form, with minor changes. In response to either
wording, it does not make sense that birth control pills require a doctor's prescription, while an
abortifacient drug may potentially be made available to teenagers without a doctor's professional
guidance. An "active ingredient" is not being marketed for the same purpose in the case of the Plan B
treatment, which is a high-dosage synthetic hormone treatment with the purpose of preventing
implantation, not for the prevention of fertilization, which is the purpose of true birth control pills. The
only valid comparison for allowing an active ingredient to be simultaneously marketed in both a
prescription drug product and an OTC drug product is when the exact same active ingredient is being
used for the exact same medical reason, in the exact same dosage. Allowing an abortifacient to be
marketed OTC, while birth control pills require a doctor's prescription, simply because they both consist
of the same synthetic hormone or combination of hormones (though in significantly different dosages) is
disingenuous to the general public, by misrepresenting the completely different purposes for the
drugs.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
This question is asked twice in your webpage's form, with minor changes. In response to either wording,
it does not make sense that birth control pills require a doctor's prescription, while an abortifacient drug
may potentially be made available to teenagers without a doctor's professional guidance. An "active
ingredient" is not being marketed for the same purpose in the case of the Plan B treatment, which is a
high-dosage synthetic hormone treatment with the purpose of preventing implantation, not for the
prevention of fertilization, which is the purpose of true birth control pills. The only valid comparison for
allowing an active ingredient to be simultaneously marketed in both a prescription drug product and an
OTC drug product is when the exact same active ingredient is being used for the exact same medical
reason, in the exact same dosage. Allowing an abortifacient to be marketed OTC, while birth control pills
require a doctor's prescription, simply because they both consist of the same synthetic hormone or
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combination of hormones (though in significantly different dosages) is disingenuous to the general public,
by misrepresenting the completely different purposes for the drugs.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 1.2.3>When the interpretation is potentially misused, as it may be in the case of the Plan B drug, there
is significant confusion (or rather concern) about the true intentions and motivations behind the decision
to allow an abortion drug to be made available to teenagers, based on the illogical comparison of the acts
of preventing pregnancy with the act of preventing implantation of a fertilized egg.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>It may dispel that confusion, if done correctly, but it will not "dispet" that confusion, as is written
on your webpage.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.5.4>This question requires a legal opinion, which is outside my qualifications. My layman's opinion
is that, in the overly-litigious American society in which we now live, it is inevitable that there will be
lawsuits brought in protest of age discrimination, unless a significant medical reason exists for the
limitation.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.1, 7.3.2>By the same methods currently used to enforce the separation of over-the-counter from
prescriptions.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2>Only if the goal is mass confusion and the complete breakdown of requiring that any drugs are
dispensed only by a doctor's prescription.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 1.2.4>Perhaps if the purpose is to terminate the life of an unborn child.
COMMENT NUMBER - 2005N-0345-EC343
2005N-0345-EC343 - STRUCTURED DATA ELEMENTS
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Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Fisher, Julie
2005N-0345-EC343 - TEXT
Issue Areas/Comments
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 7.5.3>I very much doubt that the FDA would be able to prevent the sale of such a product to the
prescription-only subpopulation by regulating pharmacies. What records are kept for OTC sales? None.
And would nonpharmacy stores be able to carry the OTC product? What regulations would the FDA
impose on convenience stores and grocery stores?
B. If it could, would it be able to do so as practical matter and, if so, how?
<2: 7.2, 7.5.2, 7.5.3>I do not believe there would be any practical way to prevent the OTC product from
finding its way into the prescription-only segment. Pharmacies will sell the OTC product to the
prescription population because there will be no deterrent to doing so. Those in the OTC segment will
purchase the product and pass it on to prescription-only recipients. While the later can and does happen
with drugs currently available only by prescription, such transactions are illegal. Would it be legal for an
OTC consumer to purchase the OTC product and then transfer it to a prescription-only consumer? How
would a ban on the transfer be enforced?
COMMENT NUMBER - 2005N-0345-EC364
2005N-0345-EC364 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: McLeod, Doug
2005N-0345-EC364 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes it should and the decision should be made to allow this action. Especially if the scientific
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evidence supports that decision.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.3.3>Yes it should allow active ingredients to be simultaneously sold as both an OTC and a
prescription drug. This is especially so when the FDA experts have reviewed the drug and indicated that it
should be available as an OTC product.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 1.2.2, 4.1>There seems to be when political pressure overules the science and expert opinion
regarding the drug. For example the Plan B morning after contraceptive has been overwhelmingly rules as
safe yet the FDA seems to be racting in response to political pressure rather than scientific evidence. This
is clearly the wrong direction for the FDA.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.3.1>So long as the rule allowed the practice and supported by the scientific evidence and advice of
the FDA professional staff who should be independent of political influence.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.3.5>This decision should only be taken if there is hard scientific evidence that a subpopulaion
would be harmed. A subpopulation could be by race, age, sex, ethnic origin etc. The FDA should not
make a political,ethical or morality based decision to restrict access to a subpopulation unless the
scientific study group advises it to do so for scientific reasons.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.2, 7.6>It could not, so do nnot try. If the drug is deemed safe by the scientific community for
suitability for OTC, then do not apply further restrictions as to availability.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1, 8.3.1>That is not so much a legal question as a marketing question. Often prescription drugs are
dispensed in different containers than they are shipped to a pharmacy in. For example a large container of
medecine is used to allocate to small vials for dispensing purposes. OTC products, on the other hand, are
often packaged for theft protection, daily dosage packaging, colorful, informative packaging, sale price or
incentive packaging (IE 50% more for free). I would answer YES to this question, but on practical terms,
the packaging for the prescription product could change to adopt to an OTC style.
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B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.1.1>It may be inappropriate for a prescription drug to be packaged in an OTC package when the
volume of the drug, or expected duration of consuption is different. For example, an OTC drug, such as
the Morning After Contraceptive pill may be sold in single dosage OTC packaging, whereas the same
drug could be sold in a daily dosage strength intended to match a womans menstral cycle.
GENERAL
GENERAL
<9: 1.2.2>I have never written to the Food and Drug Administration before, and was motivated to
comment on this particular issue because of an apparent breakdown the FDA leadership to avoid political
influences. In particular, the Plan B, morning after contraceptive drug issue is motivating me to state my
outrage that the scientific community and staff of the FDA are overrules or ignored when political
pressure is applied. This is unconcionable. The FDA decisions should be made on scienctific evidence,
and not by the political desires of a supbopulation.
COMMENT NUMBER - 2005N-0345-EC365
2005N-0345-EC365 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Deneris, Angela
2005N-0345-EC365 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.1>YES!!! We need to make this process much more simple and bring these medications to the
American public sooner.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 1.2.2>YES!!! This is a safe medication which will lower the abortion and unplanned pregnancy rate
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in this country. This medication has extensive study and has very few side effects.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1, 4.3.2>YES! I think the public and providers are very confused about the process and the length of
time it takes to make a decision.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.1>I would think so.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.1, 6.6.3>YES! We do now with tobacco and alcohol. I see no reason that a pharmacist couldn't ask
for ID. They do so now with Schedule I and II medications.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.1, 7.4.4>YES!!! This would not increase the amount of time or money in asking for ID.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1>YES! I see no reason for different packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.2.2>NONE
GENERAL
GENERAL
<9: 1.2.1>I feel this product should be available to every woman needing contraception, regardless of age.
I believe we make it too difficult for people to get this product, which then needlessly subjects women to
unwanted pregnancy. This is tragic. Too many lives are affected. Too many abortions happen that could
be provented. Please pass this medication on to be OTC to EVERYBODY!
COMMENT NUMBER - 2005N-0345-EC38
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2005N-0345-EC38 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Scarpace, Sarah
2005N-0345-EC38 - TEXT
GENERAL
<1: 1.2.3>I am offering a comment specific to the change in status of Plan B to OTC. I am a clinical
pharmacist and assistant professor. I have absolutely no qualms at all about dispensing Plan B OTC and
counseling patients regarding the product; however, I am very concerned that should the drug be available
OTC, that many women will not receive the appropriate triage necessitated in the cases of rape, especially
HIV and STD testing, as well as social work and other psychological support interventions available in
emergency rooms. This would especially be true in the case of date rape and rape by a person known to
the victim, where she may feel ashamed and embarrassed to go to the ER. How would these
circumstances be avoided? <2: 6.5.4>I also do not think that we can strictly enforce the sale of
these products to only age 16 and I am not sure why the drug would not be safe to any young woman who
has reached menarche as the ingredients are the same as the branded birth control pills Nordette (R),
Lotrel (R), etc., which may be used by women younger than 16 to control painful mentstrual periods/
heavy flow. Does a 15 year-old rape victim not have the same rights as a 16 year-old? <3:
6.6.3, 7.5.3>If the drug is approved truly as OTC, where the patient could buy the product out in the aisles
(as opposed to approving for "behind the counter" to be sold by a pharmacist only), would the store front
cashier be responsible for deciding the appropriateness of "carding" a patient for the product to determine
age? We know how effective these young adults are in regards to the sale of tobacco and alcohol! I also
see a danger in not having some type of "screening" to ensure the safety of the patient in the respects
mentioned above in regard to STD screening and social work support - the pharmacist can mention this
during a counseling session but your average high school cashier working at minimum wage is not going
to provide this level of attention (nor should they) to these patients. Please do not regulate the medication
without considering the circumstances surrounding it. <4: 3.8.2, 7.3.1.1>Yes, the
medication itself is likely safe; however, there is special monitoring/intervention required for the
medication which makes professional triage and not OTC availability in the best interest of the patient.
The best scenario is to find a mechanism to ensure that these patients are seen by a physician in the ER,
but the next best option is to at least utilize pharmacists as the fail-safe. Most pharmacists take this
responsibility seriously; the recent media attention regarding pharmacists refusing to fill these
prescriptions was in my view, embarrassing to the profession, but also highlighted a small minority of
practice by pharmacists, probably equal to the percentage of physicians who hold similar ideologies. Thank you for your valuable time in considering these comments.
Sincerely,
Sarah L. Scarpace, Pharm.D.
Assistant Professor of Pharmacy Practice
Albany College of Pharmacy
106 New Scotland Avenue
Albany, NY 12208
phone: (518) 694-7226
fax: (518) 694-7302
email: scarpacs@acp.edu
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COMMENT NUMBER - 2005N-0345-EC399
2005N-0345-EC399 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Tufts, Gillian
2005N-0345-EC399 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes. <2: 1.2, 3.8.3>The manner in which many OTC drugs are used differs from the
manner in which the prescribed drug of the same ingredients is used. For example, rare use of Plan B in
the emergency situation has been found to be safe. The daily use of the same drug, with potential use for
years, does require monitoring and education by a licensed prescriber. Although the drug used in both the
emergent and preventative situations has been found to be safe, there are rare but potential health
consequences with chronic use. In general, oral contraceptives have been taken by millions of women
around the world and are safe.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes, see question A.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>No. <4: 1.2, 3.8.4, 4.4.1>From the brief that I have available, I believe I understand the
intent of the reasoning behind OTC use and prescribed use. Of importance here is the indication of the
drug use. Plan B is to be used only in the emergent situation, after intercourse has occurred, to prevent an
unintended pregnancy. The drug is not meant to be use daily to prevent. "The key distinction in these
examples is that there is some meaningful difference between the two products (e.g., indication, strength,
route of administration, dosage form) that makes the prescription product safe only under the supervision
of a licensed practitioner." The previous quote is from the docket, I believe the key difference is the
indication of the drugs' use.
C. If so, would a rulemaking on this issue help dispet that confusion?
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2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 1.2.1, 6.7>I do not believe it is necessary to limit the use of a drug, specifically Plan B, to
subpopulation. Again, the drug is meant to be used in an intermittent fashion only, like taking tagamet HB
for heartburn. Neither drug is meant to be used on a daily basis. That is where seeing the health care
provider is indication and the information regarding the drug in the drug insert should reflect this.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.5.3>I believe it would be difficult for the person actually selling the product to monitor and enforce
the selling of a product limited by age. <7: 1.2.1>In the case of Plan B, I believe that this may
inhibit some from obtaining the drug much needed in an emergent situation! <8: 6.6.3,
7.4.1>Such enforcement would likely require that the drug be stored 'behind the counter', like cigerettes,
and many women who would benefit from the intended use of the drug would not ask for it.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<9: 8.2>No. <10: 8.6.1>As with many drugs that are available OTC and prescribed, the
indication and manner in which the drug is taken differs. As with Plan B, the indication and number of
pills required for the emergent versus daily use differs. If the number of pills needed and the manner in
which the medication is taken differs then it follows that the packaging should differ. The OTC and
prescribed product appear different because they are different. The intended use and manner in which the
medication is taken is different between the two products.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<11: 8.2, 9.1.1>I do not believe the two products should be sold in a single package. If the intended use of
the two products differs, then so should the packaging and the information in the package inserts.
GENERAL
GENERAL
<12: 3.8.3>As a medical provider, I believe that it is safe to have two products be legally market to the
general public. <13: 8.9>It is very important to have clear the intended use, how to use the
medications, the side effects and what to do if the intended use has not resolved. Often the intended use
for the OTC and prescribed product differs. For example, with oral contraceptives, the daily use is meant
to prevent an unintended pregnancy, whereas the emergency contraceptive, such as Plan B, is meant
ONLY for those situations where no preventative contraception has been used and intercourse has
occurred. <14: 3.8.1>Please consider the changes to the code 503B and permit the use of the
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same ingredient in OTC and prescribed medications. I believe the availability of both products will well
serve the general public.
COMMENT NUMBER - 2005N-0345-EC4
2005N-0345-EC4 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Bilz, Michael
2005N-0345-EC4 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.8>Has it done so for Ibuprofen? It is sold both ways today.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Has it done so for Ibuprofen? It is sold both ways today.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I don't know, is there?
C. If so, would a rulemaking on this issue help dispet that confusion?
<2: 5.5>I'm sure that it would - how long would it take to make a rule? Longer than it did when so many
people were denied access to the Alzheimer's medication that sent so many people back into the darkness
and so many families living with the torment of seeing a loved one suffer? There was a miss-step for the
Agency, as it were.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
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<3: 6.7>Do they have a vehicle for enforcing it now? If so, what is it? Is it effective?
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 6.6.3, 7.4.4>If there were an age limitation - it would become the responsibility of the Pharmacy
provider to determine age - like we do for tobacco and alcohol. Now how does a fifteen year old girl
prove her age without a parent? I sell tobacco to people only with a proper I.D. and I challenge everyone
that looks younger than 27. Like Alcohol + Tobacco - why wouldn't underage persons solicit the help of
someone of legal age to buy this for them? The controls you ask for here have historically had work-
arounds since their inception.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.1, 8.4.1>Why not? They both do the same thing and the manufacturer sells these very same
products in slightly more socially-concious countries and would then raise the cost of the drug by creating
alternate packaging for various applications - and the cost would be passed onto the end-user, not the drug
company.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 9.2.2>I can't think of a situation where it would be an issue.
GENERAL
GENERAL
Dear FDA, I will start by saying that I respect your job and I feel the American consumer is safer, as a
whole, for your agency's regulations on both food and drugs. I understand that it must be a difficult
position to make these tough decisions regulating for people that cannot answer for themselves - and most
of us are unaware of your role in our lives...as it should be. <7: 1.2.1>In regards to the Plan B Emergency
Contraception ruling I believe that it is today, it was yesterday and it will be tomorrow a WOMAN's right
to choose what is best for her body. No MAN should be allowed to legislate one way or another over a
WOMAN's reproductive rights. Plan B E.C. has a specific application and it's use should NOT be
regulated by the 'moral' or 'religious' convictions of any individual. Plan B should be on the shelf next to
all other contraception, accessible to all persons. Yes, I agree that underage girls should be challenged for
proof of age at the register - but first we need to have stronger Health + Sex Education in our school
systems from an early age to allow all persons to be able to make an educated decision on what is best for
their Body AND Mind. We're not stupid, we're just under-educated. Start education early and have an
informed public. Plan B is important for everyone - I'm tired of supporting unwanted pregnacies through
social programs that show children as a dollar figure to a poor family. Reform the social welfare systems
and EDUCATE the population - STARTING TODAY..!!
Thank you for listening.
Sincerely,
Michael L. Bilz
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COMMENT NUMBER - 2005N-0345-EC405
2005N-0345-EC405 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kulshrestha, Vikram V
2005N-0345-EC405 - TEXT
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.1>Yes
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 7.5.3>In my opinion, it will not be possible to ensure the misuse.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.2>No.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.2>No
GENERAL
GENERAL
<5: 8.5.4>It seems practically tricky to control the marketing of the same molecule for same indication in
a single package as both prescription & OTC drug. In my personal opinion, a drug (molecule) can be sold
as Prescription and OTC product with two different BRAND names. One brand can be marketed as a
Prescription drug and the other one as the OTC, thus with two different Packaging.
<6: 7.5.3>But, the question is ?How the misuse of the same will be prevented by FDA, as the drug will be
ultimately available to the subpopulation by a different route ?
So, it is not preferable to market same molecule as both a Prescription and OTC product for same
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indication.
And it does not seem possible for FDA to enforce a check for limiting the sale of OTC product to a
specific population even if the product is labeled for OTC and or Prescription.
COMMENT NUMBER - 2005N-0345-EC408
2005N-0345-EC408 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Labbe, Carl
2005N-0345-EC408 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.2>I believe that there are very sound arguements to initiate a rulemaking to define a
transitional class of drugs that would be pharmacy-only drugs. Although there is some precedent for
concurrent Rx and OTC marketing of drug products, there is much to gained by defining a pharmacy-only
class of drugs. Pharmacists already have the skills, knowledge and most importantly, the mechanisms to
properly distribute medications based on specific medical and legal criteria.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
See above comments
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes, the section is open to various interpretations.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>Yes
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
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available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2>Not under current rules.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.4.1>Again, I suggest letting pharmacies, i.e. pharmacists, manage the distribution of medications
that have been Rx and may not quite ready for the broad, unlimited distribution that comes with OTC
status in the country.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.5.1>As I see it, under current regulations, different labeling is required.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.1>Certain, product-specific information or condition-specific information may need to be
presented in different ways to different individual patients.
GENERAL
GENERAL
<8: 3.8.2, 7.4.1>It is a good time to give careful consideration to creation of a third Pharmacist Only class
of medications in this country. Under our current system, medications make a giant leap from the very
restricted and regulated prescription distribution system to the incredibly extensive non- prescription
marketplace. Making some of these medications so widely available may not be in the best interest of
patients' health. Granting pharmacists control over a specific group of prescription medications might
serve to improve care in a cost-effective manner. Pharmacists know that they have tremendous impact on
their patients' health when they advise and guide the selection and use of medications. Numerous studies
have demonstrated the value in both dollars and outcomes when pharmacists are involved in drug therapy
management. A third class of drugs would provide consumers with more choices and give them access to
professional guidance toward effective health care. Of course, the added benefit would be that
pharmacists would enhance the triage function that they already provide, referring patients for physician-
provided medical care when indicated. A pharmacist-only class of drugs would be in the best interests of
our patients and would have little negative impact on corporate profit margins or on physicians' ability to
provide medical care. Actually, there is great potential to broaden the availability of consumer products
and enhance the delivery of medical care. This is an idea whose time has finally come. The idea of a
pharmacy-only class of drugs is also being considered and may serve as an important transitional step
toward a more intelligent distribution system for the myriad of drug products available in this country.
Think about the possibilities!
Remember, the purpose of the third class would be to improve access to beneficial medications, not
restrict access to OTC products.
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COMMENT NUMBER - 2005N-0345-EC416
2005N-0345-EC416 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Thompson, Donald
2005N-0345-EC416 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.3, 3.1, 3.8.4>Yes. The rulemaking should state that an active ingredient cannot be simultaneously
marketed in both prescription and OTC product forms. Either the concerns about biologic safety and
regulatory safety are sufficiently low that there is no need for a prescription, or the concerns are
sufficiently great to keep it prescription only. Biologic safety issues for estrogens and progesterones have
always been enough of a concern that oral contraceptives have been available by prescription only. It
seems to be a dilution of regulatory policy and responsibility to permit any estrogen/progesterone product
to be available OTC.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes. The rulemaking should state that an active ingredient cannot be simultaneously marketed in both
prescription and OTC product forms. Either the concerns about biologic safety and regulatory safety are
sufficiently low that there is no need for a prescription, or the concerns are sufficiently great to keep it
prescription only. Biologic safety issues for estrogens and progesterones have always been enough of a
concern that oral contraceptives have been available by prescription only. It seems to be a dilution of
regulatory policy and responsibility to permit any estrogen/progesterone product to be available OTC.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 2.2, 4.1>Yes. I do not understand FDA's interpretation of section 503(b) of the act. I applaud
Commissioner Crawford's recognition that regulatory policy issues must consider more issues than simply
the scientific safety concerns. Observations of human behavior strongly suggests that alterior motives
often lead to misuse and abuse of prescription, OTC, and illegal drugs and other substances, such as
Scheduled narcotics, alcohol, and tobacco products, leading to a great degree of pain and suffering. FDA
must consider all these issues and issue rules that protect vulnerable populations to the greatest extent
possible.
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C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>Yes. See above.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2, 6.7>No, neither FDA nor state and local authorities would be able to enforce such limitations.
Law enforcement and regulatory activities are often low on the priority list for local officials compared to
violent crime, so such legal enforcement is very unlikely to occur.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2, 7.5.3>I don't see how such a limitation could be enforced. Our nation has a long history of minors
getting access to many drugs and substances that are not legal, such as alcohol and tobacco, for which
there is only a personal desire for gratification. Prevention of pregnancy with OTC emergency
contraception opens the door to sexual predators who could easily purchase the medication OTC, then
require their victims to use it. The scientific literature is clear on adolescent decision making processes
and risk taking for short term gain. FDA regulatory guidelines must protect this vulnerable
population.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2, 9.1.1>No. If there is any rational reason for allowing an ingredient to be marketed both by
prescription and OTC, the packages must be different, the labels must be different, the warnings must be
different, and the limitations on access must be enforceable.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.1>Anytime there are biologic or behavioral safely issues associated with access to the products, it
would be inappropriate to sell such a product in the same package.
GENERAL
GENERAL
<8: 1.2.3>Prescription access to emergency contraception does not place an unreasonable burden on its
availability. It protects vulnerable young women from sexual abuse and violence, to some degree, and
requires all users to consider the possible outcomes of their actions. Healthy behaviors and healthy
choices are to be strongly encouraged by our society and our governmental agencies, including
responsible diets and exercise, reducing tobacco use, and moderating alcohol use. Increased access to
emergency contraception is likely to increase the sexual abuse of vulnerable teenagers, and is unnecessary
for responsible persons who are over 18 years of age.
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COMMENT NUMBER - 2005N-0345-EC418
2005N-0345-EC418 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Schulman, Marvin
2005N-0345-EC418 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.9.1>I can find no problem with allowing the same ingredient for both prescription and OTc. I
believe this has already been done with many components, the only difference being dose levels. for
example, folic acid tablets are OTC but at the 1mg level or higher, they require a prescription
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes. I can find no problem with this . please see above
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.1>Yes.
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.1, 7.4.6>Such a requirement is commonly done with cigarettes sold in Pharmacies. Enforcement is
left to the local merchant.
3
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A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 7.5.3, 8.1>Why not. What is the issue here. If it is the same ingredient at the same dose, why would it
remain a prescription. Noone will bother to obtain a prescription
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 9.2.2>None
GENERAL
GENERAL
<7: 4.3.3>I really don't understand the FDA's view of this matter. The issue is much simpler. If a product
is safe for OTC sales, it should be available. It is irrelevant, If it also available as a prescription, in the
same or a differnt package. <8: 6.6.3>I also believe that few people will seek a prescription if
the same product is available OTC. The enforcement issue is bogus. Currently, most pharmacies also sell
cigarettes and are required not to sell them to children. The current means of enforcing this rule as well as
the one that prevents sale of prescription drugs with a proper prescription should suffice.
<9: 2.1>It appears to me that the FDA has created some irrelevant issue to stall approval of Plan B
because the politics surrounding this drug. It is not the FDA's job to worry about sociol or moral conduct
but evaluate drugs and allow useful to available to those who need them.
COMMENT NUMBER - 2005N-0345-EC426
2005N-0345-EC426 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Duchon, Kathleen
2005N-0345-EC426 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.3>Yes, as a consumer and a woman, there should be guidelines as to under 16 years of age
use. But, as an adult that option to buy a drug OTC should be available.
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1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.1>Yes, times are we a consumer can get a product in illegal ways. Why not make it a safe consumer
choice?
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>No, but it does need to be update as the world issues broaden and expand
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1, 6.6.1>Why not? They have enacted other new procedures such as ID for antihistamines. Why
could the same implementation be put into affect for other drugs?
B. If it could, would it be able to do so as practical matter and, if so, how?
see above
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.2>No, I would think to clarify the confusion you would have to mandate different packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 9.1.1>When it is given to an under age consumer
COMMENT NUMBER - 2005N-0345-EC43
2005N-0345-EC43 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Lamermayer, Richard J
2005N-0345-EC43 - TEXT
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Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No. <2: 3.8.8>This would open up pandora's box as there would be a review of dozens
(maybe hundreds?) of other molecules that might "need" to be reevaluated as to their prescription/OTC
status.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>NO. <4: 4.4.2>Although there may SEEM to be so, such confusion is primarily claimed
by those who are not entirely familiar with all the circumstances surrounding specific applications of Sec.
503(b).
C. If so, would a rulemaking on this issue help dispet that confusion?
<5: 5.2, 5.4.2.2>Further rulemaking would merely open up additional areas of question and urge lawyers
and medical personnel to find new avenues for advancing their personal (or constituent) agendas.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<6: 6.1>Legally, FDA would probably be able to enforce such a limitation. <7: 7.2, 7.5.3,
7.5.4>In practice, this would raise the cost of prescription services and would probably not result in
equitable and accurate enforcement.
B. If it could, would it be able to do so as practical matter and, if so, how?
<8: 7.2>Probably not, as mentioned above
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<9: 8.2>NO. <10: 7.5.3>Any violation of the prescription product's sales would be virtually
unenforceable from a practical standpoint.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
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<11: 6.5.4>If the drug were so HARMLESS as to be sold primarily OTC in the first place. But this begs
the question, why sell it by prescription then?
COMMENT NUMBER - 2005N-0345-EC447
2005N-0345-EC447 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Anspach, Kurt
2005N-0345-EC447 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.3.3>If it were safe to take theses pills without a prescription in one form then how can it not be for
another use?Thats a double standard.Most of the population that will be taking these pills won't
understand that this shouldn't be done without being advised and supervised by a Doctor.<2:
7.5.3>There wouldn't be any control over who buys these pills.Why fool ourselves saying lets put a age
limit on them.After all is possible to purchased anything at any time.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.5>Parts of the statement is good but how many people know the process of filing a complaint?This
issue is a very important issue and it should be brought to the attention of the population throught the
media.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.2>no!<5: 5.4.2.2> If there was a rulemaking how would the people know were to look for
it?How many people know to go on the FDA website?
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
no It wouldn't make any difference if the person wants them they will get them.
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GENERAL
GENERAL
see attachment
2005N-0345-EC447-Attach-1.PDF 2005N-0345-EC447-Attach-1.PDF 2005N-0345-EC447-Attach-
1.PDF 2005N-0345-EC447-Attach-1.PDF 2005N-0345-EC447-Attach-1.PDF
ATTACHMENT:
<6: 1.2, 10>IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF
PENNSYLVANIA
CIVIL ACTION No. 05-810
MELISSA ANSPACH, KURT A. ANSPACH, KAREN E. ANSPACH,
Plaintiffs,
v.
CITY OF PHILADELPHIA, DEPARTMENT OF PUBLIC HEALTH, et al,
Defendants.
MEMORANDUM AND ORDER
JOYNER, J. June 27, 2005
Via the instant Motion, Defendants John F. Domzaliski, Louise Lisi, Maria Fedorova, Mary Gilmore, and
the City of Philadelphia move to dismiss Plaintiffs' Complaint. Because Plaintiffs have failed to state a
claim under federal law, this action must be dismissed for lack of federal question jurisdiction.
Factual Background
On January 26, 2004, Plaintiff Melissa Anspach visited a Health Center operated by the City of
Philadelphia Department of Public Health. Melissa, who had engaged in sexual activity on January 23,
2004, believed that she might be pregnant and requested a pregnancy test. Plaintiffs allege that Melissa
was told by a receptionist that she could not obtain a pregnancy test "because it was not family planning
day." Melissa left the Health Center, but returned shortly thereafter at the prompting of a friend, who told
Melissa to "ask for the morning after pill." Melissa followed this advice and was directed to the pediatric
ward, where she provided her name and date of birth, indicating that she was sixteen years of age. See
Complaint, ¶ 22-26.
Plaintiffs allege that Melissa next spoke with Defendant Maria Fedorova, a social worker, for
approximately ten minutes, during which they discussed sexually transmitted diseases, birth control, and
emergency contraception. Ms. Federova allegedly told Melissa that the Health Center could provide pills
"that would prevent [her] from getting pregnant," and Melissa agreed to take these pills. Defendant Mary
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Gilmore, a registered nurse, then took Melissa's temperature and blood pressure, and provided Melissa
with emergency contraception marketed under the trade name Nordette. [Footnote 1: This method of
emergency contraception, also known as the "morning-after pill," uses a combination of progestin and
estrogen to prevent pregnancy. Depending on the phase of the patient's menstrual cycle, emergency
contraception may prevent ovulation or fertilization. If fertilization has already occurred, emergency
contraception may alter the endometrium to prevent implantation of the fertilized egg. If a fertilized egg
has already implanted in the endometrium, emergency contraception will have no effect. See
http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm.] Nurse Gilmore told Melissa to take
four pills right away and then four more in twelve hours. Plaintiffs contend that before Melissa took the
pills, Nurse Gilmore consulted with Ms. Federova "to find out how Melissa should take the pills," and
consulted with Defendant Jitendra Shah, a physician, to ask if Dr. Shah wanted to examine Melissa. After
Melissa took the pills in Defendant Gilmore's presence, she allegedly asked whether the pills would make
her sick. Nurse Gilmore reportedly consulted with Dr. Shah once again, who advised Nurse Gilmore to
tell Melissa to drink ginger ale. See Complaint, ¶ 26-34.
After taking her second dose of pills at approximately 4:00 A.M. on the morning of January 27, 2004,
Melissa experienced severe stomach pains and began vomiting. Melissa's father, Plaintiff Kurt Anspach,
came to her room and found Melissa lying on the floor. Mr. Anspach contends that Melissa's face was
swollen and red, and that Melissa asked if she was going to die. Upon learning that Melissa had taken
emergency contraception, Mr. Anspach called their family physician and the poison control center, and
took Melissa to the emergency room. Melissa was released from the hospital the same day, but returned
because of sub-conjunctive hemorrhaging in her eye resulting from excessive vomiting. Melissa Anspach
and her parents contend that the events described above have caused them to suffer severe emotional
distress. See Complaint, ¶ 35-38.
Plaintiffs bring the instant action against Defendants, maintaining that their state and federal
Constitutional rights were violated as a result of Defendants' actions. Mr. and Mrs. Anspach contend that
they were deprived of their right to familial privacy when Defendants provided Melissa with medication
without her parents' consent. Similarly, Melissa contends that Defendants' actions deprived her of the
opportunity for parental consultation and guidance. She has also raised a claim of assault and battery
against Defendants Federova and Gilmore for dispensing medication without Melissa's informed consent.
Melissa contends that she was told that emergency contraception would prevent her from becoming
pregnant, but was never informed that the pills could cause miscarriage or termination in the event she
was already pregnant. Plaintiffs further bring claims of negligent supervision against Dr. Shah, and
negligent and intentional infliction of emotional distress against the individual Defendants.
Standard of Review
In considering a motion to dismiss, a court must consider only those facts alleged in the complaint and
accept all of the allegations as true. Morse v. Lower Merion Sch. Dist., 132 F.3d 902, 906 (3rd Cir. 1997).
However, the court need not credit the plaintiff's "bald assertions" or "legal conclusions" where such
conclusions are unsupported by the pleadings. Morse, 132 F.3d at 906. A motion to dismiss may only be
granted where the plaintiff's allegations fail to state any claim upon which relief could be granted. Morse,
132 F.3d at 906.
Discussion
To state a cause of action for state deprivation of a constitutional right, a plaintiff must allege that he was
deprived of a federal right by a defendant acting under color of state law. 42 U.S.C. § 1983; Gomez v.
Toledo, 446 U.S. 635, 640 (1980). In Count I, Mr. and Mrs. Anspach contend that they were deprived of
their fundamental right to direct the rearing and education of their minor child as a result of Defendants'
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course of conduct. In Count II, Melissa Anspach alleges that Defendants deprived her of her right to
parental guidance and advice in matters relating to medical care. Both counts arise out of the liberty
interests granted by the Due Process Clause of the Fourteenth Amendment. Plaintiffs also allege that
Defendants violated their First Amendment right to free exercise of religion by providing Melissa with a
medication that can cause termination of a pregnancy, defined under Pennsylvania law as commencing
with fertilization. 18 Pa. C.S. 3203.
I. Rights of Parental Guidance and Familial Privacy
It is well established that the fundamental right of parents to direct the upbringing and education of their
children is protected by the Due Process Clause of the Fourteenth Amendment. Troxel v. Granville, 530
U.S. 57, 65 (2000); Wisconsin v. Yoder, 406 U.S. 205, 232 (1972); Prince v. Massachusetts, 321 U.S.
158, 166 (1944); Pierce v. Society of Sisters, 268 U.S. 510, 534-35 (1925). This right, however, is not
absolute. The state has a wide range of power to limit parental freedom in matters relating to child
welfare. Prince, 321 U.S. at 167. Furthermore, the right of a parent to direct a child's upbringing cannot be
understood in isolation. Minors, as well as adults, are protected by the Constitution and possess
fundamental rights that may in some instances outweigh those possessed by their parents. Carey v.
Population Servs. Int'l, 431 U.S. 678, 692 (1977) (quoting Planned Parenthood of Central Missouri v.
Danforth, 428 U.S. 52, 74 (1976)).
A. No State Interference with Parent-Child Relationship
Even viewing the facts of the Complaint in their most favorable light, Plaintiffs have failed to state a valid
claim for relief arising from violation of the above-described parental rights. Plaintiffs maintain that when
Melissa Anspach visited the Health Center, Defendants were aware that she was only sixteen, but never
asked Melissa whether her parents knew of her predicament, nor advised her to consult with her parents
before deciding whether to take emergency contraception. Complaint, ¶ 27, 28. In Counts I and II of their
Complaint, Plaintiffs conclude that Defendants' course of conduct "was intended to influence Melissa to
refrain from discussing with her parents her possible pregnancy and what course of conduct was
appropriate," and violated Mr. and Mrs. Anspach's rights "by usurping the parental role." Id., ¶ 67, 68, 72,
77. This Court cannot credit Plaintiff's legal conclusions, however, as they are entirely unsupported by the
factual allegations in the Complaint concerning Melissa's interaction with the Health Center staff.
Plaintiffs do not maintain that Defendants instructed Melissa not to consult with her parents or otherwise
prevented her from seeking their guidance and advice with respect to reproductive matters. At best,
Plaintiffs have alleged only that Defendants failed to encourage Melissa to seek her parents' assent. Such
passive failure on the part of a state agency and its employees cannot form the basis of a constitutional
claim of the kind raised by Plaintiffs.
In the key cases defining the scope of the fundamental parental right to control a child's rearing and
education, the Supreme Court has held that a state may not forbid parents from educating their children in
accordance with their beliefs. See Yoder, 406 U.S. at 232-34 (compulsory high school education as
applied to Amish minors); Pierce, 268 U.S. 510, 534-35 (compulsory education within the public school
system); Meyer v. Nebraska, 262 U.S. 390, 400 (1923) (statute prohibiting teaching of foreign
languages). Plaintiffs have identified no authority, however, to suggest that the scope of these cases can
be expanded to allow constitutional claims against states that permit parental involvement but merely fail
to take steps to encourage more active parental participation. This fundamental legal distinction was
highlighted in 1980 by the Sixth Circuit Court of Appeals, in connection with a challenge to the Michigan
Health Department's provision of contraceptive information and services to minors without parental
notification. Doe v. Irwin, 615 F.2d 1162, 1168 (6th Cir. 1980), cert. denied, 449 U.S. 829 (1980). The
Sixth Circuit found that earlier Supreme Court cases dealt only with states "either requiring or prohibiting
some activity." Id. In contrast, the state of Michigan, in establishing a voluntary birth control clinic,
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"imposed no compulsory requirements or prohibitions" affecting the rights of the parent- plaintiffs. Id.
The court explained its findings as follows:
There is no requirement that the children of the plaintiffs avail themselves of the services offered by the
Center and no prohibition against the plaintiffs' participating in decisions of their minor children on issues
of sexual activity and birth control. The plaintiffs remain free to exercise their traditional care, custody
and control over their unemancipated children. Id.
We find the Sixth Circuit's interpretation of Supreme Court precedent on the issue of parental rights to be
compelling. See also Parents United for Better Schs. Inc. v. Sch. Dist. of Pa. Bd. of Educ., 148 F.3d 260,
276 (3rd Cir. 1998) (favorably citing the reasoning of Irwin in upholding a voluntary condom distribution
program in Philadelphia schools). In establishing a voluntary health clinic, the state of Pennsylvania has
neither required that minors within the Commonwealth avail themselves of its services, nor prohibited
parents from participating in their children's educational, moral, or physical upbringing. Thus, Plaintiffs
have failed to state a constitutional claim for violation of Mr. and Mrs. Anspach's right to direct the
upbringing of their minor child, Melissa. For the same reasons, Plaintiff Melissa Anspach has failed to
state a constitutional claim for violation of her right to receive parental guidance.
B. No Parental Right to Be Notified of a Minor Child'sExercise of Reproductive Privacy Rights
Even if Plaintiffs' Complaint did allege facts sufficient to support a finding that Defendants' actions
prevented Mr. and Mrs. Anspach from counseling their daughter, there is an alternative ground for
dismissal of Plaintiffs' claims. There is simply no constitutional basis to support Plaintiffs' contention that
parents have a constitutional right to be informed of their minor child's request for family planning
services.
Minors, as well as adults, have a fundamental right to privacy in the intimate area of reproductive
decision-making. See Carey, 431 U.S. at 692 (citing Danforth, 428 U.S. at 74). States that have adopted
policies aimed at protecting this privacy right, however, often face challenges from parents alleging
intrusion upon the sphere of familial privacy and parental guidance. In Danforth, for example, the
Supreme Court considered the interplay between the reproductive rights of minors and the rights of their
parents in the context of a Missouri law requiring parental consent to abortion for minors. Danforth, 428
U.S. at 74-75. Finding the absolute parental consent requirement unconstitutional, the Court held that a
parent's independent interest in terminating or continuing a minor daughter's pregnancy is "no more
weighty than the right of privacy of the competent minor mature enough to have become pregnant." Id. at
75. In a plurality opinion the following year, the Supreme Court found that the decision in Danforth "a
fortiori foreclosed" any absolute prohibition on the distribution of contraceptives to minors without
parental consent. Carey, 431 U.S. at 694. Thus, to the extent that Plaintiffs object to Defendants' failure to
obtain the consent of Mr. and Mrs. Anspach before prescribing emergency contraception to Melissa
Anspach, their constitutional claims must fail as a matter of law.
To the extent that Plaintiffs seek recovery on the basis of Defendants' failure to notify Melissa's parents of
her request for emergency contraception, their claim must fail as well. There is absolutely no authority
before this Court to support the proposition that a parent's right to be notified that their child has sought
out family planning services outweighs the minor child's interest in reproductive privacy.
While the Supreme Court has upheld the constitutionality of parental notice requirements under some
circumstances, the Court has never held that parents have a constitutional right to such notification, either
with respect to contraception or abortion. [Footnote 2: Plaintiffs contend that the standards governing
abortion should govern discussion of emergency contraception, because emergency contraception can
result in the termination of a pregnancy, defined under Pennsylvania law as a fertilized embryo. See 18
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Pa. C.S. 3203. This Court declines to determine whether emergency contraception is closer in kind to
traditional methods of birth control or to chemically-induced abortion. For this reason, we will consider
the law governing parental notification in the context of both abortion and contraception.] See, e.g.,
Lambert v. Wicklund, 520 U.S. 292, 297-98 (1997) (per curiam); Ohio v. Akron Ctr. for Reproductive
Health, 497 U.S. 502, 510-11 (1990); H.L. v. Matheson, 450 U.S. 398, 409-10 (1981); See also Irwin, 615
F.2d at 1169 (finding that the opinions in Carey do not indicate that parents have a constitutional right to
notification). Rather, the language used by the Supreme Court suggests that parental notification
requirements pose significant constitutional challenges, and may be struck down if they do not provide
minors seeking abortions with opportunities for exemption or judicial bypass. [Footnote 3: The Supreme
Court has similarly held that statutes imposing an absolute requirement of parental consent are
unconstitutional, finding that the failure to provide judicial bypass or other exemption procedures imposes
an undue burden on a minor's right to choose. See Ohio v. Akron Center for Reproductive Health, 497
U.S. at 511; City of Akron v. Akron Center for Reproductive Health, 462 U.S. 416, 440 (1983); Bellotti
v. Baird, 443 U.S. 622, 651 (1979) (plurality).] See, e.g.,Hodgson v. Minnesota, 497 U.S. 417, 450-55,
461 (1990) (finding Minnesota's two-parent notice statute unconstitutional without procedures for judicial
bypass); Lambert, 520 U.S. at 297-98 (upholding Montana notice statute with judicial bypass procedure);
Ohio v. Akron Ctr. for Repro. Health, 497 U.S. at 510-11 (applying Bellotti bypass procedures to uphold
Ohio notice statute); Matheson, 450 U.S. at 409 (upholding Utah parental notification law as applied to an
immature, unemancipated minor seeking abortion); See also Planned Parenthood v. Heed, 390 F.3d 53
(1st Cir. 2004); Planned Parenthood of the Rocky Mts. Servs. Corp. v. Owens, 287 F.3d 910 (10th Cir.
2002); Planned Parenthood v. Miller, 63 F.3d 1452 (8th Cir. 1995).
Furthermore, numerous courts have held that parental notice requirements in the context of contraception
and family planning services are inconsistent with Title X, which imposes a burden of confidentiality on
providers of such services. 42 C.F.R. § 59.11; See, e.g., County of St. Charles v. Missouri Family Health
Council, 107 F.3d 682, 684-85 (8th Cir. 1997); New York v. Heckler, 719 F.2d 1191, 1196-97 (2nd Cir.
1983); Planned Parenthood Fed. of Am. v. Heckler, 712 F.2d 650, 656-61 (D.C. Cir. 1983).
In light of the above authorities, Plaintiffs are wrong to suggest that they have a constitutional right to be
notified of their daughter's request for emergency contraception. Thus, Counts I and II fail to state valid
constitutional claims.
II. Right to Free Exercise of Religion
Plaintiffs also maintain that Defendants violated their right to free exercise of religion by providing
Melissa with a medication that can cause termination of a pregnancy. Although the parties have not
briefed this issue, this Court finds that Plaintiffs have failed to state a valid cause of action for violation of
their rights under the Free Exercise Clause of the First Amendment.
In merely alleging that Defendants "gave [Melissa] a substance that, in some cases, may result in the
termination of a pregnancy," and that Melissa would not have taken the pills had she known of this
potentiality, Plaintiffs have failed to plead any constitutionally relevant injury in fact. See Complaint, ¶
74, 80. Plaintiffs do not allege that Melissa was pregnant at the time she took the emergency
contraception, nor do they allege that Defendants' actions actually resulted in the termination of a
pregnancy in violation of Melissa's religious beliefs.
Furthermore, the facts of the Complaint, viewed in the light most favorable to Plaintiffs, do not suggest
that Defendants "placed a substantial burden on [Plaintiffs'] observation of a central religious belief or
practice." See Hernandez v. Commissioner, 490 U.S. 680, 699 (1989). Plaintiffs admit that Melissa
voluntarily requested "the morning after pill," and do not allege that she made any inquiries as to the
effect of emergency contraception on a fertilized ovum. Rather, Plaintiffs merely contend that Melissa
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was misled by the designation "emergency contraception" in the literature provided by the Department of
Health. Moreover, Plaintiffs do not maintain that Defendants compelled Melissa to take the pills, or
otherwise prevented her from consulting with her parents or religious advisors regarding the implications
of her decision.
Finally, it is well established that parental liberty interests are not violated merely because religious
beliefs are implicated in the claim. Irwin, 615 F.2d at 1168 (citing Prince, 321 U.S. at 166).
Conclusion
This Court recognizes that parental guidance is invaluable to a child's moral, social, and religious
development. Parental involvement is particularly important during the period of adolescence, when
children struggle with weighty issues of peer pressure and sexuality. Within any family unit, parents and
their adolescent children have a shared responsibility to engage in discussion of personal and family
values, and to learn from each other's perspectives. These ideals are reflected in the Due Process Clause
of the Fourteenth Amendment, which protects the fundamental right of parents to direct the upbringing
and education of their children.
Plaintiffs interpret this parental right to require that public health centers disclose to parents a minor
child's request for family planning services. In doing so, Plaintiffs stretch the boundaries of this
constitutional doctrine to the breaking point. The Health Center's failure to notify Mr. and Mrs. Anspach
of their daughter's request for emergency contraception in no way prevents Plaintiffs from discussing
responsible sexual activity or religious doctrine at home. Furthermore, Mr. and Mrs. Anspach's rights
under the Due Process Clause do not include the right to receive state notification upon their minor
daughter's exercise of her fundamental right to privacy in reproductive decision-making.
In sum, Plaintiffs' allegations fail to state any constitutional claim upon which relief could be granted. As
there is no federal question remaining before this Court, this action shall be dismissed for lack of
jurisdiction.
An appropriate Order follows.
IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF
PENNSYLVANIA
CIVIL ACTION No. 05-810
MELISSA ANSPACH, KURT A. ANSPACH, KAREN E. ANSPACH,
Plaintiffs,
v.
CITY OF PHILADELPHIA, DEPARTMENT OF PUBLIC HEALTH, et al,
Defendants.
ORDER
AND NOW, this 27th day of June, 2005, upon consideration of the Motion to Dismiss filed by
Defendants John F. Domzaliski, Louise Lisi, Maria Fedorova, Mary Gilmore, and the City of Philadelphia
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(Doc. No. 6), and Plaintiffs' response thereto (Doc. No. 14), it is hereby ORDERED that the Motion is
GRANTED and this action is dismissed for lack of subject matter jurisdiction.
BY THE COURT,
s/J. Curtis Joyner
J. CURTIS JOYNER, J.
COMMENT NUMBER - 2005N-0345-EC47
2005N-0345-EC47 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Clason, Dennis
2005N-0345-EC47 - TEXT
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 6.1, 6.6.3>It seems rather clear that both State and Federal bodies regulate and enforce product
restrictions to particular subpopulations. The legal age for alcohol consumption is 21 years in all 50 states,
and this age limit is enforced by both the various States and by Federal agencies (e.g., Department of
Defense). Many States have laws and regulations which control the distribution of tobacco products to
those over an age limit, and they are able to enforce their laws and regulations. Other substances
controlled in similar ways include inhalants (toluene-containing glues and aerosols) and spray paints.
Clearly, if it is permissible for State and Federal agencies to restrict distribution of certain compounds by
age, it is both permissible and possible for the FDA to do so.
B. If it could, would it be able to do so as practical matter and, if so, how?
<2: 7.1, 7.4.4, 7.4.5>Of course it is. Age limits can be enforced for new drugs in the same way they are
enforced for casually used drugs like nicotine and ethanol. Spot check purchase attempts by individuals
who appear to be underage and have an underage ID would suffice to control distribution. The FDA can
set appropriate fines and penalties for violation of the distribution rules it sets up.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<3: 9.1.1>If the indications were different for the OTC and prescription products, I would expect that
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different packaging would be required and reasonable. <4: 8.4.1, 9.2.1>If the indications are
the same for the OTC and prescription product, then I think that differentiated packaging is silly.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
See above.
GENERAL
GENERAL
<5: 1.2, 2.1>This is without a doubt one of the silliest and most blatantly political exercises the FDA has
ever engaged in. The political appointees in the Agency really ought to quit playing footsie and make a
decision on the Barr application -- approve it, or disapprove it, but follow your own rules regarding
applications.
COMMENT NUMBER - 2005N-0345-EC49
2005N-0345-EC49 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Landauer, Christopher
2005N-0345-EC49 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.3>The FDA has a responsibility to determine what medications can be safely self admisnistered.
However in this case, the use of the medication will set a precedent that will be unheard of. There are
ample methods of contraception available in the marketplace and there is no reason for a medication of
this nature. It was uncontionable that the agency ever approved a medication of this nature in the first
place, but now that it is approved, it should remain a perscription drug that doctors should only perscribe
on a case by case basis.
I would hope that the agency would be responsible to ensure that this madication and any others like it
remain perscription drugs.
2
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A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.2, 6.5.1, 7.2, 7.5.2>No, the agency does not have the capacity to enforce a perscription program to
any subpopulation. The agencies responsibility is to ensure that only safe, ethical drugs are allowed in the
marketplace. The agency does not have the ability to enforce age limitations with respect to perscription
drugs. Hence this drug product should only be perscribed by a medical professional.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.5.1>No the agency does not have the authority to comply w/ this.
3
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<4: 1.2.3>This product should never be sold over the counter. That would be negligent of the agency to
allow something like that to happen.
GENERAL
GENERAL
<5: 1.2.3>I think the agency is putting itself on a slippery slope with the decision on this issue. I think it
would remain in the best interest of the general public to keep this and other medications as perscription
drugs. This way a trained professional can make a rationale decision on the availability of this product.
This product does not have much redeeming value in general.
COMMENT NUMBER - 2005N-0345-EC495
2005N-0345-EC495 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Stier, Christopher
2005N-0345-EC495 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
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Yes. While the current interpretation seems reasonable, a lack of codification leaves open a great deal of
subjectivity with respect to what is meant by a "meaningful difference" between a prescription product
and an OTC product. This codification should go beyond simple differences (e.g., strength, dosage) and
require that clinical trials form the basis for any OTC branding - in order to ensure the safety of the
population or any subpopulation for which the OTC version is being made available.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.1>Yes. <2: 3.8.1, 3.11>While the current interpretation seems reasonable, a lack of
codification leaves open a great deal of subjectivity with respect to what is meant by a "meaningful
difference" between a prescription product and an OTC product. This codification should go beyond
simple differences (e.g., strength, dosage) and require that clinical trials form the basis for any OTC
branding - in order to ensure the safety of the population or any subpopulation for which the OTC version
is being made available.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1>Yes - to a degree. <4: 4.3.4>The interpretation is sound. However, there is confusion
due to the lack of a documented "decision tree" around the process of FDA approval for the sale of an
OTC product.
C. If so, would a rulemaking on this issue help dispet that confusion?
<5: 5.1>Yes. <6: 5.3.2>Document the "meaningful difference" for drug manufacturers and
consumers. This will diffuse the effects of marketing, advertising, and labels that can be highly
misleading. Men and women deserve to know the truth about drugs being marketed to them.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<7: 6.3.5>The answer would clearly depend on how the subpopulation was classified. Age restrictions,
for example, could be enforced as a matter of law.
B. If it could, would it be able to do so as practical matter and, if so, how?
<8: 7.1, 7.4.4>Yes. Minors are not permitted to buy alcohol without proper ID showing proof of age.
COMMENT NUMBER - 2005N-0345-EC5
2005N-0345-EC5 - STRUCTURED DATA ELEMENTS
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Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Cunningham, Laura
2005N-0345-EC5 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>YES
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
YES
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>YES
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>YES
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 7.1, 7.4.4>YES, BY MAKING STORES CHECK IDENTIFICATION BEFORE PURCHASE, JUST
AS THEY DO WITH CIGARETTES AND ALCOLHOL. CASH REGESTERS AUTOMATICALLY
STOP A SALE AND ASK FOR THE CUSTOMERS DATE OF BIRTH. <5:
7.4.1>PUTTING THEM BEHIND A PHARMACY COUNTER WOULD MAKE THEM AS
INACESSABLE THEY WERE BEFORE BECAUSE PHARMACISTS WOULD THEN NOT
DISTRIBUTE THEM DUE TO RELIGIOUS BELIFES.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.4.4>BY MAKING CASH REGISTERS CHECK DATE OF BIRTH
3
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A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1, 8.3.4>YES,WITH A DISCLOSURE
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.1.1>IF THERE WAS A DIFFERENCE IN PRODUCT INGREDIENTS
GENERAL
GENERAL
<9: 1.2.1>PUT THIS PRODUCT ON THE SHELF SO WOMEN MAY DECIDE FOR THEMSEVES
WHAT IS RIGHT FOR THEM.
COMMENT NUMBER - 2005N-0345-EC505
2005N-0345-EC505 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Padden, Phillip
2005N-0345-EC505 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.7.1>Check your congressional mandate. If it requires that interpretations be justified then yes,
codifying your interpretation would be an extension of justification.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Again, Check your congressional mandate. If it requires that interpretations be justified then yes,
codifying your interpretation would be an extension of justification.
2
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A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.2, 6.5.4>No, but as a matter of law all America's should have equal access to drugs without any
government restrictions/prohabitions. The constitutions allows for the regulation of interstate trade, not
the restriction of it.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.1, 7.4.4>Yes, follow the example of alchol and tobacco age restrictions.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.1>Yes
GENERAL
GENERAL
<5: 1.2.1>The release of Plan B as an OTC, should not be held up or restricted, of a young woman's
access to the drug.
COMMENT NUMBER - 2005N-0345-EC516
2005N-0345-EC516 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Katrib, Elise
2005N-0345-EC516 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.2>Yes it should allow Plan B to be available both in prescription and OTC drug form. But given
that the pharmacists are allowed to choose which prescription you are allowed to receive, the OTC drug
should marketed heavily.
1.
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 1.2.2>As long as the active ingredient is safe, market in both a prescription drug product and an OTC
drug product.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1, 4.5>Yes, it seems that given enough pressure or money, a drug will be able to overcome FDA
interpretation of any act.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 3.8.3>The rulemaking should focus on safety. But also take into account that the same drug is widely
available in other countries such as Canada and the Britain.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.1>Yes it is possible to sell to a subpopulation.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 6.6.3, 7.4.4>How do we enforce the sale of tobacco and alcohol? Just check ID.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1>Yes
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.2.1>They may be sold in a single package if they have the same active ingredients.
GENERAL
GENERAL
<9: 1.2.1>I support the OTC version of the Plan B drug. I am actually surprised that the FDA is taking a
longer time to examine this drug then others that have been declared safe to be sold as OTC drugs. I
believe that the Plan B drug sold as an OTC will resolve many instances of conflict in pharmacies,
regarding the right to have a valid prescription filled. I will keep checking for updates regarding this
issue.
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COMMENT NUMBER - 2005N-0345-EC518
2005N-0345-EC518 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kowalczyk, Brigid
2005N-0345-EC518 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.3>The morning after pill, which is potentially an abortifacent drug, should not be sold over the
counter to anyone. It is a serious drug with a serious use that should not be trivialized by selling it to
anyone who thinks they need it. There is no way to limit its application and avoid abuses which will be
very damaging to the health of the women who take it as well as potentially causing an abortion, which is
its only intent.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 1.2.3>the active ingredient in the morning after pill should not be allowed to be sold over the counter
for any reason. If it is available by prescription there is some control over who decides to take it, some
oversight to the application. OTC drugs can be and will be abused and used incorrectly often.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1>there is significan confusion. <4: 4.5>No drug should be sold both by prescription and
OTC.
C. If so, would a rulemaking on this issue help dispet that confusion?
<5: 5.1>Yes.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<6: 1.2.3>How could that work? What subpopulation? Who decides who that "subpopulation" is? Only
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prostitutes? Only teenagers under the age of 18? Only women between 18-24? Ridiculous. The decision
to us MAP is a decision to take a drug to eliminate a condition. That condition is merely pregnancy, a
normal natural consequence of intercourse. We do not recommend laxatives and bulimia and extreme
exercise for overweight people who are also suffering the consequences of their act of eating, too much or
the wrong things. But those items (laxatives) can be abused becasue they are OTC and we have no
control over them. But that person is only hurting themselves. Someone who takes an OTC MAP will be
hurting themselves and also removing a conceived embryo from the planet. This hurts the child (embryo
is a child) and the planet and the effects of the OTC hormone will also hurt the woman who takes it.
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 1.2.3>I answer questions, on a website, that come from young women who "accidently" have sex
with someone and not knowing where they are in their cycle or how likely it is that pregnancy could
result, ask me if they should get MAP. And then if they "accidently" do it again 2 or 5 days later, they ask
the same question again! So many women, because they are scared (and doing the wrong thing) are going
to think this saves them. They are going to think they are safe if they just do whatever they want and then
take the MAP, especially if it's available OTC.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 8.2, 8.6.4>How confusing is that? One girl goes to her doctor and gets a prescription, the other goes
to the local drug store and picks up the same box! One girl has some medical supervision in case there are
adverse reactions (abortion is an adverse reaction but that won't be considered) and the other is on her
own to consider her symptoms without any medical opinion to guide her. That's a good idea! NOT.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<9: 9.1.2>All circumstances. Neither should be sold but if it will be sold and marketed (that's where the
problem comes) then it should be something that women consider to be a serious drug with serious side
effects, not something like Sudafed or antacids that anyone can pick up at any time without a medical
diagnosis!
COMMENT NUMBER - 2005N-0345-EC52
2005N-0345-EC52 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Zahn, Steven
2005N-0345-EC52 - TEXT
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1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes. <3: 4.5>It is not significant enough that different strengths of the same product are
marketed as prescription or OTC. That gives the illusion of safety in taking increased doses of the OTC
product knowing that there is an equivalent prescription dose available.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 6.1>Yes.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.2>No, not under the current regulations and its interpretations.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2>No. <7: 8.6.2>There would be too much confusion among packaging, leading too errors
in dispensing the wrong products or packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.1.2>All circumstances. The OTC product would have the same potential for harm from misuse, or
circumstances surrounding its use, in one subpopulation as in another.
GENERAL
GENERAL
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<9: 3.11>It is not significant enough that different strengths of the same product are marketed as
prescription or OTC. That gives the illusion of safety in taking increased doses of the OTC product
knowing that there is an equivalent prescription dose available. The safety of all market strengths
available of a particular product should be considered when evaluating a product's safety for OTC use.
Also, limiting OTC sales of a product to population subgroups still exposes that subpopulation to possible
harmful effects or cirucmstances due to misuse of the product. Potentiality of harmful effect of a product
can also be realised from the circumstances in which a product is used, and not just toxicities from the
product itself.
COMMENT NUMBER - 2005N-0345-EC522
2005N-0345-EC522 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dolinski, Elizabeth
2005N-0345-EC522 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.2, 3.2, 3.8.8>The FDA should only rule on drug safety issues. I am very upset that the FDA is
trying to pass moral judgement on the U.S. population. It has been determined to be medically preferable
to make plan b available simultaneously available. Therefore, that is what the FDA should do.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
The FDA should only rule on drug safety issues. I am very upset that the FDA is trying to pass moral
judgement on the U.S. population. It has been determined to be medically preferable to make plan b
available simultaneously available. Therefore, that is what the FDA should do.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.3.2>the FDA CAN make a drug both prescription and over the counter. That is clear to me and
should be made clear to the public.
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C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.5>the FDA CAN make a drug both prescription and over the counter. That is clear to me and should
be made clear to the public.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.7>the FDA has no right to make an OTC drug available only to a subpopulation. The only
subpopulation separate the FDA has a right to regulate is minor versus adult.
B. If it could, would it be able to do so as practical matter and, if so, how?
The only subpopulation separate the FDA has a right to regulate is minor versus adult.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.1>YES, of course. <6: 8.4.1>To require different packaging would raise the price for no
good purpose.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 8.7, 9.1.1>For the same dose, it should always be appropriate. The ONLY reason it wouldn't be
appropriate was if higher dosages were to be prescription. I.e. for ibruprofen.
GENERAL
GENERAL
<8: 1.2.2, 2.1>I am deeply offended by the delay of approval of plan b. Why would the FDA want to take
action that drives up the number of risky operations (abortions) for young women? especially when there
is a safe contreceptive alternative? does the FDA intend to purposefully injure young women with this
action?
COMMENT NUMBER - 2005N-0345-EC526
2005N-0345-EC526 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Thompson, Sharon
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2005N-0345-EC526 - TEXT
Issue Areas/Comments
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 6.2, 7.5.3>It would not be possible to regulate having "prescription" status for a particular
subpopulation because it would be too easy to circumvent this.
B. If it could, would it be able to do so as practical matter and, if so, how?
<2: 7.4.1, 7.5.3>It would need to be "behind the counter" in pharmacies, and pharmacists would need to
regulate. However, even this seems like it would be easy to circumvent if something is a prescription item
just for certain subpopulations. <3: 7.4.6>For any subpopulation that is a minor, I would
think a signature of a legal guardian would be necessary.
GENERAL
GENERAL
<4: 2.1>I would hope the FDA would never sacrifice safety for convenience. It seems like there is quite a
push for convenience over safety, and my hope is that the FDA won't cave to the pressure.
COMMENT NUMBER - 2005N-0345-EC527
2005N-0345-EC527 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ramirez, Robert
2005N-0345-EC527 - TEXT
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.3>Yes, if clarification is needed iniate a rulemaking interpretation. If a active ingredient
scientifically shows that is safe and effective for the public and the only reason for the product not being
available for the public is red-tape, then policy has to be amended.
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1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.3.2>If an active ingredient is proven scientifically that it is safe for public use in the same dosage
there should not be any difference. Make the product OTC. If needed for clarification codify the
ingredients and list them for dual markets.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.2>No. One this would be a enforcement nightmare. <4: 1.2>Codify the active ingredients
or have a resubmittal of the application and have physical developement and size as the criteria for dosage
for effectiveness.
GENERAL
GENERAL
<5: 1.2>Fundamental there is an age limit on the initial inital application. Does the scientific evidence
show significant differences with regards to age? This should be the question. If not have the application
resubmitted without age and included individual physical development and size.
COMMENT NUMBER - 2005N-0345-EC53
2005N-0345-EC53 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: McGhee, Tim
2005N-0345-EC53 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
It's very unclear to me how OTC status would not render completely irrelevant a drug's prescription
status--especially when it's the same drug.
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1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 4.3.4>It's very unclear to me how OTC status would not render completely irrelevant a drug's
prescription status--especially when it's the same drug.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes, the FDA's interpretation would create legal confusion. <3: 7.5.3>That said, young
people today are bright and would quickly figure out a way around the system/confusion. We don't need a
second-tier market of these pills between younger and older teenagers.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.2>I find this to be unlikely.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 7.5.3>As I mentioned in response to 1B, there would be no limitation. The FDA is trying to parse out
a particular subpopulation into segments which are inherently fluid--teenage girls. Saying 15-year-olds
need a prescription, and 16-year-olds don't?
The FDA may find it needs to draw an imaginary line dividing the two, but that line would not extend
very far beyond the confines of the FDA into reality.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.2>I do not believe it could.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.9>The package doesn't change the contents, but it might change who is more likely to obtain the
drug.
The tobacco industry was blasted for using "Joe Camel" that attracted young people to smoking. The
moral of the story here is, changing the packaging would only increase who is likely to get the drug, not
limit young people from getting the drug.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
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<8: 9.2.1>Let's say the drug maker gets a green like to market the hell out of this drug--specifically for the
16-year-old girls and up market.
Continuing with the Joe Camel analogy, if they market the drug in areas to reach girls significantly under
the specified age (such as 13, 14, 15), then the packaging in the marketing should match the prescription
packaging, not the OTC packaging.
GENERAL
GENERAL
<9: 1.2.4>I don't believe this drug should be on the market at all.
As we have discussed in the cloning and embryonic stem cells debates, the union of egg and sperm is the
beginning of life. I began there; we all began there.
This drug specifically thwarts the ability of that newly formed life from becoming the person God created
them to be. This drug prevents the essential implantation of that life into the woman's body. That's killing
it.
The use of this drug is wrong, and should not be endorsed by the FDA.
Thank you for your time, and for allowing me to speak.
Tim
COMMENT NUMBER - 2005N-0345-EC535
2005N-0345-EC535 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rectenwald, Theodore
2005N-0345-EC535 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes. <2: 3.8.1>Clarity is necessary.
1.
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B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>No.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1>Yes. <5: 6.6.3>This is already done, for instance, with tobacco and alcohol.
<6: 1.2.3, 6.5.4>In the case of the abortifacient "morning-after-pill," direct OTC sales to minors without
parental consent runs counter to every medical ethic currently practiced. Indeed, public health authorities
will not even administer government-mandated immunizations without parental consent. To treat this
matter differently would not only offer an absurd exception, but also engender a serious violation of
parental rights and amount to an invansion of family privacy.
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 6.6.3, 7.1>Yes, in the same manner as sales of tobacco and alcohol are controlled. <8:
1.2.3>On the other hand, kindly note that I am opposed to making this particular drug available in any but
prescription form, if at all. It is dangerous and should not be available at all, let alone without a
prescription.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<9: 9.3>On the (false) assumption that it should be legal, the packaging would be irrelevant.
<10: 8.2, 8.5.4>However, differences in packaging would make control of violations (sales to minors, for
instance) easier to detect and, perhaps, prosecute.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
Same as above.
GENERAL
GENERAL
<11: 1.2.3>I am vehemently opposed to the availability of this abortifacient in general but, in view of the
FDA's acceptance of it, would at least like to ensure that it continues to be accessible only by prescription.
If this dangerous drug is foolhardily to be made available OTC, at a minimum access for minors ought to
be restricted by the need for a prescription.
COMMENT NUMBER - 2005N-0345-EC54
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2005N-0345-EC54 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rommel, Scott
2005N-0345-EC54 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.1>Yes, this would seem to be a required point considering the amount of drug therapies
available and the numders will only increase. In addition, when ever there are regulatory vagaries groups
seems to always take advantage and promote unintended agendas.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes, see above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>Yes.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 3.8.7, 6.2>NO, This seems to be a problem waiting for a whole lot of money to be waisted on. Either
a drug is over the counter or it is not.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2, 7.4.1, 7.4.4>Most likly not, the only practicle level of screening that may work is to have a drug
OTC, but behind the counter where an ID is the only questioning limiting the drugs despensing.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2, 8.6.4>This would seem to be a problem waiting to happen. If this is to occur then the two
packages should be different. It does not seem reasonable to require a possible enforcement protocol to
account for an item with the same packaging with one being legal OTC and the other not.
<7: 3.8.7>Either trust the majority of the population to do right and keep it all OTC or distrust and try to
manage the minority and keep products behind a counter under strict control, both will have good and bad
social consequences but one will cost more.
COMMENT NUMBER - 2005N-0345-EC555
2005N-0345-EC555 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Della Paolera, Mark
2005N-0345-EC555 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
No.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.2>No.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No.
2
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A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.2>NO, the FDA cannot guarantee that such age restrictions would be satisfied. <4:
7.5.3>Underage patients would still have access to the drug whether it is other persons of age purchasing
it for them, theft, or cashiers selling it without certifying a person's age. <5: 1.2.3>Plan B
needs to remain behind the counter.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2, 8.6.4>NO, confusion could occur with stocking issues. When a shipment of Plan B arrives, is it
stocked in the front end of the store or in the pharmacy? Separate packaging is necessary.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 7.4.1, 9.2.2>There is none. It needs to remain behind the counter.
GENERAL
GENERAL
<8: 1.2.3>The marketing and selling of Plan B as an OTC product is a terrible idea. The general
population need to have a greater understanding of the drug and granting it an OTC status revokes the
importance of its use, how it is used, and how it acts to the consumer. There needs to remain a patient-
healthcare professional relationship. Often when a product is granted OTC status, the public's perception
is that the intervention of a healthcare provider is not necessary. Placing Plan B OTC prevents important
aspects that need to be addressed to the patient. One such example is notifying patients of its mechanism
of action. Many do not know that it prevents a fertilized egg from adhering to the endometrium and often
choose to not perform this method of 'contraception' as they would view this as an abortion. Patients also
need to be informed on potential side effects and need to guarantee that the patient is using it within 72
hours. When a product goes OTC, many patients will use a product against the manufacturer's
recommendation. Having a pharmacist involved can help prevent such complications. Furthermore, the
phrase 'emergency contraception' is a misnomer to many patients who may believe this is an item that
could be taking regularly prior to each act of coitus. i.e., the public needs to know that there are safer and
more effective means of contraception than purchasing Plan B. <9: 7.5.3>One final aspect to
consider is that no one could guarantee that children under 16 would not have access to the drug. Cashiers
could unknowing sell it to an underage person, it could be stolen, and it could be purchased by a person of
age and given to the underage child. <10: 1.2.3>In summary, Plan B needs to remain behind
the counter to protect the safety of patients by maintaining a patient-provider relationship.
COMMENT NUMBER - 2005N-0345-EC56
2005N-0345-EC56 - STRUCTURED DATA ELEMENTS
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Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Porter, Rebecca
2005N-0345-EC56 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No.<2: 3.8.8> If the medication is not safe enough for OTC use then it should be sold
only by prescription to maintain the safety for all parties. Making it OTC will make it available to the
group for whom it is not acceptably safe. <3: 3.3.3, 7.5.3>There is too great a potential for this
drug to be abused. There is more to this issue than carding the patient. Fake ids are easily found. Who will
monitor these patients that are taking the prescription? Medications that are taken OTC are expected to be
safe and not need a doctor's follow up.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No. There is too great of a potential for this drug to be abused and lives to be put into danger. <4:
1.2.3>The use of this medication should be monitored by a responsible physician only.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.2>No. <6: 6.6.3, 7.5.3>Look at the amount of alcohol that is sold to minors. There will
always be a way for the underaged to get this medications.
COMMENT NUMBER - 2005N-0345-EC566
2005N-0345-EC566 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Burgess, Annette
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2005N-0345-EC566 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
No.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.2>No.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>No. <4: 1.2.3>There is a secondary danger of allowing this drug to go into an over-the-
counter class. If this pill were allowed to become an over-the- counter medication, it could deny a woman
the safety of conversing with her doctor the medical risks of taking it, deny the woman the privacy of
deciding if she wanted to take the prescription or not, and might allow the woman's mate to buy the drug
and coerce her to take it against her wishes, her health or that of her unborn child. To change this
interpretation would not allow a woman to have a witness (i.e., the doctor who would writes the
prescription) that she indeed did ask for this drug. Changing this drug's designation to Over-the-counter,
would not give the woman the privacy to make her own choice in whether this drug was too dangerous to
her health or not. <5: 6.5.4>To change the interpretation might bring legal consequences upon
the FDA or the stores selling this drug if a wrongful death suit were initiated.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<6: 6.2>No. <7: 6.5.4>What would be legal consequences in a wrongful death suit to the FDA
and the stores who carry this OTC medication? <8: 3.8.7>A subpopulation ruling would open
a pandora's box to all kinds of hybrid requests that would tie up government as well as be a financial
burden on stores which carried such products as they'd have to hire additional employees, etc. in an
already stressful environment to provide timely prescriptions. Talk about back-log!
B. If it could, would it be able to do so as practical matter and, if so, how?
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<9: 7.2>It couldn't. This would open the door to all kinds of age-related or hybrid
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<10: 8.2, 8.6.4>No, because of the harmful side effects of this drug.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<11: 8.2>It should not be legal.
GENERAL
GENERAL
There is a secondary danger of allowing this drug to go into an over-the-counter class. If this pill were
allowed to become an over-the-counter medication, it could deny a woman the safety of conversing with
her doctor the medical risks of taking it, deny the woman the privacy of deciding if she wanted to take the
prescription or not, and might allow the woman's mate to buy the drug and coerce her to take it against
her wishes, her health or that of her unborn child. To change this interpretation would not allow a woman
to have a witness (i.e., the doctor who would writes the prescription) that she indeed did ask for this drug.
Changing this drug's designation to Over-the-counter, would not give the woman the privacy to make her
own choice in whether this drug was too dangerous to her health or not. To change the interpretation
might bring legal consequences upon the FDA or the stores selling this drug if a wrongful death suit were
initiated.
No. What would be legal consequences in a wrongful death suit to the FDA and the stores who carry this
OTC medication? A subpopulation ruling would open a pandora's box to all kinds of hybrid requests that
would tie up government as well as be a financial burden on stores which carried such products as they'd
have to hire additional employees, etc. in an already stressful environment to provide timely prescriptions.
Talk about back-log!
COMMENT NUMBER - 2005N-0345-EC569
2005N-0345-EC569 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Tansley, Kathleen
2005N-0345-EC569 - TEXT
Issue Areas/Comments
1
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>I feel strongly that the FDA should not initiate a rulemaking to codify their interpretation of
section 503(b), about duel-marketing both a prescription drug product and simultaneously an OTC
product.
<2: 1.2.3>Making Plan B over the counter would create numerous problems especially with regard to
keeping it out of the hands of minors. <3: 7.5.2, 7.5.3>The FDA has no mechanism for
enforcing a regulation that prohibits sale to minors. And enforcing this could not only cause serious
controversy on both sides of the spectrum, but be very difficult to regulate.
I feel the FDA should step back and realize this, and not go further with this type of policy change.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<4: 4.2>I myself, am not confused by 503(b) as explained on your web site here. <5: 3.8.8>But I
have written my serious concerns above (see A), and see no logical reason for the FDA to change their
policy on this issue, it would create serious controversay, difficulty, and perhaps even future lawsuits
from consumers at the extreme.
C. If so, would a rulemaking on this issue help dispet that confusion?
<6: 3.2, 3.8.8>I believe the rulemaking should stay as it is. And not go change policy, allowing duel-
marketing of both a prescription drug product and simultaneously an OTC product. The FDA should
remain firm on this issue in this regard.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<7: 6.2, 6.5.4, 7.5.3>Selective limitation of a product to a sub-population could bring on lawsuits from
either end of the spectrum from disgruntled consumers, as well as media controversy on the issue, and a
near insurmountable impossibilty to enforce such a regulation.
This is a bad idea for the FDA to pursue.
B. If it could, would it be able to do so as practical matter and, if so, how?
<8: 7.2>No. I cannot see this happening.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
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the different products be legally sold in the same package?
<9: 3.8.5>This again would be a cause for concern for the consumers, and controversy could arise, and
laws must be changed, and I feel this is incorrect to do a 'blanket change of policy for reinforcement on
duel-marketing drugs' in this manner.
What if other drugs arise in the future and likewise the drug companies suppling the consumers would
want the same option, and what if there is cause for concern that this would be detrimental to the
consumers by doing this? The FDA would then have to do 'damage control' and back-pedal on their
policy on rulemaking if they follow this route.
COMMENT NUMBER - 2005N-0345-EC572
2005N-0345-EC572 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Naughton, John
2005N-0345-EC572 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.3>Why approve OTC use of a drug which is generally ineffective?
Morning-after pill access fails to cut pregnancy rate - January 5, 2005
By Cheryl Wetzstein
THE WASHINGTON TIMES
<2: 1.2.3>Women's health care advocates have been urging the federal government to allow easy access
to "morning-after" pills as a way to dramatically reduce unintended pregnancies. However, a study
released today undercuts that argument by showing that young sexually active women who were handed
packages of "morning- after" pills had pregnancy rates six months later that were virtually the same as
women who had to go to drugstores or clinics to get the pills. "That was definitely a disappointing
finding," said Tina R. Raine, lead researcher of the study of 2,117 women, which appears in today's
Journal of the American Medical Association (JAMA). A core hypothesis, she said, was that two groups
of women with easy access to "emergency contraception" (EC) would have half as many pregnancies as
women who had to see a health provider to get the pills. Instead, all three groups of women had
pregnancy rates of around 8 percent. Nevertheless, EC should still be available without a prescription,
said Dr. Raine, a professor at the University of California at San Francisco. That's because the study also
showed that when women had easy access to EC, they used the pills more often, but they didn't take more
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sexual risks or get more sexually transmitted diseases (STDs), as some have feared. Given these findings,
"it seems unreasonable to restrict access to EC to clinics," Dr. Raine and her colleagues wrote. Concerned
Women for America analyst Wendy Wright, an opponent of EC, disagreed. "Why make [EC] easily
available and put women's health at risk if it doesn't even reduce what the women fear, which is
pregnancy?" she said. Emergency contraception refers to high-dose birth-control pills taken within 72
hours of unprotected sexual intercourse. The pills, used by 4 percent of women, can interrupt ovulation,
fertilization or implantation. All but six states require a prescription to get EC. Most women's health
advocates believe that half of the nation's estimated 3.5 million unintended pregnancies could be
prevented if EC were widely available, especially to teens and college-age women. They believe the pills
are safe and effective, and they have launched campaigns urging the federal Food and Drug
Administration (FDA) to allow the nation's primary EC product, Plan B, owned by Barr Pharmaceuticals
Inc., to be sold without a prescription. Opponents of EC, such as Miss Wright, worry that easy access to
EC will encourage irresponsible sexual behavior and STDs.
Studies of EC in Britain show easy access to the pills causes "an increase in STDs and no decrease in the
number of abortions," she said. In 2003, two FDA advisory panels recommended that the FDA approve
Plan B for over-the-counter sales, but in May, the FDA declined, saying it was concerned about teens
using the product without medical supervision. A spokeswoman for Barr Pharmaceuticals yesterday said
they have resubmitted Plan B paperwork and are expecting another FDA response this month. The Raine
study, conducted between 2001 and 2003, divided 2,117 sexually active women, aged 15 to 24, into three
groups. One group received free packages of Plan B, another group was told how to get Plan B for free at
drugstores and a third group was told how to get Plan B by appointment from a health clinic. A key
hypothesis was that, six months later, women in the two groups with the easiest access to EC would have
5 percent pregnancy rates, compared with a 10 percent pregnancy rate expected for women who had to go
to a clinic to get Plan B. But the three groups still got pregnant at about the same rate: Eight percent of the
women with Plan B at home became pregnant, as did 7.1 percent of women with "pharmacy access" and
8.7 percent of women with "clinic access."
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<3: 1.2.3>Why approve OTC use of a drug which increases the risk to women's health - abortion?
Nonprescription EC Linked to Rise, Not Drop, in Abortion Rates --Yet Advocates Continue to Push for
Over-the-Counter Sales
Newly published figures on the number of abortions taking place in Britain show that the abortion rate
has increased despite the availability of so- called "emergency contraception" (or, as critics call it, the
"morning after abortion pill") which can be purchased without a prescription. The abortion rate has
increased each year since Britain introduced nonprescription EC in Jan. 2001, with 2.1 percent more
abortions taking place in England and Wales in 2004 than in 2003. EC is a high dose of contraceptive
hormones that can act as an abortifacient if the woman has already conceived. U.S. abortion advocates
have claimed that it will reduce the abortion rate by half. However, studies in Scotland and the U.S.
(including a study of more than 2,000 young women that was published in the Journal of the American
Medical Association this past January) have shown that selling EC over the counter has not reduced
pregnancy and abortion rates, even when women are given the drugs in advance and are therefore more
likely to use it. In addition, the teen pregnancy rate increased 31 percent in Sweden after nonprescription
EC became available there. While abortion advocates have claimed that the rise in abortion rates in
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Britain is due to other factors, critics say EC leads people to engage in more risky sexual behavior
because they falsely think they are protected from pregnancy, leading to higher rates of unintended
pregnancies, abortions, and sexually transmitted diseases. In addition, EC does not abort ectopic
pregnancies and therefore women who use it may not realize they are still pregnant, putting their health
and lives at risk.
The new figures come as the Food and Drug Administration announced it is delaying a decision on
whether it will allow nonprescription EC sales in the U.S, citing a lack of data on the drugs' effect on
teens and an inability to enforce regulations limiting nonprescription sales to women over the age of 17.
Seven states currently allow nonprescription EC sales. Barr Laboratories, which markets EC under the
name "Plan B" says it is planning to urge other states to allow the sales. The Planned Parenthood
Federation of America has also said it will file a lawsuit against the FDA if over-the- counter EC sales are
not approved. According to memos released as part of a lawsuit filed against Planned Parenthood in
California, the organization stands to make considerable profit from over-the-counter sales of EC because
of a deal the group struck with Barr allowing them to purchase the EC kits at a price below that of other
retailers. Planned Parenthood's price on the EC kits averages below that of the competition, and Planned
Parenthood watchdog group STOPP, the organization could make $100 million or more in profits over
the next five years if EC was made available over the counter.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No comment
C. If so, would a rulemaking on this issue help dispet that confusion?
No comment
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
No comment.
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.2>Absolutely not. <5: 7.5.3>Older teens will buy the pills for younger teens.
COMMENT NUMBER - 2005N-0345-EC58
2005N-0345-EC58 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Venturella, Vincent
2005N-0345-EC58 - TEXT
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Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No. <2: 3.8.4>There is no need to initiate any further rulemaking for codification of the
action. It is quite clear in its present form.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No I believe the FDA's interpretation of the formal act for distinguishing the 2 parts of the isssue needs no
further clarification,
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>There is no confusion as I read Commissioner Crawford's thinking on the manner that the
decision and/or interpretation that needs to be encompassed.
C. If so, would a rulemaking on this issue help dispet that confusion?
N/A
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1, 6.3.2>I do not see any deviation from the law(s) available to the FDA under the current FD&C
Act that would prevent it from instituting this policy.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.4.6, 7.5.3>As a practical matter, I do not envision an easy way to do this specifically for Plan B. It
might be possible if the OTC portion was transacted in the manner that some exempt narcotics were
handled in the periods prior to the 80s, when simple ledgers were kept for limited portions of the sale of
exempts during a narrow window of time. However, as was obvious then, the signer was not always the
subject end user and there was no proof that the dispensing act was aimed at the correct age group or
ultimate patient.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
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the different products be legally sold in the same package?
<6: 8.2>No. <7: 8.6.3>There must be a distinguishing characteristic to provide for a value
product. Same packaging would permit (and usually tempt) facile trading or swapping, defeating the
original purpose of dual (dispensed) products.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.1.1>When one cannot be secure in the knowledge that the "Prescription Only" product will be
available to only the restricted group.
GENERAL
GENERAL
<9: 1.2.3>I believe that the product known as Plan B should be for Prescription Use only (if used at all)
so that it cannot be available to any consumer under the age of 17. I further believe this is the only
rational approach given the data available. The 48-72 hour use limit for effectiveness can, I believe, be
adequately handled in those situations that are truely emergency events by access to any of the "24 hour"
local facilities that exist in most all communities.
COMMENT NUMBER - 2005N-0345-EC586
2005N-0345-EC586 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Doran, Gregory
2005N-0345-EC586 - TEXT
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 6.2>No. <2: 7.5.3>You would NOT be able to inforce or prevent the illegal usage until the
persons are injured by its usage. Let alone even for a 17 year old consumer may not be sufficiently
informed of the risks of the drug. The greater fear is anyone using the drug without sufficient knowledge
of the risks of the drug including the psychological predisposition (desperation) and postdisposition
(negative side affects). Requiring a prescription will require the patient to confront their physician for
advice and allow the physiscian to properly educate the patient on its safe usage if it is safe for that
patient.
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COMMENT NUMBER - 2005N-0345-EC59
2005N-0345-EC59 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Leonard, Ruth Tehila
2005N-0345-EC59 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>I don't quite understand this question, but if you mean should you set a standard whether or not a
product with the same active engredient can be sold on and off the counter simultaneously I think the
answer is yes.<2: 3.3.2, 4.3.4> I can see no reason why an identical product will have to be
given by perscription for one person and free for purchase to another. I suggest you allow certain people
to carry open perscriptions for products they need regularly for a particular medical condition, but
otherwise substances with the same active engredients in the same doses that you do not deem safe for the
entire population should not be sold to one segment over-the-counter and to another as a perscription. <3: 1.2>Another issue that seems to loom large is that if you decide to allow this particular
drug to function in both over-the-counter and prescription mode, what reason is there to keep regular
contraceptive pills - that are a third as powerful as these similar drugs - from being approved for the same
sale? I don't understand the logic here.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 7.5.3>I can only tell you from what we see here in Israel - where the morning-after pill is sold over
the counter - that there is no way to control who buys it. I work with organizations that council teens and
many middle-school and high-school students are saying that they now use the morning-after- pill as a
contraceptive since they do not need a perscription or parental consent to purchase it. A quick cursery
jaunt into chat rooms specific to teen issues in Israel shows this is a rather popular view of the new
solution to free sex. <5: 1.2.3>Many teens panic and take the morning-after pills (there are
three you take in a row, I believe) twice or more in one cycle. How will you control this when you sell
them over the counter? With a prescription medicine there is at least some control over how often the
patient has access to a potentially damaging drug. <6: 7.5.3>I have also been in supermarkets
to buy wine and the cashiers have not asked for ID though I am young and could be mistaken for someone
under 21. Over-the-counter meds will get even less attention from a teenage cashier.
B. If it could, would it be able to do so as practical matter and, if so, how?
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<7: 7.2, 7.5.3>I don't believe there is an effective way of controlling over-the-counter med sales unless
you can control who mans the cash-register. As you know, this is impossible.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 7.5.3>Why bother with making one prescription? Will a 13 year old not simply ask her older sister or
friend to buy her the pills? If the packaging is the same, wh
GENERAL
GENERAL
<9: 1.2.3>Giving anyone hormonal treatments without strict medical supervision seems foolhardy and
dangerous to me. <10: 1.3>Especially in light of recent deaths from unsupervised use of
RU486 pills.
COMMENT NUMBER - 2005N-0345-EC6
2005N-0345-EC6 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Goodman, Evan
2005N-0345-EC6 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
If we assume that Plan B has not been shown to be safe without prescription for children under 17, then
the new regulations should be considered. A drug that can be very helpful to women and is only denied
based on ideaology instead of science should be made available by any truly scientific health
organization.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
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<1: 3.1, 3.8.3>If we assume that Plan B has not been shown to be safe without prescription for children
under 17, then the new regulations should be considered. A drug that can be very helpful to women and is
only denied based on ideaology instead of science should be made available by any truly scientific health
organization.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 3.9.1, 4.2, 7.5.3>I am not aware of confusion within the act; however, I do know that other drugs are
over-the-counter and prescription when used in different ways. In doing that, it seems far less easy to
regulate a drug that can be bought over the counter by anyone for the prescription use as long as they
know what prescription drug it corresponds to. <3: 6.6.3>By allowing a drug to
have an age restriction, if it is truly based on health issues, the drug can be regulated in much the same
way as tobacco and alcohol.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.1, 5.3.2>If there is confusion on any issue, wouldn't making a rule to dispell the confusion take it
away. I don't believe this question is even worth asking.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.1, 6.6.3>Regulations based on age have existed in this country since it's onset. Voting was the first
restriction, tobacco and alcohol have legal ages for purchase at stores across the country.
<6: 7.4.4>In the same store as a pharmacy, often beer is sold and so are cigarettes. Both of those require
the vendor to check ID. Plan B could easily impliment this precaution, and if making a box say must
check ID on it isn't enough, the barcode could make the register beep to check ID and have the cashier
have to push a button if the ID has been checked.
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 6.6.3>Similar methods to alcohol and tobacco could easily be used to regulate the sale of drugs. <8: 7.4.6>The box could have obvious differences such as labelling and shape to make sure the
cashier realizes that he has to check ID. <9: 7.4.4>Furthermore, as implemented for alcohol at
some cash registers, the register itself could beep to check ID when the barcode is scanned, and the
cashier would have to check the ID before pushing a button to ok the sale.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<10: 8.9>I don't understand why it wouldn't be legal, but it may in fact, at present, not be. And, even if it
is illegal, the pharmacy could hold different packaging for the same medicine in the back as the over-the-
counter version. Again I point to tobacco and alcohol as examples of packaging restricted to younger age
groups.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
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inappropriate to do so?
<11: 8.1, 9.1.1>Prescription and non-prescription Plan B, assuming they are two products for legal
purposes, are the same exact drug and do not need different warning labels or precautions. So, it would
only be inappropriate to put them in the same package if all warnings were not on the single package and
if it did not specify the age restriction for distinguishing purposes.
GENERAL
GENERAL
<12: 1.2.1>Abortion is legal in this country, so not selling Plan B, even if it is put in the category of an
abortion drug, because abortion is morally wrong to some people would be poor judgment. This point is
especially true considering separation of church and state in addition to the privacy issues brought up by
Roe vs. Wade. <13: 6.5.4>Furthermore, the FDA is supposed to approve drugs that are found
to be safe and effective. Aspirin, for example, is safe and effective, but only for people over a certain age.
It is not safe for young people because it can cause Reye's syndrome, but is still marketed over the
counter to all age groups. So, I put it to you, if you want to be hypocritical by limiting one drug that you
claim might be dangerous to children and don't limit another known to be dangerous, say so, and give a
good reason for it. <14: 2.1>I honestly think the FDA has made a big mistake in waiting this
long, and if you are not in fact doing it for political, moral, or religious reasons, I would like a better
explaination.
COMMENT NUMBER - 2005N-0345-EC609
2005N-0345-EC609 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Billingsley, Daniel
2005N-0345-EC609 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 6.5.4>I do not believe that products should be offered in OTC as well as prescription because of the
confusion this would cause as to use and dose.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
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drug product?
I do not believe that products should be offered in OTC as well as prescription because of the confusion
this would cause as to use and dose.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>I believe there is a lot of confusion.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>I don't believe a new rulemaking on confusing rule would help. <4: 3.3.3>I just believe
if a product is safe enough to OTC then a prescription should not be required.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.2, 6.5.4>The enforcement would not fall to the FDA, it would fall on the entity selling the
product.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.2>The FDA could not enforce this limitation.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.2>What would be the distinction in product? Would this not cause more confusion?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 8.2>I don't believe the two products could be sold or packaged in a single package.
COMMENT NUMBER - 2005N-0345-EC61
2005N-0345-EC61 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Card, Alan
2005N-0345-EC61 - TEXT
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1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No. No further rulemaking is required to allow for simultaneous Rx/OTC marketing, and the
sudden question about the matter is doing a grave disservice to the FDA.<2: 2.1> It appears to
be (and, frankly, let us all admit: it is) simply a delaying tactic being employed against the Plan B
emergency contraceptive for purely political reasons. The reputation of the FDA as an unbiased arbiter,
which bases its decisions solely on scientific has suffered a terrible blow as a result of this deeply
misguided policy, and public trust in this institution is too important to be squandered.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No. No further rulemaking is required to allow for simultaneous Rx/OTC marketing, and the sudden
question about the matter is doing a grave disservice to the FDA. It appears to be (and, frankly, let us all
admit: it is) simply a delaying tactic being employed against the Plan B emergency contraceptive for
purely political reasons. The reputation of the FDA as an unbiased arbiter, which bases its decisions
solely on scientific has suffered a terrible blow as a result of this deeply misguided policy, and public
trust in this institution is too important to be squandered.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2, 4.4.2>No. If there were, it would have come up long before now.<4: 2.1> This
supposed question is obviously nothing more than a politically motivated delaying tactic, a rearguard
action of partisan politics vs science.
C. If so, would a rulemaking on this issue help dispet that confusion?
<5: 5.4.3>There is no significant confusion to be dispelled.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<6: 6.1, 6.6.3>Of course this plan would be enforceable under law, just as age restrictions on the purchase
of tobacco and alcohol are enforceable under law. The legal powers of the FDA are more than broad
enough to allow for this.
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 6.6.3, 7.1, 7.4.2>Absolutely. I would recommend the wholesale borrowing of state statutes regulating
tobacco sales as the basis for regulation and enforcement.
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3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 8.1>Certainly. There is nothing whatsoever to prevent it.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<9: 9.3>None, provided that the labeling requirements for the OTC product were the same as for the
prescription product. We thereby ensure that the consumer is, under all circumstances, guaranteed the
most complete data upon which to base his/her decisions with regard to the use of the product.
GENERAL
GENERAL
<10: 2.1>I am writing today primarily to express my deep revulsion for the politicization of the drug
regulation process I have witnessed with regard to the Plan B emergency contraceptive. Neither the
science (in the case of the first delay) nor the law (in the case of the present delay) provide any
justification whatsoever for the absolutely singular treatment this drug has received. The only POSSIBLE
reason for the continuous obstructions it has faced is that there are policy makers in the FDA who are
basing their decisions not upon what is best for the health of the American public, but upon what is best
for the political goals of the Republican Party. This subversion of an honored American institution cannot
be allowed to continue. The confidence the American people have in the FDA is based on the belief that
the agency will make the best decisions it can on the basis of the best scientific data available. It is based
on the notion that they can rely upon the FDA to examine that data WITHOUT political, religious,
personal or financial bias. It is a matter of trust... and that trust is being betrayed. I implore you, before
you do any further damage to the FDA and to the long-term health of the American public (how effective
will you be, if no one listens anymore?) to please, please, PLEASE return to making rational policy
decisions without regard to politics. <11: 1.2.1>This should have been, as they say, a 'no
brainer.' The drug is safe. It is effective. Its side effects are minimal; many other OTC drugs are more
risky than this. Move on this application. Move on it today. And make the right choice to begin rebuilding
confidence in the FDA. Thank you.
COMMENT NUMBER - 2005N-0345-EC610
2005N-0345-EC610 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Koch, Frances
2005N-0345-EC610 - TEXT
Issue Areas/Comments
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1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>I think that the FDA should make rules about when a drug can be sold as both prescription and
OTC. <2: 3.8.4>The current usage - where the molecule/drug is used for different
purposes/doses it is either prescription or OTC - seems intelligent enough. <3: 3.1>I think that
actually codifying this would be good. <4: 3.3.3, 7.5.3>Making sure that OTCs are safe enough
to be used without the supervision of a physician must continue in the interests of public safety.Studies
show that the American population routinely doubles, triples, even quadruples the recommended dosage
on OTC medications - particularly pain medications. We have seen some medications go behind the shelf
(pseudoephedrine) because of the misuse of the product. In this particular case of Plan B, it would be
VERY easy for the product to be misused (18 year old buying it for a distraught 15 year old friend).
People typically don't read instructions, they don't read warnings, they don't read about side affects. They
just want to pop a pill and make it (pain, congestion, whatever) go away. How many people with high
blood pressure will take Sudafed when the packaging says not to? At least with a prescription, the have
the chance to speak with their physician. Their physician knows what they are taking, and knows their
health history. Any medication that can cause severe reactions should be controlled. <5:
3.11>And I think that the studies for this should be conducted by someone other than the drug comapny
and that the FDA should consider the results of ALL studies on a drug BEFORE it is approved for OTC
status. Lighter doses of prescription medications as OTCs is helpful to the public and the pharmacies. But
allowing a prescription to become an OTC must be done with careful, careful consideration, and with the
EXPECTATION that the dosages available OTC will be at least doubled by the average consumer.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
This is the same as the box above - question and answer). I think that the FDA should make rules about
when a drug can be sold as both prescription and OTC. The current usage - where the molecule/drug is
used for different purposes/doses it is either prescription or OTC - seems intelligent enough. I think that
actually codifying this would be good. Making sure that OTCs are safe enough to be used without the
supervision of a physician must continue in the interests of public safety.Studies show that the American
population routinely doubles, triples, even quadruples the recommended dosage on OTC medications -
particularly pain medications. We have seen some medications go behind the shelf (pseudoephedrine)
because of the misuse of the product. In this particular case of Plan B, it would be VERY easy for the
product to be misused (18 year old buying it for a distraught 15 year old friend). People typically don't
read instructions, they don't read warnings, they don't read about side affects. They just want to pop a pill
and make it (pain, congestion, whatever) go away. How many people with high blood pressure will take
Sudafed when the packaging says not to? At least with a prescription, the have the chance to speak with
their physician. Their physician knows what they are taking, and knows their health history. Any
medication that can cause severe reactions should be controlled. And I think that the studies for this
should be conducted by someone other than the drug comapny and that the FDA should consider the
results of ALL studies on a drug BEFORE it is approved for OTC status. Lighter doses of prescription
medications as OTCs is helpful to the public and the pharmacies. But allowing a prescription to become
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an OTC must be done with careful, careful consideration, and with the EXPECTATION that the dosages
available OTC will be at least doubled by the average consumer.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<6: 4.1, 4.3.3, 4.3.4>I think that there is some confusion built into the act because it does not directly
define when a product/drug/molecule is allowed to become an OTC. And when they are allowed to
become both OTC and prescription at different usages or doses, there is still sp,e confusion about safety,
use, etc. It gives the average consumer a false sense of security that no matter how much they take, a
medication will not hurt them. The studies show that misuse and overmedication are rampant with OTCs.
I also think that considering having the same exact medication as a prescription and as an OTC is a
misinterpretation of the act.
C. If so, would a rulemaking on this issue help dispet that confusion?
<7: 5.1>I think that a more defined set of rules would help alleviate the confusion.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<8: 6.2, 6.6.3>I do not think that this would be possible. The accessibility of alcohol and cigarettes to
minors - despite strict laws on the books - shows that in practice, limitations to subpopulations is not a
practical solution. <9: 7.5.3>The ability to enforce the law would be basically non-
existant, and therefore, the hoped for protections for any subpopulation that would come through
requiring a prescription would not, for practical purposes, be in place.
B. If it could, would it be able to do so as practical matter and, if so, how?
<10: 7.2, 7.5.3>It is ludicrous, insane, unresponsible to think that this would even be practical.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<11: 8.2>NO. Again, that is totally irresponsible, insane, ludicrous. <12: 8.6.4>If you ever
actually went down that path you'd have to have some way to determine the differenct in the general
population, or you would NEVER be able to enforce the controls.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<13: 9.1.2>It would NEVER be appropriate to do so. Under ALL circumstances it should be considered
inappropriate to sell them in a single package.
GENERAL
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GENERAL
This did not show up on the next page, so I am also attaching it as a Word file.
<14: 1.2.3>All women MUST have a prescription to get birth control pills. Why would you think that
another form of birth control should be any different? This is also a pill that has had a lot of controversy
over its safety. It should NEVER be put out as an OTC. <15: 7.5.3>There is no way of
enforcing any laws that would keep an older person from giving it to a younger one that required a
prescription. <16: 3.3.3>In addition, it essentially induces an abortion - of sorts. When you
see a physician, they know your health history, they can tell you the benefits and the consequences. They
can tell you of any potential problems to look for and when to come back or go to the hospital. The
typical American does not even read the dosage information on a bottle of ibuprofen. If they hurt they
take some, if they hurt a lot, they take a handful. Americans act like every OTC is safe - no matter how
they take it or whom (age, weight, medical history, medicines being taken) they give it to. <17: 7.5.3>Putting any medication on the shelf and behind the shelf is a mistake because of the
lack of practical and EFFECTIVE enforcement (think alcohol, cigarettes and teenagers). <18:
1.2.3>Putting a medication that could cause serious side effects on the shelf is an even worse choice. I
encourage you to treat Plan B the same way you treat ALL OTHER birth control medications and leave it
as a prescription for ALL ages. <19: 4.5>And I also encourage you to clarify section 503(b)
of the act so that any OTC MUST be a "non-prescription" dose that can be taken at multiple times the
recommended dose without harm or has an alternate presentation and use (ex. Benedryl pills or Benedryl
in itch cream). And codify the act so that the same dosage of a medication cannot be BOTH prescription
and OTC. <20: 1.2.3>I encourage you to look at ALL of the studies about Plan B usage, the
increase in STDs and abortions in populations where it is easily available, and at the potential for harm in
the medication when you are trying to decide if it should be made OTC. And do NOT make your
judgements based on what other countries are doing. Many other places thought they were going to get
one type of behavior with easy access to Plan B, and they got another one entirely. And please remember
that women are usually the losers in the STD game, and where abortion or easy fixes for uneducated sex
are readily available, the STD rate goes up. You will not be doing the female population any favors by
making Plan B an OTC medication.
If you release Plan B as an OTC, you will be doing the American public, particularly the young women of
America, a great injustice.
Thank you for your time and consideration.
Signed,
A hopeful mother of 2 young girls.
COMMENT NUMBER - 2005N-0345-EC623
2005N-0345-EC623 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: DeWitte, Conrad
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2005N-0345-EC623 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.3>Yes. It would inform the voting and pharmaceutical consuming public to understand how
such decisions are analyzed and made, including the medical purpose for creating at once a controlled and
an uncontrolled distribution channel for the same product.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes. As stated above, it would inform the voting and pharmaceutical consuming public to understand how
such decisions are analyzed and made, including the medical purpose for creating at once a controlled and
an uncontrolled distribution channel for the same product.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1, 4.3.2>Yes. For the layman and even for the well-informed layman, there appears to be a non-
sensical aspect to this aspect of FDA regulations.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.3.2>Potentially, yes. The rule making language should be developed so as to inform the public and
thus strengthen understanding and public support for FDA decisions.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.6.3>This would seem to be "possible" to make this distinction and a common analogy would be the
ability to enforce laws regarding the sale of alcoholic beverages to adults but make those same products
illegal for sale to minors. <5: 7.5.3>But aside from the appearance of this possibility, the
record of thousands or millions of violations of laws prohibiting the sale of liquor to minors suggests that
in fact such limitations would be ineffective except as "political cover" for craven and unethical
governmental administrators.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.5.3>As outlined above, this would seem to be "possible" to make this distinction and a common
analogy would be the ability to enforce laws regarding the sale of alcoholic beverages to adults but make
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those same products illegal for sale to minors. But aside from the appearance of this possibility, the record
of thousands or millions of violations of laws prohibiting the sale of liquor to minors suggests that in fact
such limitations would be ineffecitve except as "political cover" for craven and unethical governmental
administrators.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.6.4>If the FDA would seek to undermine public confidence in its purpose and effectiveness then
such a plan should be pursued.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 1.2, 9.3>It would be inappropriate to sell a highly dangerous drug as an Over The Counter
formulation and such would be the case with the "morning after abortion pill." The FDA's interest in
product packaging has been historically to ensure or at least further the goal of safety (i.e. tamper
resistance, or cleanliness protection, or warning labling, or reduction of light exposure), but this question
seems entirely designed to accommodate a product marketing consideration which suggests a cavalier
attitude of FDA administrators with respect to the health safety of American consumers. Consideration of
these aspects of this issue argue for aggressive scrutiny and change in the senior administrative personnel
at FDA.
GENERAL
GENERAL
<9: 1.2.3>FDA would abandon its purpose and thus its right to exist (and thereby also its claim for public
support) by approving a drug as an OTC product which has the power and purpose of terminating an
existing human life (e.g. this is NOT preventative, but would in fact only be used if in fact the existence
of pregnancy was known for certain to exist). The formerly, Pure Food and Drug Administration was
created entirely to protect intended or potential users of pharmaceutical products. <10:
3.3.2>Only pharmaceutical products with the potential for minimal health hazard should be offered as
Over The Counter formulations. <11: 1.2.3>In this instance the proposed product poses
severe health risks including potential death for the consumer and near certain death for the intended
target of the drug. It is by definition lethal or at least potentially lethal. There is zero justification for
approving the availability of such a product in the least or essentially completely uncontrolled commercial
envronment.<12: 7.4.2> It is well known that communities supported by families all over the
nation enforce heavy guard over the potential of even common and well understood pharmceuticals which
may be administered or otherwise made available to children or minors. Aspirin is absolutely unavailable
to a child under twenty-one years of age in all of our public schools without specific control and
approval.<13: 1.2.3> The FDA discards its authority to command any respect for its
pronouncements if this powerful and absolutely dangerous drug is approved for uncontrolled distribution
(i.e. as an OTC drug) in the face of an entire nation's effort to make pharmaceuticals available only in the
most carefully controlled and well advised setting. There is no medical reason, no practical reason and no
ethical justification for approval of this proposal to make an abortion drug available Over The Counter.
Conrad J. DeWitte Fullerton, CA
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COMMENT NUMBER - 2005N-0345-EC626
2005N-0345-EC626 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Peer, Gerald
2005N-0345-EC626 - TEXT
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.1>The FDA should clearly define its policy. Its previous position, that a substance cannot be
both prescription and OTC for the same indication, is rational and defensible and should be codified.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2, 4.4.2>Not in the past. Confusion is building due to special interest pressure.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>Yes.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.6.3>With difficulty. Such a ruling places pharmacists in the same role as alcohol dealers, cigarette
sellers and pornography peddlers: limiting exposure of the young to influences that could "corrupt
youth." Why else would an age limit be imposed? And why would FDA want to approve a
drug that would "corrupt youth?"
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 6.5.1>Extension of law enforcement by FDA on the general population complicates its mission and
enlarges the obtrusive arm of government into private lives.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
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<6: 8.9>How you package this product makes little difference. Any attempt to sell the same product as
OTC and prescription makes a mockery of the prescription process.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.2.2>None
GENERAL
GENERAL
<8: 1.2.3>Plan B is a bad idea. It is, by design, a lethal drug. To make this available without prescription
cheapens the entire public safety mission of the FDA.
COMMENT NUMBER - 2005N-0345-EC65
2005N-0345-EC65 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ray, Amy
2005N-0345-EC65 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes, <2: 8.6.2>although it is dangerous to market as both OTC and prescription status
due to possible double dosing, overdosing, and lack of apropriate medical guidance regarding diagnosis
and treatment.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.2>No. <4: 7.5.3>The front line for such inforcement is pharmacists and they would not be
able to adequately recommend, dispense and monitor subpopulations without significant work
environment changes.
B. If it could, would it be able to do so as practical matter and, if so, how?
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<5: 7.2, 7.5.2, 7.5.3>It would not be practical since the paperwork, manpower and danger to the patient
being diagnosed improperly or using inappropriate doses would far outweigh the positive nature of easier
access to medication.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2>NO! <7: 8.6.2>They should be separate to avoid confusion that could lead to serious
overdose, improper usage and lack of control of health professional in recommending and dispensing
appropriate medications and doses.
GENERAL
GENERAL
<8: 1.2.3>Plan B possesses far too much risk of danger to women's health to be listed as OTC status. It is
highly irresponsible for any health professional or human being to advocate the use of medication that
may so seriously harm an individual without proper diagnosis, physical examination and properly
informed patient consent.
COMMENT NUMBER - 2005N-0345-EC654
2005N-0345-EC654 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kortebein, Peter
2005N-0345-EC654 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes, if the benefit is clearly defined to those who would benefit from such an interpretation.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 321
<2: 4.1, 4.3.4>Yes, when applied to the particular application concerning "Plan B".
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1, 5.3.2>It would help to clear up the issue regarding the controversy over age of the women and
why those older than 16 "benefit" from OTC status and those under 16 might be harmed by OTC
status.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 7.5.3>Enforcement would obviously be the main issue and should raise the question of the reality of
those doctors who would make such drugs available under pressure from parents of minor women who
may have conceived a child.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.1, 7.5.3>No, it would not be able to monitor the use of such drugs adequately as a practical
matter.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1, 8.9>It would not make a difference if the packaging contained language that indicated that two
applications existed for the same product.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.3>This question would be resolved by the debate in a rulemaking discussion.
GENERAL
GENERAL
<8: 1.2.4>
By all means the product in question should be correctly termed an abortifacient, since it can act to
prevent the implantation of a fertilized egg into the uterine wall, and the product labeling should contain
such information. This raises the question as to why it was approved in the first place since it is a lethal
drug.
COMMENT NUMBER - 2005N-0345-EC66
2005N-0345-EC66 - STRUCTURED DATA ELEMENTS
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 330 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 322
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Baird, Debora
2005N-0345-EC66 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
Yes
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.1>Yes
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>Yes
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1>Yes
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.4.1, 7.4.4, 7.4.6>Allow pharacists to card those purchasing the drugs and the purchaser must sign a
form stating "met age requirements". <6: 7.4.5>Recourse for illegal purchase can
be turned over to the local authorities for processecution.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
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<7: 8.2, 9.1.1>No, different strenghts of product, different and separate packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.1.1>None as long as "Plan B" Morning After pill is sold in a different strength and dosage, they are
not the same.
GENERAL
GENERAL
<9: 1.2.1>PLEASE ALLOW THE OVER THE COUNTER SALES OF PLAN B (MORNING AFTER
PILL). THIS WILL REDUCE THE NUMBER OF ABORTIONS AND GIVE WOMEN THE
FREEDOM OF CHOICE THEY SHOULD HAVE.
THANKS!
COMMENT NUMBER - 2005N-0345-EC668
2005N-0345-EC668 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Vrankar, Anna
2005N-0345-EC668 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.3.2>No, if an active ingredient needs the supervision of a physician because of potential side
effects, drug interactions, or because there might be physical conditions which would render taking such
an ingredient unsafe, it should remain "prescription only"
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No, see above
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B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>no
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.5>only if the rule made it clear that if a prescription is required, it is universally required.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2>NO!<5: 6.6.3, 7.5.3> Is the ban on tobacco sales to minors enforeceable? Absolutely
not.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.2>NO
GENERAL
GENERAL
<7: 1.2.3>Please protect our children's health! Keep these potentially dangerous prescription drugs
available by prescription only
COMMENT NUMBER - 2005N-0345-EC671
2005N-0345-EC671 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Friedl, Mary Frances
2005N-0345-EC671 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
no, the policy in effect now is adequate
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1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.2, 3.8.4>No, the policy in effect now is adequate. <2: 3.8.8>A change in this policy
could result in decreased safety for OTC drugs. It would shift policy definition from the scientific to the
political arena.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>no
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.2>no.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.2, 7.5.3>No, the population under limitation would simply approach the population not under
limitation in order to purchase the drug through a third party. The decision of whether or not to give the
drug to the subpopulation would be made, not by physicians, but by individual OTC purchasers.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 7.2>No.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.2>Under all purposes.
GENERAL
GENERAL
This is one can of worms that the FDA should not be opening. <8: 3.8.4, 3.8.8>Under the current
circumstances, some drugs are OTC and some are not because it is presumed that proper use of
prescription drugs requires specialized knowledge that is not available to the general public. Without this
knowledge, the public cannot truly give individual and personal consent to the possible consequences of
the use of the prescription drug. It these drugs are made OTC, the only source of information available to
consumers will be via inadequate package information or through the recommendation of the pharmacist.
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Any change in the current policy is going to negatively impact both the safety of the public and the role of
pharmacists.Patients will become mere consumers and pharmacists will become amateur physicians.
COMMENT NUMBER - 2005N-0345-EC677
2005N-0345-EC677 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Gordon, Jennifer
2005N-0345-EC677 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>If this means that it should change its rules to allow the simultaneous marketing of 'Plan B' as an
OTC and prescription drug, than no. See below.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Same as above. See below.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
See below.
C. If so, would a rulemaking on this issue help dispet that confusion?
See below.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.2>Without any real knowledge of law, I believe that a law must be reasonably enforceable to be real
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law. See below. <3: 6.5.3>Also, with respect to limiting OTC 'Plan B' to women over a certain
age, how does this stand legally with the resistance to parental notification laws for minors who wish to
obtain abortions? If, as many claim, it is illegal (violation of 'privacy') to require minors to notify parents
before obtaining an abortion, and since they don't need a prescription to undergo a major surgical
procedure, why should they not be allowed to decide on their own about taking 'emergency
contraception?' It seems very contradictory.
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.2>Absolutely not. <5: 6.6.3, 7.5.3>Just as minors easily purchase tobacco, alcohol and
other drugs, 'prescription-only' for under 16/17 year old women would be a joke. Not only could minor
women get friends and boyfriends to purchase this drug OTC, parents who wish to avoid the hassle and
expense of going to the doctor would also purchase the drug for their daughters. <6:
7.6>Moreover, what would prevent men who are already breaking the law by having relations with
minors from using this drug to cover up their crimes? This is already the problem with the striking down
of parental notification laws for minors procurring abortions. The men who responsible for these
pregnancies are able to pressure their victims into abortions without the parents ever knowing what is
happening. This drug would make that abomination even easier.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.2, 8.5.4, 8.9>This question is grammatically confusing. Does it mean that the prescription and the
OTC products will be sold together 'in the same package,' or that they will be sold separately in the same
packaging? Since the former doesn't make any sense, I assume it's the later, in which case, I think it
makes sense to sell them in different packages, so that there is some ability to distinguish between when
the drug was procurred as a prescription and when it was procurred OTC. Since it would be illegal for
minors to procure the OTC version of the drug, it seems important to be able to make this distinction.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
Again, this question indicates that the first interpretation of "in the same package" above was correct.
How is it possible to sell a prescription and a non-prescription in a single package?
GENERAL
GENERAL
Above, I answer the questions which have been posed by the FDA. <8: 1.2.4>What I have not stated so
far is my objection to selling "Plan B" at all. "Emergency contraception," like the Pill, employees an
abortifacient as its secondary effect. And as this "Plan B" is even stronger than the Pill, it would be
causing many more early-term abortions.
It seems a gross violation of the FDA's purpose to approve the sale of a drug that is not used to heal or
cure anything, but rather to take life. And as studies have already shown, the "Morning After Pill" has not
succeeded in reducing the number of unintended pregnancies or abortions. It also provides absolutely no
protection against STDs. It's another "safe-sex" fable that will lull even more young women (and men)
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into a dangerous mentality of sex without consequences. The FDA, by approving "Plan B" would be
exposing women to more risks of health and life, not improving health care for women. Not only would it
be immoral to approve the sale of this drug, it would also be pointless, as it has not been shown to have
any practical value in the reduction of "unwanted" pregnancies. If there are strong moral reasons NOT to
approve the drug and NO practical reasons to approve it, the FDA will be acting both immorally and
illogically if it approves the sale of "Plan B."
COMMENT NUMBER - 2005N-0345-EC678
2005N-0345-EC678 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Socha, Kathleen
2005N-0345-EC678 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
No. <1: 1.2.3>A drug so powerful that it can kill a person shouldn't be sold at all. But if you must, then by
prescription only for all ages.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes. <2: 3.9.1>I take a drug sold both ways. I buy by prescription because my insurance pays for it that
way.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>No. <4: 4.4.2>I think the problem lies in trying to limit the age to purchase the OTC
drug.
C. If so, would a rulemaking on this issue help dispet that confusion?
<5: 5.2>Only to you.
2
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A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<6: 6.2, 6.6.3>You can't even prevent kids from buying cigarettes or alcohol. What are you thinking?
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 7.2>Not possible.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 8.6.2>It would make it easier for the kids to get the right one.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<9: 9.1.1>When the product can kill a person. Adults die from this drug too.
COMMENT NUMBER - 2005N-0345-EC680
2005N-0345-EC680 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Schulz, Stan
2005N-0345-EC680 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No. <2: 3.8.8>This would open the floodgates for evermore trivial excuses to market
products which have been judged dangerous enough to require professional oversight -- through a
prescription.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
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when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No. This would open the floodgates for evermore trivial excuses to market products which have been
judged dangerous enough to require professional oversight -- through a prescription.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.5>No confusion regarding present practice; plenty of confusion over what may happen in the
future.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.2>No. <5: 5.4.2.2>It would only change a simple "esy/no" issue into a complex one
requiring measurements (of age, for instance) or status (married or not), and set the groundwork for
requiring additional bureaucratic action (for instance, requiring proof of age)and the possibility of
fiviolous lawsuits based on the decision of a drugstore clerk.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<6: 6.2, 6.5.4>Probably not. It would result in lawsuits challenging the right to restrict sales; challenging
the appropriateness of the cutoff age, alleging age discrimination.
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 7.2>No. <8: 7.5.3>As a practical matter, any young girl could find a friend over the age of
16 who could buy the drug and give it to the youngster. Also, any young MAN over the age of 16 would
gladly buy the drug for his underage lover.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<9: 8.1, 8.4.1>Sure. The packaging would make no difference --- it's the person making the purchase who
makes the difference.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<10: 8.9>There are not "two products". They would be the same with just different locations and sales
restrictions.
GENERAL
GENERAL
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<11: 3.3.2>Any product which has been judged sufficiently dangerous to warrant professional
supervision via prescription -- should not be presented to the public without such protection. <12: 7.5.3>It opens the product to many forms of abuse -- purchase of the product by one qualified
person for the use of another unqualified person; purchase of multiple packages of the product for over-
use "just in case"; purchase of the product with intent to resell it at a profit to an unqualified person, etc.
COMMENT NUMBER - 2005N-0345-EC691
2005N-0345-EC691 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Carter, Thomas
2005N-0345-EC691 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
I am not sure what the interpretation is. <1: 1.2.1, 1.2.2>I will say that I support OTC status. Short of that,
I support a dual OTC/prescription status.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
I am not sure what the difference between "act" and "action" is - may I suggest including some
background in "plain english" for those of us who are interested laymen, but not lawyers? Otherwise, see
my answer for the first question.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes - I am not even sure what it is!!
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>It would seem so, although I do not know what the ramifications of such a rulemaking would
be.
2
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A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1>Yes, I believe so.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.1, 7.4.3, 7.4.4>I assume the "subpopulation" would be legal minors, under the age of 16-18. The
limitation could be enforced by having undercover "minors" attempt to purchase the product OTC. Such
practices are engaged in voluntarily by some retailers, e.g. Wal Mart IDs purchases of spray paint and
alertness aids.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1>This question is a little beyond my knowledge, but on the face of it, I believe so.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.1>If it is determined that a special package, i.e. instructions designed to be easily understood and
targeted to minors, is needed for the prescription package.
GENERAL
GENERAL
<8: 1.2.1, 1.2.2>Once again, I believe that per the original recommedation, this drug should have been
given OTC status. Short of that, I would support a dual OTC/prescription status.
COMMENT NUMBER - 2005N-0345-EC7
2005N-0345-EC7 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dawson, Jennifer
2005N-0345-EC7 - TEXT
Issue Areas/Comments
2
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A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 6.1>Yes, the limitation would be easily enforceable. <2: 6.4.1, 6.6.3>Such limitations
already exist for medicines like nicotine-replacement therapy, as well as for other controlled substances
such as tobacco and alcohol.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.1, 7.4.1, 7.4.4>Pharmacists could be required to check IDs for customers. If pharmacists can be
trusted with dispensing addictive and potentially dangerous pharmaceuticals, clearly they can be trusted to
check to ensure customers are of legal age. <4: 6.6.3, 7.4.3, 7.4.5>If there was
concern that pharmacists were not carding customers, undercover operations could be used as they are
with tobacco and alcohol, and fines could be levied.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.1, 9.1.1>I see no problem with selling prescription and OTC medicines in the same package, so
long as their distribution is controlled.
GENERAL
GENERAL
<6: 1.2, 2.1>I hope that the FDA rules promptly on this issue. American women have been waiting too
long for emergency contraception, which is clearly safe and effective, to be on drugstore shelves.
COMMENT NUMBER - 2005N-0345-EC710
2005N-0345-EC710 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Devine, Naomi
2005N-0345-EC710 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
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drug product?
<1: 3.8.8>If the products are identical and for identical uses, all should be regulated.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1, 4.3.4>Yes, there is confusion. It is hard to understand why a drug should be prescription for some
and over the counter for others.
C. If so, would a rulemaking on this issue help dispet that confusion?
Perhaps.
2
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.2, 7.5.3>No. In practicality, this type of restiction would be nearly impossible to enforce.
GENERAL
GENERAL
<4: 1.2.3>All other forms of birth control pills are available only by prescription. Why would this one be
sold over the counter? It is dangerous and irresponsible of the FDA to allow a drug to be sold over the
counter when the Agency has determined that it is unsafe for a large sub-population. Especially in this
circumstance, where this sub-population would be highly interested in the drug. If this drug is unsafe for
those under 17 -- it should not be sold over the counter at all.
COMMENT NUMBER - 2005N-0345-EC716
2005N-0345-EC716 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hager, Joseph R
2005N-0345-EC716 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
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drug product?
<1: 3.2>NO! 1. <2: 8.5.4>There is no way to control the dispensing that "medicine" if packaged
the same. 2. <3: 1.2.3>As a parent, I object to a "birth control" drug being made available as
an over the counter drug for my daughter under the age of 18 because I am still responsible for her health
and safety, and her development, and a birth control drug available to her over the counter would usurp
my parental authority. 3. <4: 7.5.3>Allowing an active medicinal ingredient simultaneously
marketed in both a prescription drug and an OTC drug product would leave the use of the drug open to
misuse/abuse.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No! See above answer.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Not able to make a knowledgeable response.
C. If so, would a rulemaking on this issue help dispet that confusion?
Unknown.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.5.4>I say that the pharmicist/pharmacy/store is in danger of being prosecuted because they
unintentionally/inadvertantly sell an OTC drug to some one who was authorized the drug only by
prescription.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.2>No!
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.9>Are you asking a legal question of non-legally trained people?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 8.9>Without a parent's approval.
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COMMENT NUMBER - 2005N-0345-EC717
2005N-0345-EC717 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Gorini, Joseph
2005N-0345-EC717 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2>First, please consider whether or not the FDA should be answering this question with regard to
Plan B. Plan B should not be considered to fall under the FDA's concern for 'health and safety.' See
General Comment.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
First, please consider whether or not the FDA should be answering this question with regard to Plan B.
Plan B should not be considered to fall under the FDA's concern for 'health and safety.' See General
Comment.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>If the FDA applies section 503(b) it would ceate confusion by seeming to accept Plan B as falling
under FDA's concern for 'health and safety.' See General Comment.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>Rule making on this issue with regard to Plan B would confuse the proper understanding of
'health and safety.' Plan B should not be considered to fall under the FDA's concern for 'health and safety.'
See General Comment.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
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matter of law?
What is the FDA's experience with other abortifacients?
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.2>No!
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
I would hope not!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<5: 9.1.2>Always.
GENERAL
GENERAL
<6: 1.2>In and unusual exchange this week in the US Congress, among the highest ranking UN officials
admitted that the term "reproductive health" does not include abortion, at least in the context of the
recently decided Millennium Summit Declaration. The exchange came during a hearing of the US House
Committee on International Relations when Congressman Chris Smith questioned Mark Malloch Brown,
senior adviser to UN Secretary General Kofi Annan. Smith asked Brown three times if "reproductive
health" included access to abortion. Brown finally admitted that it did not.
COMMENT NUMBER - 2005N-0345-EC73
2005N-0345-EC73 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Ricci, Stephen
2005N-0345-EC73 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
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<1: 3.1>Yes
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>It is more likely
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.7>Not without a means to verify the end-user of the product, as is with a valid RX signed by a
licensed practioner for a single patient
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2>I do not believe it is likely even as a practical matter.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2, 8.8>This is the case with one particular ingredient: Meclizine 25mg tablets are currently either
labeled for RX or OTC distribution. The package must be labeled accordingly, as so it cannot be
produced by a manufacturer in 'the same package' unless it is one labeled for OTC
GENERAL
GENERAL
<7: 1.2.3>I as a licesnsed healthcare practioner do not approve of the sale of Plan B as an OTC entity.
COMMENT NUMBER - 2005N-0345-EC76
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 347 of 415
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2005N-0345-EC76 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Rosati, Lucia
2005N-0345-EC76 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.5>I believe it is acceptable to consider drugs on a case-by-case basis. <2: 1.2>In the
case of Emergency Contraception/Plan B, I can appreciate the concerns about selling to minors.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
I believe that if a drug is considered safe when used approriately, it should be sold as over-the-counter --
period. <3: 7.4.4>If there are concerns regarding the age of purchasers/users, leave it up to the individual
retailer to "proof" the person if they so wish. <4: 1.2.1>I don't see any disadvantage, however,
to an individual using Plan B even if they're 15 years old. At least, a pregnancy will not result, which is
much worse.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<5: 4.1>Yes. <6: 1.2.1, 2.1>The drug should have been allowed based on it's safety -- nothing
else. You don't see cigarettes being sold prescription to minors, but over- the-counter to adults. And
cigarettes are much worse. The only reason you are hesitating to rule on this drug is because of the
religious concerns of certain segments of the population. I believe that that violates the rights of American
women who would benefit from its availability.
C. If so, would a rulemaking on this issue help dispet that confusion?
<7: 3.8.5>Maybe so; but again, I think each drug should be considered on a case-by-case basis. In most
cases, I don't see why a drug would be safe only for certain people. Either it's safe or it isn't.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
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<8: 6.1>The FDA through the pharmacy chains would be able to enforce it just as they enforce any other
prescription medication.
B. If it could, would it be able to do so as practical matter and, if so, how?
<9: 7.1>How does it normally enforce the sale of prescription drugs? However, the drug would have to
merit regulation. <10: 1.2.1>In the case of Plan B, there's no reason why it cannot be available
over-the-counter to any woman seeking it, no matter the age.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<11: 8.1, 8.4.1>Certainly. I don't see why packaging would have to change. Only the manner in which it
is sold would have to change.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<12: 9.2.2>I cannot think of any.
GENERAL
GENERAL
<13: 1.2.1>I think the time has come to make Plan B contraception available to women over-the-counter.
This is a safe drug and would reduce the number of unwanted pregnancies, and therefore, the number of
abortions. I urge you to act quickly on this. It has taken long enough and has been found to be safe.
COMMENT NUMBER - 2005N-0345-EC762
2005N-0345-EC762 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Long, Laura Jean
2005N-0345-EC762 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
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drug product?
<1: 3.2, 3.9.1>The FDA has already approved the use of drugs in both simultaneous prescription form
and over the counter form, ie. Claritin. I argue that such allergy drugs are still only used by allergy
sufferers, not the entire population, and yet they are available for use by all. <2: 2.1,
3.2>Denying the approval of Plan B as an over the counter drug, especially after being so overwhelming
approved for such use in clinical recommendations, appears to be a direct (embarrassing) cow-tow to a
particularly vocal political minority. No ruling is necessary if the panel on the FDA would take
responsibility for their positions as scientists and attempt (and act) as objective voices for the health of the
public (rather than the interests of lobbying groups, be they political or pharmaceutical).
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
This question is the same as the previous question with minor change (act - action, marketed - market).
My answer still stands.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>No, there is not significant confusion. <4: 1.3, 2.1>Your interpretation of the 503(b) text
is just an excuse to delay the approval of a safe drug for the OTC market (where was the need for clarity
on 503(b) when truly dangerous drugs like Vioxx and Celebrex were so hastily approved?). In failing to
rule objectively you disappoint your public and endanger their health.
C. If so, would a rulemaking on this issue help dispet that confusion?
<5: 5.2, 5.4.2.2>I fear that rulemaking on this issue would only further codify the opinion driven barriers
which prevent scientific recommendation from being heeded.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<6: 6.2>No. <7: 6.5.4>Limiting the sale of an OTC product to a particular subpopulation (in this
case, the "subpopulation" being HALF the population, ie. women) by making it prescription only is
tantamount to discrimination.
B. If it could, would it be able to do so as practical matter and, if so, how?
<8: 7.2>It would not be able to do so as a practical matter. This question presupposes making an
OTC drug prescription only is "a practical matter" when the drug is only used by a segment of the
population. It may be argued that all drugs are only used by a segment of the population, when they so
need them. This question also presupposes that the FDA's job is to regulate drugs for "practical matters". I
find this presupposition appalling. <9: 1.2.1>I am challenged as to whether I should lose my faith in the
FDA as an objective, regulatory commission with the best interests of the American public at heart. It is
impractical to continue to keep a safe drug prescription only, especially when its effectiveness is so
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dependent upon a crucial time- window - 72 hours, but the sooner, the better. By continuing to keep Plan
B as prescription only, you are patently interfering with the effectiveness of this drug, by making it
difficult and time-consuming for the drug to be obtained by those who need it.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<10: 8.1>Yes they may legally sold in the same package. <11: 8.9>In fact, a more useful law
would be one preventing pharmaceutical companies from artificially inflating the price of either the OTC
or prescription version.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<12: 9.2.2>I find no circumstances in which it would be inappropriate to do so.
GENERAL
GENERAL
<13: 1.2.1, 2.1>It is reprehensible that the FDA has delayed the approval of a drug (Plan B) that has been
proven safe and highly recommended by clinicians for use over the counter. I dare to hope that the panel
will grow a spine and rule on this and all other future drug recommendations from an objective
motivation, untainted by politics or profit. In continuing to deny safe drugs, such as Plan B, on the market
to those who need them, you are effectively endangering the health of the public.
COMMENT NUMBER - 2005N-0345-EC77
2005N-0345-EC77 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Carlson, Brent
2005N-0345-EC77 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes. <2: 1.2.2>Access without a prescription in the 17 year old and above is reasonable
and will help prevent unwanted pregnancies.
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1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.2>No.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1>Yes. <5: 7.1, 7.4.1, 7.4.4>You could either require identification at the point-of-sale or
require dispensing by a pharmacist (with ID).
B. If it could, would it be able to do so as practical matter and, if so, how?
See "A".
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2, 8.3.1>The "legend" would have to be modified to read "for patients under 17 years of age".
GENERAL
GENERAL
<7: 1.2.2>This appears to be a compromise that will at least provide easy access to prevention of
unwanted pregnancies for women 17 or older until a more effective "treatment" is approved.
COMMENT NUMBER - 2005N-0345-EC779
2005N-0345-EC779 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Macdonell, Megan
2005N-0345-EC779 - TEXT
Issue Areas/Comments
1
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A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.9.1>There are many medications that have the same active ingredient available in both a
generic/OTC method as well as through prescription. With that said I am also unaware of the guidelines
by which these decisions are made, however I do not personally see it as a problem. I believe that there
should be a "re-wording" of section 503(b).
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.6.3, 7.4.1, 7.4.4>I believe that a controversial product like Planned B should be placed behind the
counter (at the register) to control the buyers age of this product. I am from Oregon, and here our legal
age to buy cigarettes is 16 years of age. I believe that if this product was kept behind the counters
(literally) that this will prevent theft and the ID's of the buyer can be checked before the product can be
purchased. If the consumer does not have a Drivers License or and ID with their birthdate on it, then I
believe they should need a form of proper identification that includes their date of birth.
B. If it could, would it be able to do so as practical matter and, if so, how?
<3: 7.1, 7.3.1.2, 7.4.4>I do not believe that the process I described above is unpractical or difficult to
accomplish. I believe that cashiers just need to be trained at looking for proper ID's (which generally they
are) as well as the use of discretion while serving these consumers.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.1>I believe that they should be allowed to be sold in the same package. <5: 8.3.4>I also
believe that perhaps the packages that are sold in stores should have information about the risks of this
medication and facts about why this is called emergency contraception, and that it in no circumstance
should replace normal contraceptive measures. The subpopulation under 16 who would get it through
prescription will have their doctors explain these facts. So I do not believe that it would hurt to have an
extra procautionary measure included in the OTC meds.
GENERAL
GENERAL
<6: 1.2.2>I believe that making the Planned B birth control available without a prescription to women age
16 and older is a progressive measure. I believe that the girls under 16 should seek a health practitioner
for this medication so that they can be properly notified about the risks that are involved as well as the
term "emergency". I believe this way, perhaps they can get the help they need, while also getting
information about how to help their bodies and perhaps recieving another form of protection for the
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future. I also believe that perhaps the packages that are sold in stores should have information
about the risks of this medication and facts about why this is called emergency contraception, and that it
in no circumstance should replace normal contraceptive measures. The subpopulation under 16 who
would get it through prescription will have their doctors explain these facts. So I do not believe that it
would hurt to have an extra procautionary measure included in the OTC meds.
COMMENT NUMBER - 2005N-0345-EC788
2005N-0345-EC788 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Phlips, Thomas
2005N-0345-EC788 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
Not in the case of Plan B.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.2>No.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>No.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
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<4: 6.1>Probably.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.5.3>Very difficultly.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.4.1>This is an absurd question: after some time people will know the way (ex. a friend or relative
with the required age of 17 years) how they can buy it OTC and the different package for prescription will
be of no use.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.2>Any.
GENERAL
GENERAL
<8: 1.2>One of the main arguments for providing an OTC version of Plan B and similar products is a
presumed reduction in the number of needed pregnancy terminations of unwanted pregnancies. Similar
products have been approved for OTC use in several countries in Europe (Great Britain, Belgium,
France,...), many times with this same argument of reducing the absolute number of pregnancy
terminations. In september 2000 Norlevo was introduced as an OTC product on the Belgian market. Now
on a total population of 10 million persons more than 1OO.OOO units are used each year. The number of
pregnancy terminations has increased significantly since then: 14923 in 2000, 16707 in 2003 (an increase
of 21%). The number of OAC remained stable in that period and there was a major increase in pregnancy
terminations in the 12-20year age group. Recent (unpublished, 2004-2005) numbers indicate an even
higher increase. The same trend has been seen in Great Britain.
<9: 1.2>Is it possible to publish (or email) the review of scientific studies on wich the Center for Drug
Evaluation and Research or CDER, has based its conclusion that the available scientific data are sufficient
to support the safe use of Plan B as an over the counter product?
And what fysiologic argument is given to withhold it to women 16 years old and not to women who are
17 years and older?
Are there any large scale studies on the metabolic and cancerogenic long-term efects of these products
included in this review?
In recent years there has been seen an increase in early (30-40years age group) and often very aggressive
forms of breast cancer: have there been any studies undertaken to link the use of morning-after pills as
one of the possible causes?
Thanks,
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 355 of 415
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Thomas Phlips, MD
COMMENT NUMBER - 2005N-0345-EC793
2005N-0345-EC793 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kuskey, Garvan
2005N-0345-EC793 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
(See statement below in the comments section
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<1: 4.1>yes
2
B. If it could, would it be able to do so as practical matter and, if so, how?
GENERAL
GENERAL
<2: 3.1, 3.10>If 5% testosterone -- a completely benign substance -- must be written on a triplicate
prescription, then why not this more dangerous preparation?Or the reverse: if this drug can be marketed
without a prescription to those over sixteen years of age, then why can't 5% testosterone be marketed to
elderly men who need HRT? The FDA designated low-dose testosterone a dangerous drug specifically
because of its abuse by body builders. And yet, body builders don't use 5% preparations. In fact, they can
and do easily buy much more concentrated products in Mexico. <3: 1.3>Because you have
listed low-dose testosterone as a controlled substance, this relatively cheap substance is now priced
beyond the reach of many senior men: up to $250 for a one month's supply. I recommend that you
promptly de-list it so that those needing this soy-based bioidentical hormone can purchase it over the
counter for closer to $25 for a one month supply. Or does that make too much sense?
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COMMENT NUMBER - 2005N-0345-EC80
2005N-0345-EC80 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Cahoon, Clifton
2005N-0345-EC80 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>no
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
no
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.3.4>That is hard to justify or explain. It is my opinion that medications which are prescription
should not therefore have a simultaneous non- prescription status.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.4.2.2>I think it should continue to stay legend vs non-legend and not allow a ruling which would
not only put the particular drug at hand to be confusing but there would be too much leeway to allow
multiple drugs be given OTC status.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 3.8.7, 6.5.4>This is making it too confusing. I think they should not allow this subpopulation
seperation legal. It presents too many future regulations, regulatory parties, audits, etc. Yes a drug may
make OTC status but the monetary and regulatory burden placed therefore on the public would be
enormous. The drug would in essence be able to be free of that burden while then the burden rests on
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taxpayers and retail workers to pay for this drugs audits and regulations. Very unwise when the drug is for
such a limited population that the burden is then placed on the general public. Let the population for
whom the product is designed for seek to carry the burden by seeking a physician visit and prescription
given. This is a ridiculous request by a drug maker, it is obvious they will make the money, market the
product and then pass the burden of regulation and audit to the taxpayer. Abuse.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.2, 7.5.2>No, no, no. I have explained my rationale above. They would place the burden on society
as a whole for such a small population for whom it serves. It is not practical no matter how much the drug
company said they would monitor it, in the end we would end up paying for it as taxpayers. Very
inappropriate shuffle of burden.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2, 9.2.2>Not at all.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
see above
GENERAL
GENERAL
<7: 2.1, 3.8.8>This is a matter that the FDA must continue to monitor and not make a drug manufacturer
the controlling party. Do not allow drugs with such specificity as being subpopulation separated to
become the burden of all public buyers. The people who seek such specific medications must continue to
seek to establish a physician/patient relationship or pharmacist/patient relationship where legal to do so in
order to meet criteria. Let only those trained in health care specific to the disease decide the
appropriateness of therapy, not allow the general public to make that determination. It is a shift of burden
that must be kept with the FDA and regulated by legend drug rules, and not allowed to be made a public
responsibility to determine appropriateness of therapy. It only opens a large decentralization of
appropriateness of regulation, appropriateness, and cost.
COMMENT NUMBER - 2005N-0345-EC81
2005N-0345-EC81 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Schmierer, Ann
2005N-0345-EC81 - TEXT
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Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.8.4, 3.9.1>I think there are a number of drugs available OTC that are similar and used for
exactly the same indications as prescription drugs (i.e. Claritin OTC, Prevacid OTC), and there should be
no distinction made between the interpretation for these drugs, so why the confusion on Plan B? I believe
there is a very distinct political motivation behind this issue being raised. If the product is proven safe and
effective by the FDA for OTC, it should be made available to consumers that want it.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No. See above comments. FDA has made their recommendation, so follow it.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.4.2>I think it may be inappropriate for the public to make comments on "FDA's confusion" on the
interpretation. I believe there are adequate historical cases and presidence for a number of OTC
formulations and similar drugs only availble via prescription, all proven safe and effective by the FDA for
dispensing to patients and consumers. This is a political position taken by the Commissioner and the
office of HHS, and I believe he and the office should stand down and let the FDA do their job.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.4.3>I am unaware of the definition for the word "dispet" in the English language that is worded in
the question, and may be used intentionally to really incite "confusion". If the appropriate word was
intended to be "dispel", I believe there are adequate rules within the Federal Register for the FDA to do
it's job, and do not have a problem with their interpretation of what has been entered into the code of law
governing FDA.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 1.2.1, 6.5.4>If the FDA has ruled that this product is safe and effective for OTC designation, they
should make the product available to customers. Do pharmacies (or the FDA) restrict the sale of condoms
or contraceptive jelly to a 5 year old? Should pharmacies (or the FDA) restrict the sale of condoms or
other contraceptive items to a 10 year old? At what age is it appropriate to sell OTC contraceptive
items...who cares. If they are needed by a specific consumer, they have OTC designation, why should
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there be a gender bias against females that want this product? What about girls that are raped by a
stranger, their brother, cousins or fathers that would like to have some control over their reproductive
system? Give females the control their own decisions on this matter, especially when there is an FDA
sancioned product available that is deamed safe and effective for OTC use.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.4.1, 7.4.4, 7.5.4>If the FDA Commissioner, Secretary of HHS, and the President would like to
interfere in this FDA issue, and as a result there are restrictions placed on this product, I think the recent
ruling on pseudoephidrine-containing pills being available as OTC, but in limited quantity and behind the
counter at a pharmacy can make an example of how to deal with this situation. Make it available in a set
limited quantity that can be obtained from a pharmacist by asking at the counter. If there is some age
restriction imposed, then have the person produce proof of age, such as an ID card or driver's license to
provide that information. I feel that by producing such information is an invasion of privacy as the
pharmacist would know the identity and could possibly interfere with a personal matter by obtaining such
information for an OTC product. Are there HIPPA restrictions on phamacy personnel having access to
patient information (and interference with a request for an OTC drug) that can guide this train of
thought?
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.3.1>Typically, OTC and prescription formulations have different packaging, and I believe it is
appropriate to do so if it is deamed necessary to have pertinent health and usage information clearly
displayed on the packaging. Typically, presription packages do not come with detailed use information,
e.g. a pill bottle filled at a pharmacy, but pharmacies may provide additional information about the drug
by including a drug package insert or sheet. In this particular case you may want to have clearly displayed
information ON THE OUTSIDE OF THE PACKAGE on how to use the product (i.e. route of
administration, etc.) so there is no confusion for someone that is considering the purchase of the OTC
product and whether it is appropriate for them. There should be adequate information available, as for
cold remedies, for people on certain medications or or have certain health conditions that it is not
recommended for use.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.1>See above comments concerning existing health conditions or medication that the person is
taking that could jeopardize their health, or interfere with know medications (if that information is know
at this time). Examples of an OTC product that have warnings are numerous, such as aspirin not
recommended for those with a history of intestinal bleeding or clotting disorders, or cold remedies that
can adversely affect asthma sufferers.
GENERAL
GENERAL
<8: 1.1>I consider the delay in the availability a blatant display of political interference by the FDA
commissioner, the commissioner's office, the Secretary of HHS, and the president of the United States. I
and many within the US public, believe the integrity of Secretary Leavitt, Commissioner Crawford, and
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the organizations they 'lead' are irreparably damaged by caving in to political pressure and presidential
mandates. If people do not want to use this product for political or religious reasons, individual women
have the right to make that choice. Many states have spoken on the issue and have drafted bills within
their legislative bodies to make Plan B available to the consumers in their states. Large bodies of people
have spoken through these state legislative actions, and their opinion on the availabilty of this product
quite obvious.
I think it is time for Secretary Leavitt and Commissioner Crawford to stand up and support the scientific
evidence provided and reviewed extensively by the FDA, support the lawful process outlined in the
Federal Registry that guides FDA, stop interfering with a company's product for political reasons, and
make this product available. The longer this drags on and the more delays imposed by the Secretary,
Commissioner and President, the more damage you do to instituting a SCIENTIFICALLY-BASED FDA
process, damage to commerce by interfering for political gain, discrimination against poor women by
denying access to Plan B OTC, discriminate against women that do not have access to adequate
healthcare (a doctor's needed prescription and payment of drugs) due to the lack of insurance, and risk the
alienation of women of the United States. These delays and obstructions will only damage the reputation
of the stated government individuals, and the organizations they are representing.
<9: 1.2.1>The law is clearly stated, the FDA has thoroughly reviewed the product's safety and efficacy, so
stand down and let this product proceed to comsumers that choose to use it. Do not make this an issue of
women wealthy enough to travel to states or countries where this product may be freely available in the
future, or only those with medical insurance coverage. I believe this is a blatant discriminating act
towards poor and uninsured women of the United States. Give these women OTC options that do not
require a prescription that they do not have access to or the means to pay for as long as the product is safe
and effective. Condoms and contraceptive jellies are not enough--bring this option to the the consumer,
and let THEM make the choice. No one would be forcing anyone to use this product, but it should be
made available to women that feel this treatment is appropriate and compatible with their health care.
COMMENT NUMBER - 2005N-0345-EC811
2005N-0345-EC811 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Camron, Kiera
2005N-0345-EC811 - TEXT
GENERAL
The comments below were published in the "Tallahassee Democrat" on September 9, 2005. The author is
Kiera Camron, responding to an editorial by Mary Ann Lindley.
<1: 1.2.3>Mary Ann Lindley calls the morning-after pill, or ?emergency contraception? (EC), a
?blessing.? Apparently, her definition of ?blessing? and mine are opposites.
Many descriptions of the various methods of EC call these regimens ?mega-doses? of the chemicals
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found in daily birth control pills. (For example, the ?Plan B?EC kit?s two pills, to be taken 12 hours apart,
contain the same amount of levonorgestrel that a birth control pill user would ingest in about 20 days.) It
follows, then, that EC users could experience many of the same serious side-effects that birth control pill
users can experience (blood clots, strokes, heart attack, tumors, even an increased incidence of sexually
transmitted disease) and then some: add inconvenient nausea and vomiting and even the potentially fatal
ectopic pregnancy. Women who have historically suffered from a variety of health issues or who smoke
are more vulnerable to the dangerous side-effects of EC.
EC is also contraindicated for routine contraceptive use, so it?s not safe to use over and over again in the
place of other contraceptives. But women?s lifestyle choices could be significantly altered if they have
some sense of ?safety? because they perceive EC to be a ?back up.? Poor choices and risky behaviors are
associated with sexually transmitted disease infection, including HIV, and particularly among people
under age 25, where two-thirds of STD infection occurs. Some sexually transmitted diseases are viruses
that a woman will carry with her for the rest of her life; some cause dramatic damage to women, including
sterility and cervical cancer. EC provides no protection whatsoever against these sexually transmitted
diseases.
EC doesn?t stop at harming women; it harms the most defenseless among us, newly conceived boys and
girls. Although Ms. Lindley claims that EC does not cause very early abortions, the FDA and the Alan
Guttmacher Institute say that it can interfere with the implantation of early embryos. Both concur that,
among several mechanisms, EC may work by either interfering with an embryo?s movement through the
fallopian tube toward implantation in the uterus or by changing the lining of the uterus, making it
inhospitable to the embryo. That new life is lost to his or her parents, and to the world. What is worse, he
or she is lost without anyone?s knowledge because EC proponents obscure the truth about this mechanism
of the drug.
<2: 3.1, 3.8.3>Despite all of these risks, proponents are agitating (loudly) for these drugs to be made
available over the counter, available without the advice of a medical professional who would provide vital
education and assessment of a woman?s risk. The well-being of Americans is at stake; it is the FDA?s
responsibility to ensure the involvement of medical professionals and prevent the over the counter sale of
EC.
Planned Parenthood claims that EC will prevent 1.7 million unintended pregnancies and prevent 800,000
abortions each year in the United States, yet studies in the prominent medical journal The Journal of the
American Medical Association and others in countries where EC has routinely been used for years show
no change in pregnancy rates with over the counter availability of EC. So why the stubborn promotion of
EC? What agenda could possibly justify the exploitation of American women?
I, for one, am thankful for the FDA taking the time to look more carefully at this dangerous drug. With
any luck, they will conclude that over the counter EC is one ?blessing? America can do without.
COMMENT NUMBER - 2005N-0345-EC813
2005N-0345-EC813 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Wagner, Patricia
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2005N-0345-EC813 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 8.6.2>If an active ingredient is marketed in both prescription and OTC forms the packaging and
advertising should be clearly different. Assuming that people with no medical training can differentiate
carefully nuanced differences invites an increase in drug induced adverse effects that will eventually lead
to a distrust in the pharmaceutical industry by the general population.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.1, 8.6.2>The FDA should issue an interpretation of section 503(b) that requires that when drugs are
simultaneously marketed as both prescription and OTC their packaging and advertising must be so
dissimular that the ordinary customer will identify them as two different products.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.6.3, 7.5.3>Over the last several decades we have had laws forbidding the purchase of tobacco and
alcohol by those under age. It has been very difficult to enforce and is frequently circumvented by simply
having an older friend or acquaintance make the purchase. As it has become increasingly common for
adult men to seek out minor females as sex partners, how will they be prevented from purchasing OTCs
and using coercion to convince their "girlfriends" to use them or even slipping them into their food or
drink without their knowledge?
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.5>It would seem to be an invitation for lawsuits against pharmaceutical manufacturers.
COMMENT NUMBER - 2005N-0345-EC82
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2005N-0345-EC82 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Fogelgren, Katharine
2005N-0345-EC82 - TEXT
Issue Areas/Comments
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 1.2.1, 6.5.4>I am really struggling with your stance on this issue. Why was age 16 years first chosen
(by the manufacturer), and then increased by FDA to age 17 years? Upon what cognitive/decision-making
abilities (or other) human FEMALE developmental empirical evidence were either age chosen based? In
case you folks didn't know, the average age of menarche in the US human female is far, far below age 16
or 17. There are thousands (probably many more) unintended pregnancies annually in US young women
aged below 17 years. What about their rights to obtain such an important, life-altering medication? In
many states, they have long ago been granted medical decision-making rights to seek reproductive
healthcare without parental/guardian consent; apparently there is sufficiant evidence to support that even
a 12 year old female has the cognitive skills to avail herself of this type of service. Granted, in most
clinics there is healthcare provider oversight of the learning process... I am concerned that a large (and
very vulnerable) subpopulation who perhaps really is able to comprehend the risks/benefits of such a
critically important treatment option is being summarily denied the opportunity to do so with the FDA's
age qualification of 17 years. Then again, I can certainly foresee all the products liability, med-mal &
various other varieties of attorneys just biding their time to file suit with the first "bad" outcome... No
easy answers to this one, I know.
COMMENT NUMBER - 2005N-0345-EC827
2005N-0345-EC827 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: O'Hagan, James
2005N-0345-EC827 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
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when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
Yes it should. FDA rules are much more readily available as meaningful information to typical
consumers.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.1>Yes it should. <2: 3.8.3>FDA rules are much more readily available as meaningful
information to typical consumers.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1>Information regarding this interpretation is not well understood by the general public today.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.1, 5.3.1>A rule making on thi sissue helps significantly because of the clear, concise language
which typically accomponies such rulemaking on the FDA site. While other information is also available
on the site, a rulemaking is a more formal, dated document which is often used as a starting point by other
stakeholders in creating their own communications.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 1.2.3, 7.5.3>I am not qualified to answer that question, but I do know, firsthand, that there is already
active lawbreaking and misrepresentation going on in society with respect to this medicine and that
removing it from prescription for even a small subset of the population will have the practical impact of
removing it from prescription for everyone.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.2>Clearly not. <7: 7.5.3>Look at methamphetamines and alcohol as examples!
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 7.4.3, 8.5.3>It would be far preferable to have different National drug codes: then pharmacies could
program POS systems and pharmacy automation systems to help police the use.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
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inappropriate to do so?
<9: 8.6, 8.6.3, 8.6.4>Why do you want to encourage someone with a prescription, likely subsidized by an
insurance plan, to begin sharing their medicine with someone else? If it is legal for this drug, how will
you communicate that it is illegal for other drugs?
COMMENT NUMBER - 2005N-0345-EC83
2005N-0345-EC83 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Smith, Rodney
2005N-0345-EC83 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.3.2>No. How can a drug be both, especially when the Rx form is of a HIGHER
concentration?
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.1>Yes.
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.2>No.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
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the different products be legally sold in the same package?
<5: 8.2>No.
GENERAL
GENERAL
<6: 1.2.3>How can a drug be both OTC and Rx, especially when the proposed OTC dosage is higher than
the Rx dosage?
This drug should not be available to minors. That is reason enough to keep it as an Rx.
What about the pharmacists who might refuse to dispense it?
COMMENT NUMBER - 2005N-0345-EC839
2005N-0345-EC839 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Jago, Laura
2005N-0345-EC839 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.8.4>As been the process for a long time, the FDA has a statute that an active ingredient may not
be simultaneously marketed in both prescription and OTC drug product. This should stand as is, and not
be modified just for this one product. FDA makes these regulations for sound reason and should not be
overturned just because a case arises with political interests. I am a pharmacist and what I do is guided by,
and I rely on, these statutes. The FDS should stick by its regulations, which have worked so well over
time.<2: 3.8.8> It would be confusing to have a drug both marketed as prescriptions only
and over the counter, especially when there is no difference in the drug or packaging.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<3: 3.2, 3.8.4>Again, a single active ingredient should not be marketed both as prescription only and over
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the counter. FDA should stick by their policy which has been in place for many years, without prior
incident. They should not make an exception or worse, initiate rulemaking to change this.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2>No.<5: 7.5.2> there would have to be extensive regulations as to its access. many
pharmacists are crunched for time as is. see below.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.5.3>It might prove difficult to determine who is eligible to receive the OTC item versus the Rx
item-ie, how can we be sure that the person intending consumption falls over the age of 16 or 17? <7: 7.4.1>In this case, pharmacists would have to control the sale, maybe including the OTC
product behing the counter although still OTC. <8: 7.4.4, 7.5.3>We would have to ask for
identification, which may prove difficult if the person does not have a drivers license yet (age 16 or 17
may not have one yet). <9: 1.2.3, 6.5.3, 7.6>Another issue is that many pharmacist
currently have the option NOT to dispense emergency contraception (the case in Maryland),due to
relgious beliefs. These pharmacist would also carry this into the process of selling the item OTC.
Pharmacists who currently object to dispensing the prescription Plan B would also object to dispensing
this item OTC. Taking away that right to object by allowing OTC sale would forfeit the current right to
object which has been ruled on, and allowed as long as the Rph refers the patient to another pharmacy
who is willing to fill the prescription. Personally, as an Rph with CVS practicing in MD, I was given the
opportunity to object to dispensing/filling prescription Plan B, which I enthusiastically took. Allowing
this product to go OTC would obliverate this right of mine to refuse to dispense, since I object to its use
in those over the age of 17 as well.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<10: 8.2>no.
GENERAL
GENERAL
<11: 1.2.3>Allowing this product to be available OTC, even to a limited population (ie, those over age
17) would be horrific. Having this product OTC would promote unsafe sexual activity overall, increasing
the cases of sexually transmitted diseases. When a child/adolescent knows that there is a quick, easy and
widely available way to "repair" their situation, they will not take the precautions that they will wihtout
this method being so widely available. There is already significant morbidity and mortality associated
with STDs. We as a nation are fighting hard and spending billions of dollars on a cure for AIDS, and this
move from Rx to OTC will only make the AIDS epidemic worse. When there are no reprocusions for
actions, they will engage in these actions-when a patient knows there is a product over the counter to
prevent pregnancy right after she engages in unprotected sex, she will. Having this product avaialble OTC
will only increase unsafe behavior, and decrease personal responsibility for ones actions (unsafe sex).
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Yes, studies that have shown evidence to the contrary, but they have been short term in nature, with only
a few months to a year in follow up and not powered sufficently. People will see they do not have to take
the full responsibility for their actions, and will be less careful with sex knowing there is a security
blanket. This means those who use the product will use it repeatedly, which is not its inteded use. Over
time having this product available OTC will inevitably lead to increased (unlabeled) use, misconduct and
unsafe sexual practices increasing sexually transmitted disease and morbity and mortality.
COMMENT NUMBER - 2005N-0345-EC85
2005N-0345-EC85 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Oyola, Sandra
2005N-0345-EC85 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.1>Yes. This would clarify the regulations for any future products that may be sold either as
prescription or OTC.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes, same comment as above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>I do not feel there is.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.3.2>Yes, because consumers and manufacturers will have a better understanding of the
regulations.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
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available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2>I do not believe so. I do not agree with limiting sales to a subpopulation.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.6, 8.7>This could be very confusing to consumers and even health professionals. For example,
Zantac OTC is clearly marked as being OTC, yet it has the same ingredient as the presciption product.
This information is included on the packaging. It could also affect insurance coverage/reimbursement.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 8.9>Persons of other countries who buy the product here in the U.S. It may be illegal in their country
to obtain the medication without a prescription, or, the regulations of their country may require separate
and distinct packaging.
GENERAL
GENERAL
<7: 1.2.2>I certainly hope the FDA does not succumb to the will of the religious right in this country. If a
product is deemed safe, and can help people, it should be allowed to be sold to a consumer. Moral beliefs
should not be the deciding factor whether or not medications can be sold over the counter. Perhaps in the
near future, pharmacists can privately counsel patients on the proper use of Plan B when a purchase is
made. Although Plan B is not a substitute for birth control, it can help reduce the number of unwanted
pregnancies in this country, and help women retain their reproductive rights.
COMMENT NUMBER - 2005N-0345-EC860
2005N-0345-EC860 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Oberst, Sara
2005N-0345-EC860 - TEXT
Issue Areas/Comments
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
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available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 6.1>Yes, the FDA should be able to sanction pharmacists or pharmacies that are not in
compliance.
B. If it could, would it be able to do so as practical matter and, if so, how?
<2: 7.1, 7.4.3, 7.4.5>It should be able to take complaints and/or perform random visits to pharmacies.
Any found to be acting illegally should be warned with an ultimate penalty of a fine and/or suspension of
license.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<3: 8.1, 8.3.1, 8.3.4>Yes, as long as the appropriate warning is on the outside of the package.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<4: 9.1.1>If the drug caused a severe reaction in one subgroup of the population. By severe I mean death
or permanent damage to one's health.
GENERAL
GENERAL
<5: 1.2.1>Everyone agrees that unplanned pregnancy is a problem in this country. This includes teens,
women who've been raped and those whose contraceptive methods fail. As a matter of public health, it is
imperative that women have the ability to easily access emergency contraception. By providing this
option the number of abortions performed in the US, which has remained steady at about 1.5 million for
15+ years, would decrease; there would be less women and children living in poverty; and rape victims
would more easily recover from their assaults. In the case of EC the FDA MUST listen to the scientific
evidence. Any other decision would greatly diminish the integrity of the association.
<6: 1.2.1, 6.6.3>Although I believe that all subgroups should have access to OTC EC, any improvement
over the status quo would be welcomed. Perhaps few prescription drugs are treated in this manner, but
there are many other examples of assigning age restrictions on substances. Of course with tobacco, for
instance, some adolescents under the age of 18 will end up purchasing a pack of cigarettes, but this is a
small minority. And because no woman truly wants to use EC it is unlikely that any age restrictions
would be broken.
COMMENT NUMBER - 2005N-0345-EC870
2005N-0345-EC870 - STRUCTURED DATA ELEMENTS
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 371 of 415
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Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Vander Bleek, Luke
2005N-0345-EC870 - TEXT
Issue Areas/Comments
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.2>NO
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>NO
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 7.3.1.1>If FDA were able to allow these products for sale only in establishments already under FDA
jurisdiction e.g. pharmacies, medical clinics, enforcement would seem plausible. However, if FDA
allowed the marketing of this class of products by retailers not currently bound by FDA regulation, e.g.
mass marketers, enforcement would be tenuous.
B. If it could, would it be able to do so as practical matter and, if so, how?
<5: 7.3.2>Practicality would be dependent on the structure of the business entity allowed to offer these
items for sale.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 3.8.8, 8.6.4>A prescription product would assume the patient has had the benefit of a medical
examination and consultation of a willing physician and pharmacist.
An OTC product which could be acquired in a self service environment would necessarily carry the
responsibility to inform the patient of proper use, mechanism of action, and the dangers of not submitting
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themselves to routine medical examinations to detect diseases. In the case of emergency contraceptive
marketing, and despite the most comprehensive labeling, I believe that many young sexually active
women will not recognize the value of routine gynecologic exams. These women will likely never submit
themselves to routine gynecologic exams and public health will suffer.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.2.1>Two products could be packaged in a single package techniqe, only when a substantial review
of the impact of marketing the product over the counter would reveal that all other public health issues
would either improve of remain unchanged.
GENERAL
GENERAL
<8: 1.2.3>Over the counter status of any drug should require research to assure that public health will be
improved or at a minimum, not jeopardized by the OTC status. In my experience as a community
pharmacist, many women submit themselves to a gynecologic exam only when necessary to receive a
contraceptive prescription. Since many diseases and other health conditions are discovered and
consequently treated pursuant to routine exams, I believe public health will suffer from the otc status of
emergency contraceptives, regardless of age requirements.
COMMENT NUMBER - 2005N-0345-EC882
2005N-0345-EC882 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Vander Bleek, Peter
2005N-0345-EC882 - TEXT
GENERAL
See attachment
2005N-0345-EC882-Attach-1.DOC
ATTACHMENT:
To whom it may concern:
<1: 1.2.3>I am a concerned citizen. Allow me to preface my comments with the following information
from the web site of Barr Labs, the manufacturer of Plan B(R).
www.go2planb.com/ForConsumers/AboutPlanB/HowItWorks.aspx
"Plan B(R) is approved by the FDA and contains the hormone levonorgestrel, the same hormone in the
birth control pills that healthcare professionals have been prescribing for more than 35 years. The
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difference is that Plan B(R) contains a larger dose of levonorgestrel than the amount found in a single
birth control pill."
As are you, I am certain that this is an over-simplification of the issue. I ask you, would Barr Labs tell
prospective customers that an anticoagulant, Warfarin, which they also happen to sell, is safe because it is
only rat poison-the only difference being the dosage level? Certainly not, but Barr leaves this bit of
information out of its Warfarin literature. I infer that it would be too dangerous to Barr Labs for its
consumers and prospective consumers to realize one important thing about pharmacology: that the effects
of a drug therapy are often as dependent on the dosage level of a drug as they are on the drug itself.
In the above consumer information, Barr states that Plan B(R) simply "…contains a larger dose of
levonorgestrel than the amount found in a single birth control pill." In my opinion, Barr Labs and its
marketing team are attempting to capitalize on the public's lack of awareness of the importance of dosage.
In fact, the action of the drug is very much different from a "birth control pill." Note Barr's clever use of
information from its web site:
Plan B(R) works like a regular birth control pill. It prevents pregnancy mainly by stopping the release of
an egg from the ovary, and may also prevent the fertilization of an egg (the uniting of sperm with the
egg). Plan B(R) may also work by preventing it from attaching to the uterus (womb). It is important to
know that Plan B(R) will not affect a fertilized egg already attached to the uterus; it will not affect an
existing pregnancy.
It is important to note that the antecedent of "it" (highlighted in the third sentence) appears to be "egg."
"It," however, refers to a fertilized egg. This information was very cleverly worded by Barr to do nothing
but mislead the public. Whether one knows that life begins when a sperm meets an egg, or argues that it
begins at some other arbitrary point, it is clear that Plan B(R) does not work "like a regular birth control
pill," as stated by its manufacturer.
<2: 3.8.8>It is a certainty that the general public's understanding of the intricacies of how drugs act on the
body varies a great deal-from very little to expert. Not many of us have had advanced training in the
study of pharmacology or have a working knowledge of advanced chemistry. For this reason, I believe
that the average prospective consumer of this drug is vulnerable to this company's aforementioned sales
propaganda. I am certain that OTC approval of Plan B(R) would be tantamount to unleashing Barr Labs
and its "misinformation sales machine" on an unaware public.
At this time, the public is safeguarded by the knowledge, training and consultation of its doctors and
pharmacists. If Plan B(R) were to reach the OTC shelves, these safeguards will have been sacrificed-in
my opinion a risk to public health.
<3: 1.2.3>Please continue to take Barr Labs and their comments about Plan B(R) with the proverbial
"grain of salt." As you can see in the literature they present to the public, Barr is not above sacrificing
important information about their product as a means to an end: expanded sales of a product that is very
much different from traditional contraceptives. Based on Barr's current conduct, there is no indication
that FDA approval of Plan B(R) for OTC sales will spur their corporate philosophy-and consequently the
information they offer consumers-to change. In such a case, I predict an even more blatant campaign of
misinformation.
Being men and women of Science-and being charged with the awesome responsibility to safeguard public
health-it is incumbent upon you at the FDA to weigh the risks of this drug's effects on the general public.
I am certain that an OTC version of Plan B(R) will tout itself-as has its prescription counterpart-as a
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"regular birth control pill." This false information is a risk that our public simply cannot afford.
Based on these concerns, I urge the FDA to deny Plan B entry into the OTC market.
Respectfully,
Peter M. Vander Bleek
COMMENT NUMBER - 2005N-0345-EC895
2005N-0345-EC895 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Holden, Karen
2005N-0345-EC895 - TEXT
Issue Areas/Comments
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<1: 3.1, 3.8.3>If a there is evidence that a prescription drug poses a particular risk to a particular
subgroup of the population, then the FDA may impose added restrictions for that group, including
marketing the drug simultaneously as OTC and prescription. However, the definition of risk should
encompass only safety or efficacy of the particular medication, and should be based on accepted
evidence. Any other basis or concern used to deny access to medication to a partcular subgroup is beyond
the legitimate interest of the FDA.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.3.4>The confusion arises from FDA's seeming to ignore the advise of its professional staff and
instead to bow to political pressures from the religious right.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.5>Only if the rulemaking were based on legitimate concerns about the SAFETY and EFFICACY of
a particular medication in a particular subgroup. Rulemakings done for the sole purpose of social
engineering at the behest of religious concerns is insidious and likely unconstitutional. It would increase
confusion over the role of the FDA, and lead to lawsuits.
COMMENT NUMBER - 2005N-0345-EC896
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 375 of 415
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2005N-0345-EC896 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Guy, Katie
2005N-0345-EC896 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 7.5.3>If a drug has a limitation for one group of individuals and not another, being simutaneously
sold as a prescription and an OTC drug will open the door for those individuals the FDA has put the limit
on to easily obtain the drug illegally through a relative or friend and putting them in danger. I strongly
oppose this action.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 7.5.3>This would be extremely hard to enforce by law. Any GIRL 16 years or younger can easily
have a friend or relative purchase the drugh OTC for them. If, as a result of this act, the child fell ill the
FDA would be responsible.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<3: 8.5.4>This action would add even further confusion to the scenario. Having them sold in the same
package would make it virtually impossible to determine if the minor child had obtained the drug
lawfully, through a prescription.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<4: 9.1.1>In the circumstance of the drug Plan B it would be unequivocally inappropriate to do so!!
GENERAL
GENERAL
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<5: 1.2.3>I am adamantly opposed to the sale of 'Plan B' over the counter to anyone of any age. Your
letter referres numerous times to females 16 years old and younger as 'women', I would like to emphasize
that these are children, girls, not women. At the very most they are young ladies or young women. One
should be careful in his choices of words. 'Plan B' is a drug that can have serious consequences to anyone
taking it. This drug should always be taken under the care of a doctor if it remains legal. Hopefully, one
day soon, society will shift towards the view that drugs that cause abortions and end perfectly healthy
pregnancies should be made illegal. But until then this drug needs to be strictly regulated. Liberalizing it's
use will only harm women, not help them.
COMMENT NUMBER - 2005N-0345-EC9
2005N-0345-EC9 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Corder, Traci
2005N-0345-EC9 - TEXT
Issue Areas/Comments
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<1: 6.5.4>I feel it is unlawful to with hold certain medications to a subpopulations. They are either safe or
they aren't safe. There is no biochemical difference in this subpopulation.
COMMENT NUMBER - 2005N-0345-EC90
2005N-0345-EC90 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Townsend, Elisha
2005N-0345-EC90 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
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when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.1>With respect, I beleive the FDA has created this situation with it's previous decision which
denied over the counter access of EC because it felt that there were not enough studies proving the drug
was safe for those 16 and under. To approve the current application, would create a situation where a
completly safe drug has been denied to a section of the population. I can see issues of discrimination
arising. However that is not a reason to deny access to those who are 17 and older. My suggestion would
be to revisit the previous ruling and fully approve access. Short of that you must change your
interpretation to allow for the discrimination you have already set in place.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
Yes. It sould also allow the FDA to review a previous ruling when it creates this type of situation.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.5>There are other drugs that have age limits such a tobacco and alcohol. However both of those
have proven negative side effects, and are not also prescription.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.5>I'm not so sure. We are trying to change the rules so that our descrimination against young
women seems o.k. They are able to consent to their own reproductive healthcare, and thus should be able
to purchase this over the counter medication. If you start bending the rules, it opens up the flood gates as
you pointed out in your letter. Of course this contradicts my previous statements, but this whole situation
is contradictory.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.1>They could, but they should not.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.2, 8.6.3>IF you are planning on enforcing the legality of who can have it, you must have diferent
packaging and the pills should look different as well.
GENERAL
GENERAL
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What a pickle you have made. Just deny the whole thing so the public can really see where the FDA
loyalties lie. After all, you must know that many consider this pill to be an abortafacient.
COMMENT NUMBER - 2005N-0345-EC903
2005N-0345-EC903 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Kopp, Margaret
2005N-0345-EC903 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2, 3.8.8>No. The FDA is so thoroughly biased and under the influence of politics that any rule that
it makes at this time will be in the interest of politics, and not in the interest of good medicine, nor in the
interest of the public sector.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
This comment section appears to be identical to the one above it, except that there is a grammar error in
this one. They are both identified as the "1. A." comment, with very similar wording.
"A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?"
and
"A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?"
Please note that in the second "1. A." comment, in the following passage "when an active ingredient can
be simultaneously market in both a prescription drug product...", the appropriate verb should be
"marketed", not "market".
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B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2, 4.4.2>No. It is very clear that the FDA is making the interpretation that is preferred by White
House, without regard to actual safety and efficacy of the drug in question. I am not at all confused. I am,
however, deeply offended by the actions of the FDA, in hijacking this drug as part of a political
agenda.
C. If so, would a rulemaking on this issue help dispet that confusion?
If you are sensing confusion, it is probably due to the spelling errors on your website where comments
can be submitted. To help clear up the confusion, let me suggest to you that "dispel" is spelled d-i-s-p-e-l,
NOT d-i-s-p-e-t.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 7.5.3>No. The subpopulation in question would simply find a person who meets the preferred criteria
to obtain the OTC product for them.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes. A simple solution to this problem would be to require a prescription for young women age 16 and
under. They will then get an older friend to buy the drug for them, and everyone will be happy, sort of.
Young women are used to having their rights trampled, so they will not realize the extent to which they
have been denied their rights until they are much older.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.3.1>It depends on whether the written patient instructions accompanying the package could be
made clear and un-ambiguous under those circumstances.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<5: 9.1.1>If there were patient instructions that would apply to prescription use that do not apply to OTC
use, and this could not be made clear in the patient instructions, then it would be inappropriate to sell the
item in the same packaging.
GENERAL
GENERAL
<6: 8.9>Many OTC drugs are sold with clearly labelled instructions "under age two, ask your doctor", or
"under age 12 ask your doctor". I see no reason why this OTC drug could not be labelled in a similar
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fashion.
<7: 1.2.1>We should consider whether the prescription requirement for this drug should be removed
entirely. If it can be safely sold without a prescription, then clearly IT CAN SAFELY BE SOLD
WITHOUT A PRESCRIPTION.
Removing the prescription requirement for the drug would eliminate what appears to be a major source of
confusion.
COMMENT NUMBER - 2005N-0345-EC91
2005N-0345-EC91 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Hawkins, Susan
2005N-0345-EC91 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>I do not believe so.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<3: 6.2, 7.5.3>I don't see how it's possible. You talk of selling only to women. Yes, women will be the
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ones taking the drug, but a man may purchase the drug for his partner. You cannot know whether his
partner is 17+ or not.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<4: 8.5, 8.9>Yes, they can but to have any possibility of regulation you would probably need to have
different packaging. This brings up an issue of the possibility of a pharmacy running out of one type (Rx
vs. non) and not being able to sell the one they do have in its place. It can make inventory an issue.
Additionally you have pharmacists who refuse to dispense drugs of this nature to anyone.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
see comment above.
GENERAL
GENERAL
<5: 1.2.1>It's either safe or it isn't. It's been approved for Rx and appears to be safe enough to be OTC. I
don't think age should be a consideration here. This is not going to encourage promiscuity, but it may
prevent some unwanted/unnecessary pregnancies and the difficult decision/action of having an abortion.
This is a drug that is available in other parts of the world without this quandry. I'm not really certain what
our issue is.
COMMENT NUMBER - 2005N-0345-EC921
2005N-0345-EC921 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Aengst, Jennifer
2005N-0345-EC921 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 6.5.1>The FDA should determine that product can be both sold as a prescription and OTC. Even
though neither the FDA nor the pharmacies are able to regulate whether the consumer is within the age
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category that the drug is available for, the FDA's responsibility in this case is just to make
recommendations not necessarily to enforce them. The individual consumer still has rights.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 3.1, 3.8.1>Yes, the FDA should codify its interpretation of this act, so that it can address the
numerous cases of drugs ingredients that are present in both prescriptions and OTC sales.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.1>Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 5.1, 5.3.2>Yes it would but rulemaking needs to be flexible enough so that it can accomodate
particular states...certain states are more progressive than others, in terms of letting consumers determine
whether they can have access to medicine, that remains controversial in other states.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.2, 6.5.4>No I think that's an inappropriate use of the FDA's power. Targetting a particular
subpopulation is discriminatory...either the medicine is available OTC to everyone or it's not. It's
questionnable that the FDA would want to determine which population can have access or not. Either it is
available or not...education and warnings can certainly be there, recommendations are appreciated, but if
something is going to be available OTC, that means that the FDA has to let go of any sort of control of
who buys it.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
I'm not sure about that...
COMMENT NUMBER - 2005N-0345-EC93
2005N-0345-EC93 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Burns, Ben
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2005N-0345-EC93 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.3.3, 3.9.1>i dont see a problem with it, they already partially do it with naproxen, by having lower
doses in the over the counter drug aleve. it would allow cunsumers who could purchas it, as well as allow
organizations like planned parenthood, who could prescribe it to low income falmilies.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1>yes there is a lot of confusion over it.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.1>it probably would.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.5.4>it would acually be a kind of age descrimination. if the younger kids want it, because they are
having sex, wouldn't we want them to use it instead of them geting pregnant, and possily having more
burdens on the social services than there is now.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.6.2>no, it would cause confusion.
GENERAL
GENERAL
<6: 1.2.1>i think that if the morning after pill was available to women otc, there would be a lot of demand
for it, because people do some dumb things at times, like when they are drunk. also, say they are using
condoms to begin with, and it rips, this would be a product that would give them piece of mind knowing,
ok, i can still take this, and i wont get pregnant. they wont have to have all the worry and stress until they
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find out, ok, im not, or oh god, i am.
COMMENT NUMBER - 2005N-0345-EC94
2005N-0345-EC94 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Wurtz, Richard
2005N-0345-EC94 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>YES
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
YES
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>NO
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 4.2>NO
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<4: 6.2>NO
B. If it could, would it be able to do so as practical matter and, if so, how?
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<5: 7.2>NO
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.1>YES
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<7: 9.1.1>WHEN THERE IS AN AGE LIMITATION. THE SOURCE OF THE DRUG AS
PRESCRIPTION OR OTC IS THUS SKEWED AND PHARMACIES COULD VOUCH THAT THEY
SOLD IT PRESCRIPTION RATHER THAN AN OTC PURCHASE.
GENERAL
GENERAL
<8: 1.2.3>THE PARTICULAR DRUG IN QUESTION I.E. PLAN B SHOULD NOT BE SOLD OVER
THE COUNTER. THE MISUSE OF THIS DRUG AND ITS FORCEFUL USE IN MINORS WILL BE
WIDESPREAD. AS WITH TOBACCO AND ALCOHOL THE ABUSERS OF THIS DRUG WILL
PRIMARILY BE MINORS. THIS IS AN ABSOLUTELY RIDICULOUS PROPOSAL AND SHOULD
BE CONDEMNED. AS A PRIMARY CARE PHYSICIAN WHO WITNESSES THE MISUSE OF
OVER THE COUNTER DRUGS ON A DAILY BASIS, NOT TO MENTION THE MISUSE OF
PRESCRIPTION HORMONES, THE IDEA OF PLAN B GOING OTC IS FRIGHTENING. THIS
REGULATORY COMMITTEE SHOULD BAN THE OTC SALE OF PLAN B AS A PUBLIC
HEALTH DISASTER COULD ENSUE WITH ITS RELEASE. RICHARD P. WURTZ MD
COMMENT NUMBER - 2005N-0345-EC940
2005N-0345-EC940 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Mock, Suzanne
2005N-0345-EC940 - TEXT
Issue Areas/Comments
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
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<1: 3.8.3>This should be spelled out very clearly for practitioners and pharmacists, alike, so they cannot
misunderstand the language. Selling this product as both a prescription product and an OTC product
should not be much different from what is happening now with physician/pharmacist agreements
regarding many medications.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<2: 6.1>I believe this could occur. <3: 7.4.1>Pharmacists are law-abiding citizens like most
other people of this country. Handing out PlanB like candy is not ethical or lawful and most pharmacists
would not be willing to do this. Enforcing this law would not be an issue for this medication.
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.4.6>This could occur, as well. Already, pharmacists are allowed to dispense this medication with a
previous written consent from a licensed physician and later receive a written prescription. A
questionnaire for the patient wishing to receive this medication would not be impractical for a pharmacist
to go through with the patient.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.6.4>The same active ingredients that are sold both over-the-counter and by prescription, such as
ibuprofen, do not have the same packaging. It would be best for both legal and reasonable practices to be
sold under different packaging. This would make it easier for the pharmacist to differentiate between the
two products.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<6: 8.6.4, 9.1.2>I think having the same packaging for the medication would make the pharmacists' job
more difficult. I don't believe that it would be appropriate under any circumstances for this product to be
dispensed in the same packaging.
COMMENT NUMBER - 2005N-0345-EC95
2005N-0345-EC95 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Trubow, Marshall
2005N-0345-EC95 - TEXT
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Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes, <2: 1.2.1>me thinks you'r making a mountain out of a molehill with this
roundabout issue on whether to allow Plan B to be OTC. The FDA's subcommittee previously
recommended placing Plan B on the OTC list, only to have the political process intervene. There appear
to be many interested parties in this debate, but in reality it comes down to the prolife vs abortion rights
advocates, and it is clear that science is the loser when these issues become politized as this one has. If
women's health were truly the issue, the data would say this is a "no brainer". It's safety has been shown,
and if we really want to avoid having our patient's chose between an abortion or an unwanted pregnancy,
then Plan B should be available OTC. The packaging is not the same as the already approved prescription
items, and should not preclude this from being available
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<3: 3.1, 3.9.1>Yes-you have already done this. You can obtain Ibuprofen as an OTC 200 mg tablet, but it
is also available as a prescription in 600 and 800 mg doses.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<4: 4.1>Yes
C. If so, would a rulemaking on this issue help dispet that confusion?
<5: 5.2>Doubtful. We don't need more rules- we need some basic common sense to prevail, and have the
politicians stay out of this.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<6: 6.7>Would it really need to?
COMMENT NUMBER - 2005N-0345-EC951
2005N-0345-EC951 - STRUCTURED DATA ELEMENTS
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Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Brass, Kathryn
2005N-0345-EC951 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.2>No. <2: 2.1, 3.8.4>The FDA?s interpretation of this rule has, up until this decision, been
consistent for many years; care needs to be taken that political pressures are not entered into the
interpretation, but the rule itself is straightforward. <3: 1.2.1>Furthermore, the
unnecessary process of codifying new rules will only prolong Plan B coming to market as an over-the-
counter medication. <4: 3.9.1>There are numerous examples of discretionary drugs (nicotine,
alcohol) that are marketed to/available only to subpopulations; they provide more than enough precedent
to move forward with the ruling without codifying it.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<5: 4.4.2>The only confusion resulting from the FDA?s interpretation of this section of the act stems
from the FDA?s deviation from precedent established by our scientific understanding of drug effects on
women of reproductive age. <6: 1.2, 4.5>In every previous ruling, the FDA has considered
women of reproductive age as one group when looking at the safety and efficacy of a product. The
arbitrary separation here into ?adolescent? women and ?adult? women is unsupported by the scientific
literature, particularly in light of studies which find no differences in the frequency or risk of unprotected
sex in young women provided emergency contraception in advance. On the contrary, these teens are more
likely to use emergency contraception with unprotected coitus, and to use it earlier after the event, making
it more effective. In addition, no decreases have been seen in consistent condom use in the teens that had
unrestricted access to emergency contraception. Furthermore, studies in both the US and the UK indicate
that teens are not more likely to use emergency contraception as a regular birth control method, nor are
they more likely to engage in risky sexual behavior as a result of improved access to the drug.
<7: 1.2, 10>1. Raine T, Harper C, Leon K, Darney P. Emergency contraception: advance provision in a
young, high-risk clinic population. Obstet Gynecol. 2000;96:1?7.
2. Gold MA, Wolford JE, Smith KA, Parker AM. The effects of advance provision of emergency
contraception on adolescent women's sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol.
2004;17:87?96
3. Glasier A, Baird D. The effects of self-administering emergency contraception. N Engl J Med.
1998;339:1?4
4. Ellertson C, Ambardekar S, Hedley A, Coyaji K, Trussell J, Blanchard K. Emergency contraception:
randomized comparison of advance provision and information only. Obstet Gynecol. 2001;98:570?575
5. Jackson RA, Bimla Schwartz E, Freedman L, Darney P. Advance supply of emergency contraception.
Effect on use and usual contraception?a randomized trial. Obstet Gynecol. 2003;102:8?16
6. Belzer M, Yoshida E, Tejirian T, Tucker D, Chung K, Sanchez K. Advanced supply of emergency
contraception for adolescent mothers increased utilization without reducing condom or primary
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contraception use. J Adolesc Health. 2003;32:122?123
7. Blanchard K, Bungay H, Furedi A, Sanders L. Evaluation of an emergency contraception advance
provision service. Contraception. 2003;67:343?348
8. Cicely Marston, Howard Meltzer, Azeem Majeed. Impact on contraceptive practice of making
emergency hormonal contraception available over the counter in Great Britain: repeated cross sectional
surveys. BMJ, doi:10.1136/bmj.38519.440266.8F (published 11 July 2005)
C. If so, would a rulemaking on this issue help dispet that confusion?
<8: 5.2, 5.4.1>Rulemaking on this issue is unlikely to help dispel the confusion mentioned above, as the
confusion stems largely from the FDA?s arbitrarily redefining the population of reproductive-age women,
and moving away from precedent, not from an incomprehensible or ill-defined law.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<9: 6.1, 6.6.3>As mentioned above, such limitations on alcohol and tobacco are widespread and
enforceable. <10: 6.6.1>State and Federal bodies alike have engaged in enforcing laws
such as the one the FDA proposes, and it would not be outside the legal powers of the FDA to both
impose and enforce this law.
B. If it could, would it be able to do so as practical matter and, if so, how?
<11: 7.4.5>As a practical matter of enforcement, a fines system could be set up to punish those who
violate the distribution laws that result from this ruling. <12: 7.4.4>Requiring photo ID from
consumers for sale of such products would be an obvious first step. <13: 6.6.1>Precedent for
this in the pharmaceutical industry already exists in many states ? the sale of over-the-counter
pseudoephedrine is now often restricted to those over 18 and requires showing a photo ID.
<14: 7.4.3>Periodic ?stings? with underage-looking consumers (similar to those performed in bars and
convenience stores) would provide sufficient deterrent for selling to ?minors.? <15:
7.5.4>While the issue of older friends and acquaintances buying the products for minors remains, this is a
challenge for practical enforcement of any law that subdivides a population into those who can and cannot
purchase certain products.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<16: 8.1, 8.4.1, 9.1.1>One might conclude that the two products should not be sold in the same package
in order to differentiate those purchased with a prescription and those purchased over the counter.
However, the likelihood that a young teen will be caught standing on the street corner with her non-
prescription-style package of emergency contraception is low, and the idea is absurd. There is no logical
reason for these two products to be packaged differently, as the dosage and usage are exactly the same.
<17: 3.9.1, 8.8>Claritin is currently offered over the counter, but some patients
continue to obtain prescriptions in order to purchase it at a reduced price with a co-pay, and these
packages do not differ. <18: 8.4.1>In fact, separate packaging might encourage
consumers to think (erroneously) that the two are different or should be used differently.
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B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
N/A
GENERAL
GENERAL
<19: 1.2.1, 2.1>This latest delay in bringing Plan B to the over-the-counter market is absurd and flies in
the face of scientific evidence-based medicine. The previous decision on Plan B was made with complete
disregard for the wealth of literature regarding how Plan B might be used. This current decision on Plan B
has made a regulatory mountain out of a molehill in an attempt to impose new rulemaking and delay the
advent of Plan B as an OTC drug even further, despite its proven safety and efficacy.
The entire purpose of the Food and Drug Administration is to serve as the unbiased evaluator of drugs and
devices ? to mediate and mitigate the influences of all parties who might want to take advantage of the
consumer for their own gain, or who might unwittingly impose significant risks on any given patient
population. In the current climate, the FDA cannot afford to continue to lose the public trust by
politicizing this issue. Already the public is wary of the FDA?s commitment to their health, and indefinite
foot-dragging on the issue of emergency contraception does not do the FDA?s public image any favors.
As a medical professional in training, I am ashamed that such obvious political interference should have a
place at the FDA. The governmental agency designed to protect the American public with regard to what
they put in their bodies should be above such games. By proxy, health care providers, too, will bear the
brunt of patients? mistrust in the FDA ? we must prescribe medications ?approved? by the FDA, and
patients will wonder how confident we can really be about those drugs.
Move forward on the Plan B application, and dispense with the politics. The resignation of Susan Wood is
evidence enough that something is drastically wrong at the FDA, and the public needs reassurance that
the agency will put science over politics, public interest over political agenda. Plan B belongs on drug
store shelves where it can be utilized to reduce the number of unintended pregnancies in the US, a number
that far exceeds any other country in the developed world. As a physician in training, I implore the FDA
to reconsider this ruling and move forward on the Barr application.
COMMENT NUMBER - 2005N-0345-EC96
2005N-0345-EC96 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Etter, Eleanor
2005N-0345-EC96 - TEXT
Issue Areas/Comments
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1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 1.2.2>The real question is whether Plan B is safe and effective for over-the-counter use by women
over the age of 16. FDA's own scientists determined that to be the case before the first delay.
Consequently, the FDA should approve such use immediately. Then, if the FDA would like to initiate a
rulemaking to codity its interpretation of section 503(b) and if that is the most important way for the FDA
to spend its resources right now, it should do so. Any other course of action would unnecessarily subject
women who would choose to use Plan B to higher expenses and more inconvenience. And, not
insignificantly, it would undermine the trust of the majority of Americans in the FDA.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
<2: 1.2.2>It's already clear that at least in the case of Plan B, that it should be allowed.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<3: 4.5>I would think people are wondering whether the FDA still adheres to its policy of basing
decisions on science as opposed to ideology. When the FDAs scientists recommend one course of action
and the agency acts against that recommendation, the public's trust of the agency is understandably
undermined.
C. If so, would a rulemaking on this issue help dispet that confusion?
<4: 2.1, 5.2>No. Using "rulemaking" to delay approval would not help.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.6.3>Assuming making a product available to a subpopulation is legal, the enforcement would be
fairly straightforward. And, certainly there are currently drugs available that are for use by adults only.
The marketing of those drugs does not seem to cause a problem. Currently, almost all pharmacies sell
products which only a subpopulation can purchase (eg, tobacco products) and they do it very effectively.
Also, alcohol is currently available to adults only and it is effectively sold to only a subpopulation with
far less supervision that there would be in a drug store.
B. If it could, would it be able to do so as practical matter and, if so, how?
<6: 7.4.4>Similar to alcohol sales: If the customer appears to be below a certain age (perhaps 26 to give a
10 year margin), they would be required to show proper photo ID. Alcohol sales are controlled fairly
effectively in such a manner and without the oversight of a pharmacy. If this works for alcohol, a
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substance which can cause death in the use in sufficient amounts and is subject to abuse, then the
marketing of Plan B, which young people would get no special abuse pleasure from, could be handled in
the same fashion.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<7: 8.1, 8.4.1>Of course. Doing otherwise would cause unnecessary expense to women.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.2.2, 9.3>None. Although, it would be unethical to charge more for Plan B dispensed by prescription
rather than over-the-counter.
GENERAL
GENERAL
<9: 1.2.1>Choosing to end an unplanned pregnancy is surely one of the most difficult decisions a woman
ever has to make. Unfortunately, every day many women are forced to make that decision. Easy and low
cost access to Plan B will help spare hundreds or perhaps thousands of women that awful dilemma and
further reduce the incidence of abortion in our country. Further delay in its approval not only causes
women unnecessary expense and inconvenience but serves to increase health risks for them if they choose
to end an unintended pregnancy with an abortion. Choose science over ideology - release the stranglehold
on Plan B and approve its over-the-couter use now.
COMMENT NUMBER - 2005N-0345-EC97
2005N-0345-EC97 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Brakman, Anita
2005N-0345-EC97 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 2.1>While I fear the rulemaking process is just another delay tactic regarding the approval of Plan B,
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 393 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 385
if this will help women access this important medication, than the process should begin as soon as
possible.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
drug product?
No. The ruling only has to take into account the case at hand, and not all future drugs. Additionally, if and
when studies show Plan B safe and effective for women under 16, the medication should become
available to them as well.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.2>No.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.2>No. <4: 5.4.2>There is no confusion, only politically motivated delay.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.1>Yes. <6: 7.4.4>Such age limitations are already in place for purchasing cigarettes and
alcohol. Similar age limits exist for everything from renting a car to voting.
B. If it could, would it be able to do so as practical matter and, if so, how?
<7: 7.4.4>This could be simply enforced by asking consumers for proof of age and identification.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<8: 8.6.2, 8.6.3>It is advisable to use different packaging to help ease enforcement and prevent mistakes
in distribution.
GENERAL
GENERAL
<9: 1.2.1>Dear Commissioner Crawford, I am deeply disappointed that the decision on whether to make
Plan B, emergency contraception, available in pharmacies has once again been delayed. As the FDA's
own panel has decided that this medication is safe and effective, I can only conclude that this delay is
politically motivated, and not tied to any real concerns over women's health. I called my Senator and
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 386
asked her to block your confirmation until you agreed to decide this matter, and I was pleased at the
earlier announcement that a decision was forthcoming on September 1st. I took this to mean that you
would finally make a decision, and hopefully one based on the FDA's own recommendations. Today
Secretary Leavitt took the opportunity to mince words, saying that only "action" was promised, and that a
delay is such an "action." Additionally, while I believe this medication should be available to all women,
including those under 17, it is ridiculous to me that any question comes up over how to ensure Plan B is
distributed only to those who are of legal age. I have bought cigarettes in pharmacies in the past, and
never found it to be a confusing or difficult process to enforce the age limit by producing identification.
To me, this is just another empty line of reasoning.
Emergency contraception is a safe, effective medication that could prevent unintended pregnancies and
abortions in this country, yet it is being kept from women under the guise of concern for their own safety.
This is a medication that is more effective the sooner it is taken, and getting a prescription is a major
barrier to this process. Most women do not even have a primary care physician, and most physicians wait
times for appointments are up to a week. Even women who use hotlines like 1-800-NOT-2-LATE have
experienced difficulty when they have prescriptions called in when pharmacists then refuse to honor
them.
I can see this delay only as an effort to police women's sexuality, and pander to abortion opponents in the
radical right. Don't you agree that we should all try to prevent unintended pregnancy in the first place?
Please make your decision soon. Please decide based on evidence for safety and efficacy, and please stop
making excuses and delays.
Sincerely,
Anita Brakman
712 Sackett St
Apt 1F
Brooklyn, NY 11217
<10: 10>Croxatto, H.B. et al., 2004. Pituitary-ovarian function following the standard levonorgestrel
emergency contraceptive dose or a single 0.75-mg dose given on the days preceeding ovulation.
Contraception 70(2004): 442-450.
<11: 10>De Santis, M. et al., 2005. Failure of the emergency contraceptive levonorgestrel and the risk of
adverse effects in pregnancy and on fetal development: an observational cohort study. Fertility and
Sterility 84(2), August 2005.
2005N-0345-EC97-Attach-1.PDF 2005N-0345-EC97-Attach-2.PDF 2005N-0345-EC97-Attach-
1.PDF 2005N-0345-EC97-Attach-2.PDF 2005N-0345-EC97-Attach-1.PDF 2005N-0345-EC97-
Attach-2.PDF 2005N-0345-EC97-Attach-1.PDF 2005N-0345-EC97-Attach-2.PDF 2005N-0345-
EC97-Attach-1.PDF 2005N-0345-EC97-Attach-2.PDF 2005N-0345-EC97-Attach-1.PDF 2005N-
0345-EC97-Attach-2.PDF 2005N-0345-EC97-Attach-1.PDF 2005N-0345-EC97-Attach-2.PDF
2005N-0345-EC97-Attach-1.PDF 2005N-0345-EC97-Attach-2.PDF
COMMENT NUMBER - 2005N-0345-EC98
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 395 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 387
2005N-0345-EC98 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Keys, Lori
2005N-0345-EC98 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.8.4, 3.9.1>As a pharmacist and public health practitioner, I do not see where the confusion lies.
According to information available at 21CFR Part 310 for Docket 2005N-0345, the current interpretation
of the Act includes a differentiation between OTC and Rx drugs by indication (among other things,
including strength, dosage form, and route of adminstration). The meaningful difference in the case of
Plan B is that the OTC product is indicated for adults; the Rx product is indicated for patients 16 years of
age and under. To me, that is the same as saying that meclizine is safe for use for motion sickness OTC
but requires supervision for use for vertigo. Plan B is safe for use by adults but requires supervision when
used in minors. The fact that the dose is the same for each population is immaterial. These are clearly
different populations, thus justifying an OTC and Rx label.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<2: 4.1, 4.3.4>Apparently, there is confusion since the FDA chose not approve Plan B for OTC use for
adults.
C. If so, would a rulemaking on this issue help dispet that confusion?
<3: 5.3.2>Only if it codifies that intended population is a meaningful clinical difference that can be used
to distinguish OTC and Rx status of a drug.
2
B. If it could, would it be able to do so as practical matter and, if so, how?
<4: 7.4.1, 7.4.4, 7.4.6>Pharmacies could be required to keep Plan B behind the counter. Women 17 years
of age and older could approach the pharmacist for access to the drug. The pharmacist could check ID,
create a permanent record of the transaction (similar to recording an oral prescription from a physician
onto paper), and file the information with other pharmacy records. The only difference would be that no
prescription would be required for adult patients. If the FDA wanted to monitor compliance, there would
be a paper trail for every sale of Plan B.
3
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 396 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 388
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<5: 8.1, 8.3.1>Yes, the standard warning that states that it is a violation of Federal Law to sell the item
without a prescription could be modified to indicate the distinction between the two populations.
GENERAL
GENERAL
<6: 3.8.2>Pharmacists are well-educated, compentent healthcare professionals and there is no reason to
believe that having a pharmacist control access to Plan B (allowing sale without a prescription for women
17 years of age and older, while requiring a prescription for younger women) would not work to protect
the public's health. <7: 6.6.3> If alcohol and cigarettes can be sold in this country based on age
restrictions, then there is no valid reason to prohibit the OTC sale of Plan B to adult women.
<8: 2.1>The stonewalling by the FDA needs to stop. As a woman and as a pharmacist, I am offended by
the delay tactics surrounding a drug that actually prevents abortions, and has been used safely and
effectively by thousands of women worldwide for many years.
COMMENT NUMBER - 2005N-0345-EC99
2005N-0345-EC99 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Stockton, Melissa
2005N-0345-EC99 - TEXT
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding
when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC
drug product?
<1: 3.1>Yes. <2: 3.8.3>More emphasis needs to be placed on one's ability to make and be
responsible for decisions reguarding their own health. People usually become more mature with age and
may not use an OTC wisely when younger. One should be able to make a informed decision with
information contained or distributed with the medicine.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding
when an active ingredient can be simultaneously market in both a prescription drug product and an OTC
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 397 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 389
drug product?
<3: 3.1>yes.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
<4: 4.2>No.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product
available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a
matter of law?
<5: 6.7>I feel there should only be a limit if the product would become dangerous after (x) number of
doses.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may
the different products be legally sold in the same package?
<6: 8.2>No,<7: 8.6.3> to discourage buying and redistributing, they should be in different
packages.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be
inappropriate to do so?
<8: 9.1.2>I feel the best case scenario would be to have the packages differ. It would simply cause the
fewest problems.
COMMENT NUMBER - 2005N-0345-EMC166
2005N-0345-EMC166 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Dalton, Mike
2005N-0345-EMC166 - TEXT
From: mike.dalton@nokia.com
Sent: Friday, September 16, 2005 1:35 AM
To: Dockets, FDA
Subject: 2005N-0345
<1: 3.2, 3.8.8>1. Should the FDA create and define a regulation to allow for a drug to be available both
with a prescription and without?
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 398 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 390
No. I believe in practice it would be ineffective and easily circumvented.
<2: 6.6.3>2. Does the FDA have the authority or ability to enforce restricting a drug from a subpopulation
when it would be available to the larger population?
Two examples of this are alcohol and tobacco. The laws around restricting the sale of these two drugs are
largely failing, so I would say the FDA has little ability to enforce this as a regulation.
<3: 1.2.3>3. Can a drug that is approved both with a prescription for some and without a prescription for
others have the same packaging, or would it require different warning labels and instructions?
That is a minor point in a very serious discussion that, in my opinion, sets the tone for how our society
views relationships and responsibility. The message this drug sends to our youth about the sanctity of life
is extremely disheartening. The results I have seen from Europe make it quite clear we are a stronger
country without this on store shelves where our school age children will essentially have easy access
through their older friends or siblings. We need to make the decision that protects our youth, and giving
this drug to them doesn't do that.
Thank you,
Mike Dalton
COMMENT NUMBER - 2005N-0345-EMC355
2005N-0345-EMC355 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Temple, Jennie
2005N-0345-EMC355 - TEXT
From: no-reply@erulemaking.net
Sent: Sunday, October 30, 2005 10:44 AM
To: Dockets, FDA
Subject: Public Submission
Please Do Not Reply This Email.
Public Comments on Drug Approvals: Circumstances Under Which an Active Ingredient May Be
Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product:
Title: Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously
Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product FR Document
Number: 05-17390 Legacy Document ID:
RIN:
Publish Date: 09/01/2005 00:00:00
Submitter Info:
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 399 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 391
First Name: Jennie
Last Name: Temple
Category: Consumer Group - B0001
Organization Name:
Comment Info:
General Comment:Food and Drug Administration
Docket No. 2005N-0345
Response to Advanced Notice of Proposed Rulemaking
<1: 3.1, 3.3.1>The current definition of a prescription drug is found in the Federal Food, Drug, and
Cosmetic Act. Prescription drugs, as explained in the act, are withheld form public consumption and
regulated due to the implications that misuse of said drug might have. Failing to expressly define an over
the counter drug can be viewed as an inherent flaw of the act, because making assumptions, like the
understood definition of an over the counter drug, can be dangerous. Due to the language of section
503(b), the FDA is facing a dilemma of whether or not to initiate a rulemaking to possibly permit the sale
of a substance both over the counter and by prescription. The FDA should definitely begin a rulemaking
process to clearly define the circumstances under which identical drugs can be sold in different
arenas.
<2: 3.8.1, 3.8.3, 5.1, 5.3.2>The FDA should initiate the rulemaking process to determine whether or not a
single substance can be marketed simultaneously as both a prescription drug and an over the counter one.
Carrying out the rulemaking process for such a decision would not only clarify the provisions of the act,
but it will also establish clear guidelines for drug vendors and manufactures to follow when introducing a
new product. The rulemaking process, by soliciting comments, would allow the decision to be based on
public opinion rather than simply the will of the drug and pharmaceutical companies mentioned above.
Initiating a rulemaking for this issue is necessary, because the language of the current rule does not
expressly mention the conditions under which a substance can be simultaneously manufactured in two
different markets.
<3: 7.4.1>Requiring that the drug be only available by prescription to a particular subpopulation is a
practical way to ensure a drug?s safe usage and administration. Using age as a criterion is typically
socially acceptable, as is the case with tobacco products, and the application and enforcement of such a
law could be easily carried out. For example, a law requiring that recipients of the Plan B contraceptive if
under the age of seventeen obtain a prescription could be easily enforced by placing the burden on the
pharmacists themselves. The drug could be kept behind the counter, like many over the counter drugs
commonly are, and all someone would have to do to obtain the drug is ask the pharmacists for it. <4: 7.4.4>A simple identification check, like ones done with tobacco products, would ensure that
the recipient of the drug was the proper age to not need a prescription. Women under the age of
seventeen would then only be able to receive the drug under the supervision of a licensed practitioner
with little extra effort in the way of enforcement.
<5: 8.1, 8.4.1, 9.2.1, 9.3>If the potency and active ingredient are identical for both the over the counter
and the prescription versions, then it is perfectly acceptable, if not essential, to market them in the same
packaging. The fact that age stipulations are placed on the avenues through which a person can obtain the
drug should have no effect on the final product that is received. The same drug, packaging included,
should be available equally to all women regardless of the method used to obtain it. If the packaging
were changed for the over the counter version, then there would be speculation that the drug is in some
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 400 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 392
way different from the one only available by prescription. It would be inappropriate, however, to market
the same drug in identical packaging but the charge a considerably higher price for one version than is
being charged for the other. For example, inflating the price of the prescription version of a drug would
unfairly restrict its use by the subpopulation that is already required to pay for a doctor?s visit in order to
receive a prescription. On the other hand, it would be inappropriate to ask a considerably higher price for
the over the counter version because it would deter women from choosing that avenue; instead, they
would simply get a prescription and pay the lower price. Both versions of a drug, prescription and over
the counter should be marketed in identical packages; however, with similar products and packaging
should come a similar price as well.
<6: 4.1, 7.4.4, 8.1>Initiating the rulemaking process to revise and clarify the Federal Food, Drug, and
Cosmetic Act would be a beneficial move for the FDA. There is considerable confusion regarding the
interpretation of whether a drug has to be only sold in one venue, or whether it is possible for
circumstances to exist were marketing the drug as both over the counter and prescription is the most
practical approach. Imposing age restrictions on the purchase drugs, such a Plan B, is the easiest way to
ensure that the drug is safely administered. Requiring identification verification from women purchasing
the drug over the counter limits underage sales, and shifts the burden of enforcement from the FDA and
doctors to the pharmacist themselves. The packaging of both versions should be identical, as should the
price of the drug. All of these topics should be addressed by the FDA by initiating a rulemaking to
specifically clarify interpretation of section 503(b), and to establish specific guidelines when a drug can
be simultaneously marketed as prescription and over the counter.
COMMENT NUMBER - 2005N-0345-EMC368
2005N-0345-EMC368 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Syed, Misbah
2005N-0345-EMC368 - TEXT
From: no-reply@erulemaking.net
Sent: Sunday, October 30, 2005 5:15 PM
To: Dockets, FDA
Subject: Public Submission
Please Do Not Reply This Email.
Public Comments on Drug Approvals: Circumstances Under Which an Active Ingredient May Be
Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug
Product:========
Title: Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously
Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product FR Document
Number: 05-17390 Legacy Document ID:
RIN:
Publish Date: 09/01/2005 00:00:00
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 401 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 393
Submitter Info:
First Name: Misbah
Last Name: Syed
Category:
Organization Name:
Comment Info: =================
General Comment:To the Food and Drug Administration (FDA) in reference to Docket No. 2005N-0345,
a dual approval is needed for both prescription and over-the-counter pharmaceuticals on the basis of
circumstances under which an active ingredient maybe simultaneously marketed. <1: 3.1, 3.3.3, 3.9.1,
4.1, 5.1>My comment to this advance notice of proposed rulemaking is that the FDA should consider that
in certain circumstances, a drug should be marketed both as prescription and over-the-counter. I will
address this concern by answering the following questions provided by the Food and Drug
Administration, to clarify that yes, a drug can be marketed for both prescription and over-the-counter use.
I will also provide arguments for what position the FDA use in rulemaking and what the FDA should
incorporate in any proposed rule.
The FDA should initiate a rulemaking code to clarify the interpretation of section 503(b) of the act
regarding when an active ingredient can be simultaneously marketed in both a prescription drug and over-
the-counter drug form because this section only uses the Federal standard classifying drugs as either
prescription or over-the-counter. It also defines what a prescription drug is, ?a drug intended for use by
man which because of its toxicity or other potential harmful effect, or the method of its use, or the
collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner
licensed by law to administer such drug?. This section does not define over-the-counter drugs. It explains
that whatever drug does not meet the standards to make it a prescription drug, is classified as over-the-
counter. This section only classifies a drug to be prescription or over-the-counter, but in certain
circumstances, the FDA has interpreted certain drugs with the same active ingredients to be marketed as
both prescription and over-the-counter. For example Meclizine, which is a prescription for vertigo, but for
over-the-counter purposes? It handles nausia with motion sickness. Also Nicotine products like inhalers
and nasal sprays, which are prescription drugs, but gums and patches are considered over-the-counter. It
brings significant confusion regarding the FDA?s interpretation of section 503(b) because other products
like Plan B which is a mourning-after pill is also over-the-counter, but to women 17 and older, otherwise
it would be a prescription to those women younger than 17. The section clearly does not define rules
about age limits and the agency has not figured out how to prevent younger teenagers from gaining access
to the pill. It would then be necessary for the FDA to propose a rulemaking solution for this issue to help
dispel the confusion.
<2: 6.1>If the FDA did limit the sale of an over-the-counter product to a particular population by making
the product available to the people in prescription form only, the FDA would be able to enforce such a
limitation because they can set standards to a targeted population. For instance, Plan B can be over-the-
counter to women 17 and older, but prescription for women younger than 17. The practitioners can also
take into consideration with the consent of parents of women younger than 17, if they should be allowed
to use such product, even if some argue that it will make teenagers think that sex is appropriate.
<3: 8.9>If it was legal to market the same active ingredient as both a prescription and over-the-counter
product, it should then also be able to be sold legally in the same package recognizing that one is over-
the-counter and the other is prescription. However, it would be inappropriate to sell them in the same
package, like Plan B or even H2 blockers, that contain over 300 mg to relieve ulcers. Some might
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 394
consider this inappropriate, but they could still be prescription or over-the-counter, just in separate
packages.
<4: 2.2, 3.8.1>Considering all the options presented and explained, one might say that ?the key
distinction in these examples is that there is some meaningful difference between the two products
(indication, strength, route of administration, dosage form) that makes the prescription product safe only
under the supervision of a licensed practitioner?. This just might be the case, but if one simultaneously
marketed both prescription and over-the-counter with the same ingredient, he or she brings more options
to some consumers. For example people who may not be able to afford prescription drugs and they either
do not have insurance, or their insurance may not cover their product. This is why it is important for the
FDA to setup an Advance Notice of Propose rulemaking to resolve the issue of circumstances under
which an active ingredient maybe simultaneously marketed, in both a prescription and over-the-counter
form.
COMMENT NUMBER - 2005N-0345-EMC373
2005N-0345-EMC373 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Tadeo, Peter
2005N-0345-EMC373 - TEXT
From: no-reply@erulemaking.net
Sent: Sunday, October 30, 2005 7:29 PM
To: Dockets, FDA
Subject: Public Submission
Please Do Not Reply This Email.
Public Comments on Drug Approvals: Circumstances Under Which an Active Ingredient May Be
Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product:
Title: Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously
Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product FR Document
Number: 05-17390 Legacy Document ID:
RIN:
Publish Date: 09/01/2005 00:00:00
Submitter Info:
First Name: peter
Last Name: tadeo
Category:
Organization Name:
Comment Info:
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 403 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 395
General Comment:comment for advance notice of proposed rulemaking (docket No. 2005-0345) attached
ATTACHMENT:
Peter A. Tadeo
2388-A Lawrenceville Hwy
Decatur, GA 30033
Docket No. 2005-0345
<1: 2.1>The Advanced Notice of Proposed Rulemaking (Docket No. 2005N-0345) by the FDA on
whether an active ingredient may be simultaneously marketed in both a prescription drug and an over-the-
counter drug should be looked at in many different perspectives. Rulemaking for this topic has been
postponed and disregarded for far too long, and the necessity for rulemaking starts with comments from
the American public.
<2: 3.3.3>Section 503(b) of the Durham-Humphrey Amendment does not simplify the confusion of what
is considered an OTC drug and should be changed for drugs to be sold both in the OTC and in the
prescription market. <3: 3.3.3>Regulations should be set in a practical manner, and many
current drugs that are only available as prescription could be sold to the public without the supervision of
a practitioner. When it comes down to this heavily debated topic the main question is: whether people can
inform themselves on the product that they are consuming.
<4: 3.8.3>One of the risks of making more dugs over-the-counter is the threat of abuse of prescription
drugs. Over history humans have always seen the beneficial and negative effects of decisions made by
governments, whether it is war, laws, or policy. In some circumstance there are people who will
constantly decide to abuse a great event, or in this case medicine, and exploit its contribution to many.
Currently drugs containing the same active ingredient but with a smaller dosage are sold as OTC, and the
more potent dosage is sold as a prescription product. Though, the smaller OTC dosages are still abused
by addicts. For example, Ibuprofen is sold OTC at under 400mg, but one could consciously take more of
the dosage prescribed on the label. The person taking this drug is knowledgeable about the side effects
that this drug will have and making it only prescription should not be implemented because of that small
population that chooses to misuse that medicine. Regulation is the option that one should look at when
promulgating new policies for OTC drugs.
<5: 7.4.4, 7.4.5>The United States of America is known as the land of the free and of opportunity. In the
early years of America our forefathers constructed the constitution to provide freedom from a centralized
government. Though, without regulation and laws this country would be in shambles. Certain medicines
with great potential for harm should always be monitored. For example, Hydrocodine should never be
sold in high dosages to the public because of the possibility of abuse. Setting an age restriction for OTC
drugs should be enforced more heavily. One way would be to force pharmacies to check ID for the
purchase of the drug and if they broke this law, a certain number of times, they should be penalized in
proportion to the transgression.
<6: 1.2.2>One of the main drugs that will be affected by the creation of a policy toward dual approval for
prescription and OTC pharmaceuticals would be the Plan B pill. This emergency contraception drug
should be sold as over the counter to people over the age of 17 and as prescription to those under that age
requirement. One of the arguments for not selling it as an OTC drug is that it would increase the
possibility of premarital sex. Young people have been having sex since the times of Romeo and Juliet
and making this drug mare readily available will not increase what is naturally in the minds of
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 396
adolescents. <7: 7.4.6>Regulation for this drug could be used by creating a data base for any
drug that has a high chance of abuse and have that person sign before they receive the pharmaceutical
product. Drug stores could have this database on file to observe the number of times a person has used a
particular drug so they could be aware of any type of misuse.
<8: 7.4.3>Section 503(b) should be changed to state that drugs that have shown or show a high possibility
of abuse should be monitored more strictly than those drugs that have a lower threat of misuse. The drugs
of high abuse rates can be seen by looking at past records. Regulating the purchase of pharmaceutical
products can work if a system is well organized to do so.
<9: 3.8.3>Promulgating policy for prescription drugs should be viewed as a step forward in the right
direction. Increasing the introduction of prescription drugs into the OTC market will boost competition
and make pharmaceutical products more of a free market. This will in turn lower prices for those that can
not afford to obtain drugs. Those with health insurance can still go to there doctor and receive the drug
by prescription for only a co-payment or choose to buy it over-the counter. US citizens have the right to
know what they are taking and informing the public about the drugs they are consuming would have to be
increased. Accessible and affordable drugs are the answer to repairing the tarnished prescription drug
system.
<10: 3.8.3>The FDA needs to approve rulemaking for the sell of an active ingredient in both in a
prescription drug product and an over-the counter product so that all American citizens can receive
medical help for any illness or problem they may have. A government's job is to keep order and to do
what is best for the good of the people.
COMMENT NUMBER - 2005N-0345-EMC374
2005N-0345-EMC374 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Thames, Samuel
2005N-0345-EMC374 - TEXT
From: no-reply@erulemaking.net
Sent: Sunday, October 30, 2005 7:33 PM
To: Dockets, FDA
Subject: Public Submission
Please Do Not Reply This Email.
Public Comments on Drug Approvals: Circumstances Under Which an Active Ingredient May Be
Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product:
Title: Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously
Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product FR Document
Number: 05-17390 Legacy Document ID:
RIN:
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 405 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 397
Publish Date: 09/01/2005 00:00:00
Submitter Info:
First Name: Samuel
Last Name: Thames
Category:
Organization Name:
Comment Info:
General Comment:<1: 3.1, 4.1, 6.1, 8.1>In regards to the FDA?s request for comments on the advance
notice of proposed rulemaking for the simultaneous marketing of drugs with identical active ingredients
as both over the counter and prescription, I believe that the FDA should proceed with rulemaking to
codify its interpretation of section 503 (b), that there is significant confusion in its current state, and that
rulemaking would help dispel the confusion that is caused by the current rule. I also believe that the FDA
would be able to legally enforce limitations on certain subpopulations and that those limitations could be
practically enforced. Finally I believe that it would be legal to sell the products in the same packaging but
that there would be some circumstances where selling identical items would be inappropriate.
<2: 3.8.5>Codification of the FDA?s interpretation of section 503 (b) would be greatly beneficial. The
current wording of the rule is very broad and allows for very few exceptions. It seems to paint all drugs
with the same brush when each drug should be looked at separately. The very fact that there is the
question of a need for rulemaking illustrates the confusion on how the current rule should be interpreted
and applied. Questions could be raised about what qualifies as a difference. Do they have to apply to the
drug itself? Or can the circumstances of the some consumers count as a difference? There could also be
widely varying interpretations of what is safe and for whom it applies. The current set of rules seems to
group all drugs together and tries to separate over the counter from prescription with the same standards
for every drug it looks at. But when it gets down to individual drugs, the method of dividing into
prescription and over the counter may be totally inadequate. The FDA needs to address these questions in
their rulemaking. They need to provide for a clearer way to separate drugs into prescription and over the
counter. They also need to allow for exceptions when it comes to individual drugs. A large sweeping set
of rules that use the same standards to separate prescription and over the counter is bound to break down
along the way, as well as roll over some cases while letting other fall through the cracks. Codification of
the FDA?s interpretation of section 503 (b) would help to ensure that every drug gets looked at with the
standards it needs to and would allow exceptions based on the unique circumstances of individual drugs.
<3: 6.1, 6.3.5, 7.1> If the FDA during the process of rulemaking was to place restrictions on certain
subpopulations in regards to this rule, not only could it be legal but also vital to the rule affecting
significant change. I will assume that the main subpopulation targeted by the restrictions would be those
below a certain age. In this case, legally enforcing the rule will not only be legal, it will be practical as
well. There are currently age restrictions of all kinds that spread across a broad range of products. These
restrictions are enforced every day in a legal and practical manner. Putting similar restrictions on the over
the counter sell to a subpopulation below a certain age should not produce many legal or practical
problems and should also affect many of the same results that current restrictions do. Legal and practical
problems aside, putting restrictions on a certain age subpopulation would produce some highly desirable
effects. First off it would prevent irresponsible youths from acquiring drugs that they are either too young
to fully grasp the implications of or that support behaviors that are not desirable. In putting an age
restriction on over the counter sales of certain drugs and requiring a prescription for this subpopulation to
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 406 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 398
acquire the drug, it would allow a more responsible adult in on the decision. A doctor could more fully
explain the consequences and uses of a drug than an underage consumer could learn from reading the side
of a drug box. The effects of a drug alone are not the only concerns when dealing with the availability of
drugs to underage consumers. There are damaging behaviors that a lack of an age restriction would help
breed. In the case of the ?morning after pill,? the ability to get the drug over the counter would leave the
potentially detrimental side effects of the behavior that led up to the pill?s need unexplained. By going to
a doctor to get a prescription for the pill, there would be an opportunity for the potentially damaging
effects their behavior could have to be explained by a responsible and trained professional. At the very
least, an age restriction on certain drugs would allow for an older, and hopefully more responsible, person
in on the process.
<4: 8.1, 9.1.1>Finally, I do not see there being many legal problems arising from selling a product in the
same packaging simultaneously in over the counter and prescription venues. Seeing as how the main
reason for the separation of the two would be to allow someone more responsible in on an underage
consumer?s decision making, identical packaging would cause no great harm. But just because there are
many circumstances where identical packaging for both prescription and over the counter drugs is
appropriate, doesn?t mean that there are not circumstances where the same packaging wouldn?t be. In the
case of a consumer going to the doctor to get the drug, there should be great leeway for the doctor in
his/her decisions on things such as the number of doses that would require a different packaging. So while
identical packaging for over the counter and prescription drugs should be allowed, there are definitely
circumstances where it is in appropriate.
<5: 3.1, 3.8.3, 5.3.2>The FDA should most definitely codify its interpretation of section 503 (b) to resolve
confusion, it can and should place limits on certain subgroups, most notably those underage, and the FDA
should also allow the identical packaging of over the counter and prescription drugs but also keep in mind
that this is not always appropriate. The current state of the rules regarding prescription and over the
counter drugs is inadequate and the FDA should proceed in the rulemaking process.
COMMENT NUMBER - 2005N-0345-EMC383
2005N-0345-EMC383 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Babalola, Abimbola
2005N-0345-EMC383 - TEXT
From: no-reply@erulemaking.net
Sent: Monday, October 31, 2005 6:35 AM
To: Dockets, FDA
Subject: Public Submission
Please Do Not Reply This Email.
Public Comments on Drug Approvals: Circumstances Under Which an Active Ingredient May Be
Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug
Product:========
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 407 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 399
Title: Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously
Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product FR Document
Number: 05-17390 Legacy Document ID:
RIN:
Publish Date: 09/01/2005 00:00:00
Submitter Info:
First Name: Abimbola
Last Name: Babalola
Category: Consumer Group - B0001
Organization Name: Georgia State University
Comment Info: =================
General Comment:FDA?s Advance Notice of Proposed Rulemaking
By: Abimbola Babalola (GA State Undergrad Student)
<1: 3.1, 3.8.1>In our ever-changing society, it is extremely important that the executive branch of the
U.S. federal government fulfills its duties of faithfully executing laws that will benefit the lives of the
people of our nation. By employing the law, U.S. federal agencies such as the Food and Drug
Administration (FDA) officially announce vital rules on a daily basis to more thoroughly describe how
U.S. statutes will be applied to specific circumstances. But, these rules are often politically controversial,
requiring agencies to explain the reasons for their rules through the benefit of written public participation.
Such is the present case with the FDA, as this agency is seeking public comments in response to their
Advance Notice of Proposed Rulemaking (ANPRM) (Docket No. 2005N-0345) in dealing with the issue
of what types of drugs may be sold simultaneously both by prescription and over-the-counter products. If
the FDA initiates a plain-language rulemaking without using complicated and confusing speech in any
proposed rule, and for this issue, then drugs that are marketed in both prescription and over-the-counter
(OTC) drug products will provide easy access to consumers, will decrease the number of unintended
pregnancies in women in the case of the Plan B pill, and will be more affordable to consumers nation-
wide.
<2: 1.2.1>In order to have a better understanding as to why any drug should be simultaneously sold by
prescription and over-the-counter products, we must explore the FDA?s current issue of a particular Plan
B pill, an emergency contraceptive that prevents pregnancies in women. According to an FDA statement
released by FDA Commissioner Lester M. Crawford, the Plan B pill is currently available to all women
only as a prescription drug, but FDA officials have recently begun debating whether or not to allow this
drug to be marketed OTC to women who are 17 years of age and older, and remain prescription-only for
those under the age of 17. By taking a pro stance on this issue, the FDA would ultimately create easy
access of this, or any other drug, to consumers in at least a couple of ways. Useful and essential
information about the drug will not only be known to women older than 17 who use the prescription, but
women under 17 can read the drug labels on the OTC drug and educate themselves about what to expect
while using the drug, such as what dosage is proper for their age group and what type of side effects, if
any, are common. Also, easy accessibility of a drug, for example if the Plan B pill were to be sold both
by prescription and OTC at the same time, would be especially beneficial to women under the age of 17 if
an unfortunate case of rape were to occur to a particular individual. If a young woman under the age of
17 preferred to carefully prevent a pregnancy after being raped then she can easily purchase an OTC
bottle of Plan B pills at her will. In the American culture today, it is practically inevitable that many teens
will have premarital sex sometimes with or even without protection, therefore, greatly increasing their
risk of producing unintended pregnancies. According to an ABC News online article, Susan Wood,
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 408 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 400
director of FDA?s Office of Women?s Health, claimed that complete access to the Plan B pill would
significantly reduce unintended pregnancies and abortions. Basically, if the FDA proposes a rule
allowing particularly the Plan B pill to be sold as a prescription as well as an OTC drug, then many
unwanted and/or unintended pregnancies that can lead to abortions can be prevented. Susan Wood also
supplies evidence for these circumstances by noting that the morning-after pill is a high dose of regular
birth control that can lower the risk of pregnancy by up to 89 percent if it is taken within 72 hours of
unprotected sex. <3: 3.8.3>Another great reason why the FDA should propose a rule to allow
drugs to be sold simultaneously both as prescription and OTC drug products is because the drugs could be
more affordable to consumers. This can be the case in low-income families, or single-parent households
that probably might not have insurance to cover certain drug costs along with paying for doctor visits.
For example, if a single mother who is a diabetic needs to buy weekly supplies of insulin prescribed by
her doctor and she has no insurance to pay for the drug costs, while also paying for other living expenses,
then she can buy cheaper OTC pharmaceutical supplies versus the more expensive prescription. Taking
into account some of the beneficial reasons of why certain drugs should be simultaneously marketed as
both prescription and OTC drug products, the FDA should initiate a plain-language rulemaking to codify
its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act which provides the
Federal standard used to classify drugs as prescription or OTC, and it describes when and how to switch a
drug from prescription to OTC status. An FDA rulemaking would grant feasible accessibility of
medications to consumers by educating them about a certain drug and would allow them to care for
themselves given special circumstances. <4: 1.2.1>If the Plan B pill becomes available to
women under the age of 17, eventually the number of teen pregnancies and abortions nation-wide will
significantly decrease. <5: 3.8.3> In conclusion, a prescription and OTC drug product
marketed together would be cost efficient because a consumer can purchase a pharmaceutical OTC drug
even if his or her drug costs are not covered by insurance.
COMMENT NUMBER - 2005N-0345-EMC397
2005N-0345-EMC397 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: Vu, Tram
2005N-0345-EMC397 - TEXT
From: no-reply@erulemaking.net
Sent: Monday, October 31, 2005 9:54 AM
To: Dockets, FDA
Subject: Public Submission
Please Do Not Reply This Email.
Public Comments on Drug Approvals: Circumstances Under Which an Active Ingredient May Be
Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product:
Title: Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously
Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product FR Document
Number: 05-17390 Legacy Document ID:
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 409 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 401
RIN:
Publish Date: 09/01/2005 00:00:00
Submitter Info:
First Name: Tram
Last Name: Vu
Category: Consumer Group - B0001
Organization Name:
Comment Info:
General Comment:See Attachment.
ATTACHMENT:
Tram M. Vu
10540 Stonefield Landing
Duluth, GA 30097
Agency: Food and Drug Administration
Docket No. 2005N-0345
<1: 3.1, 3.8.3>In order to codify its interpretation of section 503(b) of the Federal Food, Drug, and
Cosmetic Act regarding when an active ingredient can be simultaneously marketed in both a prescription
drug product and an over the counter (OTC) drug product, the Food and Drug Administration should
initiate a rulemaking. Codifying section 503(b) set specific standards that pharmaceutical companies can
conform to so that there is no ambiguity in the ways drug companies can supply an active ingredient in
both markets. Also made clear would be the conditions under which a drug is to be administered and sold.
Established criterion and explanation protects consumers as well as eliminates carelessness of
pharmaceutical companies on their pursuit to drop new drugs into the market.
For instance, if a new drug were put on the market with active ingredient 'n,' the drug companies would
have to comply to more explicit standards and regulations enforced by the FDA in order to market the
drug as a prescription and/or OTC product. Further, codified interpretations of section 503(b) would
ensure standardized distribution under law. Providing concrete interpretation eliminates loopholes in
which the drug companies may use to their commercial advantage.
<2: 4.1, 4.3.3>The Federal Food, Drug, and Cosmetic Act's current language in section 503(b) is vague.
Consequently, confusion regarding the FDA's interpretation is significant. <3: 5.1, 5.3.1,
5.3.2>Codifying the FDA's interpretation of section 503(b) makes the language more explicit and makes
the federal administration more accountable to laws that were meant to protect consumers-as it is their
function to serve the public health and not to submit to the lobbying tactics of profit-seeking
pharmaceutical companies. In addition, clarification of the language protects consumers through means
of education-providing legitimate and obtainable information. Any ambiguity on federal standards with
regards to drugs should be accessible and in common language.
<4: 6.6.3, 7.4.5>Another issue raised in this advance notice of proposed rulemaking is whether or not the
FDA would be able to enforce a limitation, as a matter of law, on the sale of OTC products to a particular
subpopulation. Just as alcohol and tobacco are sold under the supervision of licensed sellers who confirm
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 410 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 402
identification, the prohibition of sale of any other OTC product to a subpopulation could be similarly
enforced. If a seller were to violate restrictions on the sale of certain OTC products which require careful
administration under law, it should be subject to penalty.
<5: 7.4.6>The sale of an OTC product to a particular subpopulation could be enforced as a practical
matter so long as proper implementation on the sale of such items is enacted. That is, sellers (and buyers)
are well-informed of the lawful implications intended for transactions involving the specific products.
What ever requirements may be established for the sale of a particular OTC product could be confirmed
with adequate and proper identification by a licensed seller.
<6: 8.2, 8.6.4, 9.1.1>Assuming it is legal to market the same active ingredient in a prescription and OTC
product, the different products should be sold in separate packages. The indications, side effects,
directions for use, strength of dosage, age restrictions, and other implications for the drug may not be
completely identical to its counter-part. Such differences in the drugs should be clarified through the
packaging for the benefit of the consumer. Separate packaging, along with restrictions on dispersal of the
prescription product, makes aware the distinction in the two products.
I hope not to undermine the FDA's concern for the general good of public health and the complexity of its
rulemaking process. I trust that the administration will act in the interest of its people by initiating a
rulemaking to make clear its interpretations of pre-established law. Establishing firm explanations of law
legitimizes the legislative body as a whole.
COMMENT NUMBER - 2005N-0345-EMC446
2005N-0345-EMC446 - STRUCTURED DATA ELEMENTS
Initiative Name: Simultaneous Marketing of Rx and OTC Products
Commenter Organization Name: American Civil Liberties Union
2005N-0345-EMC446 - TEXT
From: Leaderman, Elizabeth [eleaderman@dcaclu.org]
Sent: Tuesday, November 01, 2005 4:54 PM
To: Dockets, FDA
Subject: Comment: 2005N-0345
<>
Elizabeth Leaderman
Assistant to the Associate Director/Chief Legislative Counsel ACLU Washington National Office 915
15th Street NW Washington, DC 20005 eleaderman@dcaclu.org 202-675-2323
November 1, 2005
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 411 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 403
Re: Advance Notice for Proposed Rulemaking, Docket Number 2005N-0345 Regarding Barr
Laboratories' "Plan B" Petition
Dear Acting Commissioner von Eschenbach:
<1: 1.2.1>In response to the Advance Notice for Proposed Rulemaking, docket number 2005N-0345, the
ACLU urges the Food and Drug Administration ("FDA") to suspend the proposed rulemaking process
immediately and to approve without further delay Barr Laboratories' application to market Plan B, a form
of emergency contraception, without a prescription.
<2: 3.2>A rulemaking proceeding is neither necessary nor legally required to approve Barr's petition for
over-the-counter status for Plan B. <3: 1.2.1, 2.1>Increased access to Plan B would help prevent
unintended pregnancies, reduce abortions, and promote women's reproductive health and rights. The
FDA's continued delay in reaching a decision on this application permits politics to trump science and
amounts to a failure to meet the agency's obligation to promote and protect women's health. Moreover,
the agency's proposal for a two-tiered system of availability for Plan B would undermine the privacy
rights of women of all ages who seek access to this critical drug. The ACLU urges the FDA to abandon
this two-tiered approach and to permit women of all ages to purchase Plan B without a prescription.
Background
<4: 1.2.1>Plan B was approved by the FDA in 1999 for use as a contraceptive. According to the
approved labeling, Plan B decreases the risk of unintended pregnancy resulting from contraceptive failure
or unprotected intercourse by 89%. [Footnote 1: FDA, Center for Drug Research and Evaluation,
Medical Review, NDA 21045 (Plan B), available at http://www.fda.gov/cder/foi/nda/99/21-
045_Plan%20B_medr.pdf.] In April 2003, Barr Laboratories, Plan B's manufacturer, filed an application
with the FDA to make Plan B available over the counter.
In December 2003, two FDA advisory committees composed of medical experts voted overwhelmingly
(23-4) in favor of granting Barr's petition. In reaching this conclusion, the advisory committees
considered extensive scientific and social science evidence indicating that the drug is safe and effective
and that over-the-counter access to it would serve the public health. Indeed, the FDA panel unanimously
agreed both that Plan B was safe for use in a non-prescription setting and that there was no evidence that
over-the-counter availability leads sexually active individuals to substitute emergency contraception for
regular use of other contraceptive methods. See Advisory Committee in Joint Session with the Advisory
Committee for Reproductive Health Drugs 354-64 (Dec. 16, 2003). [Footnote 2: Available at
www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.pdf. ] FDA staff in the Center for Drug Evaluation
and Research also recommended that Plan B be approved for over-the-counter use. See Gardiner Harris,
Morning-After-Pill Ruling Defies Norm, New York Times, May 8, 2004, at A13.
Despite these views, in May 2004, the FDA rejected Barr's application, asserting that there was
insufficient evidence that Plan B could be used safely without a prescription by women under sixteen.
Based on the concerns expressed in the agency's non-approvable letter, Barr submitted a supplemental
application proposing a two-tiered structure under which Plan B would be made available over-the-
counter to women sixteen years of age or older, but only with a prescription to those under sixteen. The
agency failed to act on this revised application for more than a year. On August 26, 2005, the FDA
concluded, without warning, that Plan B should only be available over-the-counter to women seventeen
and older. The agency also announced that it would not act on Barr's petition and instead would initiate a
60-day public comment and rulemaking process with no timetable for making a decision.
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 412 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 404
No Rulemaking Proceeding Is Required to Approve Barr's Petition.
<5: 3.5.2>A rulemaking proceeding is neither necessary nor legally required for the FDA to approve
Barr's petition for over-the-counter status for Plan B. Although the FDA may change a drug's status from
prescription to over-the-counter via a rulemaking process, as stated in the Advanced Notice of Proposed
Rulemaking here, it may also change a drug's status by means of an agency order, in this case by
approving a Supplemental New Drug Application by authority granted under the Food, Drug, and
Cosmetic Act. [Footnote 3: See SEC v. Chenery, 332 U.S. 194, 202-203 (1947) (an administrative
agency has the authority to use either rulemaking or other authority granted it by Congress to make
decisions).] There is no compelling reason to require a rulemaking proceeding to evaluate Barr's
petition.
<6: 1.2.1>The FDA already possesses sufficient information to conclude that Plan B is safe for use
without a prescription. Plan B meets the FDA's criteria for determining that a drug is appropriate for
over-the-counter use. It treats a condition that patients can diagnose themselves; it is safe and effective
when used without direct prescriber supervision; and the drug's label adequately explains potential
adverse effects and conditions of use. Plan B is easy to use, is not addictive, and has no known health
hazards when self-administered. The drug has virtually no contraindications and few side effects. There
is simply no compelling medical rationale for restricting Plan B to prescription-only use. The rulemaking
process should therefore be suspended.
The FDA's Refusal to Approve Barr's Petition Cannot Be Justified By Medical Science.
<7: 1.2.1>The FDA's continued refusal to act on Barr's petition flies in the face of recommendations by
two FDA Advisory Committees, FDA officials, and major medical groups. Two of the FDA's own
advisory committees voted overwhelmingly to allow Plan B to be made available without a prescription.
In concluding that emergency contraceptives are safe and effective, the FDA advisory panel considered a
study showing that easy access to such contraceptives does not cause adolescents to have more
unprotected sex or to stop using contraception.
The advisory committee's recommendation that Plan B be approved for non-prescription use was
supported by the staff of the FDA. Indeed, memoranda from the FDA staff show the extent of
disagreement with the agency's final decision to delay approval indefinitely: One senior FDA employee
described the reasoning used to justify denying immediate approval for Plan B as "speculative and
unbalanced." Marc Kaufman, Staff Scientists Reject FDA's Plan B Reasoning, Washington Post, June 18,
2004, at A02. Dr. Susan Wood, the former director of FDA's Office of Women's Health who resigned in
protest over the agency's refusal to act on the petition, explained, "[S]cientific and clinical evidence, fully
evaluated and recommended for approval by the professional staff [at the FDA], has been overruled."
F.D.A. Aide Quits in Protest of Morning-After Pill Decision, Associated Press, August 31, 2005.
Moreover, major medical groups, including the American College of Obstetricians and Gynecologists, the
American Medical Association, and the American Public Health Association, also supported making Plan
B more readily accessible.
By refusing to act on Barr's application, the FDA ignored the scientific evidence and has turned what
should be a science-based decision on a drug approval into a political game.
Over-the-Counter Availability Ensures Access to Emergency Contraception for the Many Women Who
Need It.
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Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 405
<8: 1.2.1>Nearly half of all pregnancies in the United States are unintended. See Alan Guttmacher
Institute, Questions About Pregnancy, Contraception and Abortion (2004). [Footnote 4: Available at
http://www.agi-usa.org/in-the-know/pregnancy.html.] For the women who face a potential unintended
pregnancy, widespread and timely access to emergency contraception is critical.
Emergency contraception must be taken within 72 to 120 hours after unprotected intercourse, but experts
agree that it is more effective the sooner it is taken. See Charlotte Ellertson et al., Extending the Time
Limit for Starting the Yuzpe Regimen of Emergency Contraception to 120 Hours, 101 Obstet. Gynecol.
1168, 1168 (2003). This narrow window makes ready access to emergency contraception critical. The
current requirement that emergency contraception only be dispensed with a doctor's prescription acts as
significant barrier to obtaining this safe and effective method of birth control. A woman who has just
experienced unprotected sex, contraceptive failure, or sexual assault, must find an available physician
who can and will fill a Plan B prescription; obtain the prescription; find a pharmacy and pharmacist that
will dispense the drug; fill the prescription; and take the medication -- all "while the time window for
efficacy is closing." Alastair Wood, et al., A Sad Day for Science at the FDA, 535 N. Engl. J. Med. 1197
(2005). For women who cannot afford a doctor's appointment, whose doctor's office is closed during the
critical period, or who cannot obtain an appointment within the short window, the prescription
requirement serves as a major impediment to obtaining the drug within the necessary time frame.
Denied access to emergency contraception, some women will face a choice of either continuing an
unwanted pregnancy or having an abortion. See Rachel K. Jones et al., Contraceptive Use Among U.S.
Women Having Abortions in 2000-2001, 34 Persp. on Sex & Reprod. Health 294, 300 (2002) (estimating
51,000 abortions were prevented in 2000 alone because of emergency contraceptive use). Emergency
contraception prevents pregnancy, but does not disrupt an existing pregnancy. Moreover, emergency
contraception is safe: to date, millions of women have used emergency contraception with no serious side
effects or contraindications that would endanger their health. See World Health Organization, Emergency
Contraception: A Guide for Service Delivery (1998).
Age-Based Restrictions Are Unnecessary, Will Infringe Women's Privacy Rights, and Will Impede
Women of All Ages from Obtaining Plan B.
<9: 1.2.1>There is no scientific evidence that women under the age of seventeen are unable to use Plan B
safely without a prescription. Data presented to the FDA in conjunction with Barr's original application
demonstrated that Plan B is safe for young women and that more open access to Plan B does not increase
risk-taking behavior, such as having unprotected sex, among teens. See Melanie Gold, Testimony at the
Meeting of the FDA Nonprescription Drugs Advisory Committee in Joint Session with the Advisory
Committee for Reproductive Health Drugs 155-57 (Dec. 16, 2003). [Footnote 5: Available at
www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.pdf. ] Indeed, the FDA has not identified any data
indicating that Plan B poses a health threat to younger women. See Alastair Wood, et al., A Sad Day for
Science at the FDA, 535 N. Engl. J. Med. 1197, 1198 (2005).
<10: 1.2.1>And, significantly, imposing age-based restrictions on Plan B will breach the privacy rights of
all women who seek access to this critical drug. A two-tiered, age-based structure will require
pharmacies that sell Plan B over-the-counter to impose mandatory proof of age requirements on all
women who purchase the drug. Such a requirement, which is not placed on other over-the-counter drugs,
constitutes an unwarranted invasion of a woman's privacy. The prospect of being forced to produce
public identification while purchasing a drug as personal and intimate as emergency contraception is
likely to deter women of all ages from purchasing the drug. Given Plan B's demonstrated safety record,
such an invasion serves no legitimate purpose, and indeed may only humiliate a woman who has just
experienced contraceptive failure, unprotected sex, or sexual assault.
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 414 of 415
Final Bracketed Comment Letter Report on Simultaneous Marketing ANPRM – Page 406
Improved Access to Emergency Contraception Is Particularly Critical for Sexual Assault Survivors.
<11: 1.2.1>Over-the-counter access to emergency contraception is especially important for sexual assault
survivors. Every year, approximately 25,000 pregnancies occur because of sexual assault. See Felicia
Stewart et al., Prevention of Pregnancy Resulting from Rape: A Neglected Preventive Health Measure,
19 Am. J. Preventive Med. 228, 228 (2000). Emergency contraception could prevent approximately
22,000 of these pregnancies. Id. at 229. Yet in many areas, more than half of hospital emergency rooms
fail to provide emergency contraception to sexual assault patients routinely. See ACLU Reproductive
Freedom Project Briefing Paper, Preventing Pregnancy after Rape: Emergency Care Facilities Put
Women at Risk (2004). [Footnote 6: Available at
http://www.aclu.org/ReproductiveRights/ReproductiveRights.cfm?ID=17212&c=30. ] The prescription
requirement serves as a major barrier to access to emergency contraception for sexual assault survivors in
these areas. If a woman is denied access to emergency contraception in the emergency room to which she
is initially brought, she must then somehow track down another doctor, answer more personal and painful
questions, and find a pharmacy to fill her prescription, all within 72 to 120 hours of the assault. Ready
availability of emergency contraception without a doctor's prescription would mean that at least one
injury from the assault, the possibility of pregnancy, could be quickly and safely alleviated.
Conclusion
<12: 2.1>Approving over-the-counter access to Plan B will promote public health, prevent unintended
pregnancies, and reduce abortions. Age-based restrictions, which are not medically warranted, will chill
the ability of women of all ages to access Plan B. Given the strong support for the petition expressed by
the FDA's independent committee of experts, FDA staff, and major medical groups, the ACLU urges you
to suspend the rulemaking process and to act without further delay to approve over-the-counter status for
Plan B emergency contraception.
Sincerely,
Caroline FredricksonDirector
Washington Legislative Office
Greg Nojeim
Associate Director
Washington Legislative Office
Case 1:07-cv-00668-JDB Document 45-4 Filed 03/18/2008 Page 415 of 415
Exhibit 2
Case 1:07-cv-00668-JDB Document 45-5 Filed 03/18/2008 Page 1 of 4
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
ASSOCIATION OF AMERICAN PHYSICIANS
& SURGEONS, INC., et al.,
Plaintiffs,
v.
FOOD & DRUG ADMINISTRATION, et al.,
Defendants,
and
DURAMED PHARMACEUTICALS, INC.,
Defendant-Intervenor
)
)
)
)
)
)
)
)
)
)
)
)
Civil Action No. 07-0668-JDB
DECLATIONATION LAWRENCE J. JOSEPH
I, Lawrence J. Joseph, hereby declare and state as follows:
1. I am over the age of 18, and I reside in McLean, Virginia.
2. I am an attorney representing plaintiffs Association of American Physicians &
Surgeons, Inc., Concerned Women for America, Family Research Council, and Safe Drugs for
Women (collectively “Plaintiffs”) in the above-captioned action.
3. On March 18, 2008, I downloaded Exhibit 1 to Plaintiff’s post-dismissal motion
under Rules 15, 52(c), 59(e) and 60(b) in the above-captioned action from
http://www.fda.gov/oc/planb/Bracketed%20Letters%20Report.pdf on Defendant Food & Drug
Administration’s website. It remained in my sole possession and control at all times prior to my
filing it.
4. On Monday, February 18, my five-year-old son developed a fever, which spiked
to over 104 degrees for much of that night. I spent the night up with him to try to lower his fever
Case 1:07-cv-00668-JDB Document 45-5 Filed 03/18/2008 Page 2 of 4
2
with a washcloth dipped in icewater and taking a shower with him. I took him to the doctor the
next day, and he was diagnosed as having both the flu and strep throat, for which his physician
prescribed tamiflu (5 days) and amoxicillin (10 days). I also spent time with him that day and
again stayed up with him that night, when his fever again spiked over 104 degrees. By Thursday,
I had developed what I considered merely a bad cold, which worsened significantly on Friday
night.
5. I went to the emergency room on Saturday morning and was diagnosed as having
the flu (and probably strep throat – the doctor told me it was not worth checking because I
probably had it if my son did) and prescribed the same two drugs as my son. I remained very ill
through Monday, February 25.
6. Pursuant to Local Rule 7(m), I began the process of conferring with opposing
counsel on Plaintiffs’ non-dispositive motion for judicial notice as signaled at oral argument. The
email attached to the foregoing motion as Exhibit 3 is the exchange between counsel. I did not
receive a reply (other than the inquiry from Ms. Lyons on February 27, 2008) before the Court
entered it decision and order on March 4, 2008.
7. On January 23, 2008, my client Concerned Women for America forwarded me an
email by a “blogger” who indicated that she had just transcribed a speech by U.S. Senator
Hillary R. Clinton to Planned Parenthood, which included a link to a video of the speech
(http://www.imoneinamillion.com/ (last visited Mar. 18, 2008)). Although the speech took place
on July 17, 2007, neither I nor (I have been told) my clients were aware of the speech’s contents.
In the speech, Senator Clinton indicates that she conditioned the lifting of her hold on Dr. von
Eschenbach’s on approving Plan B for over-the-counter distribution.
8. The relevant discussion occurs at approximately minute 16:30 of the video, where
Case 1:07-cv-00668-JDB Document 45-5 Filed 03/18/2008 Page 3 of 4
3
Senator Clinton states “Now in the end, Senator Patty Murray and I had to stop them not once
but twice. We had to put a hold on one nomination and then they told us that they would make a
decision, so we said alright we will lift our hold. And then they came out, as some of you will
recall, and said, ‘Our decision is to decide we’re not deciding.’ So then when they nominated
another FDA commissioner, Patty and I said, ‘Fool me once shame on you, fool me twice, shame
on us. We’re not letting anybody get confirmed until you promise to approve over-the-counter
Plan B.’” I have recorded the relevant portions of the speech and can submit it via compact disc
if the video moves from its current location.
9. In its Motion to Dismiss, at 7 n.8, Duramed located a copy of the comments filed
by Concerned Women for America and Family Research Council, located at
http://www.cwfa.org/images/content/planbfiling_CWA_%20FRC_e_%20al_11-01-2005.pdf
(last visited Mar. 18, 2008).
10. I have personal knowledge of the foregoing and am competent both to testify to it
at trial and/or to establish it by the submittal of documentary evidence at trial.
I declare under penalty of perjury that the foregoing is true and correct. Executed on this 18th day
of March 2008.
/s/ Lawrence J. Joseph
Lawrence J. Joseph
Case 1:07-cv-00668-JDB Document 45-5 Filed 03/18/2008 Page 4 of 4
Exhibit 3
Case 1:07-cv-00668-JDB Document 45-6 Filed 03/18/2008 Page 1 of 3
1
Larry Joseph
From: Larry Joseph [ljoseph@larryjoseph.com]
Sent: Saturday, March 01, 2008 11:21 AM
To: 'Lyons, Jane (USADC)'; 'Ana C. Reyes'
Subject: RE: AAPS v. FDA, No. 07-0668-JDB (D.D.C.): Motion for Judicial Notice
Dear Jane and Ana,
One other thing for which plaintiffs will seek judicial notice: the government argued that the judicial‐review provisions of
the National Wrestling Coaches Association (NWCA) decision is dicta: “[b]ecause petitioners lack standing…, [judicial
review] is not properly presented here.” Brief for the Respondent in Opp’n, at 11, NWCA v. Dep’t of Educ., No. 04‐922
(U.S.), 2005 WL 997132.
Best regards,
Larry
From: Larry Joseph [mailto:ljoseph@larryjoseph.com]
Sent: Thursday, February 28, 2008 4:08 PM
To: 'Lyons, Jane (USADC)'; 'Ana C. Reyes'
Subject: RE: AAPS v. FDA, No. 07-0668-JDB (D.D.C.): Motion for Judicial Notice
Dear Jane and Ana,
Here are the facts we want the Court to take notice of:
First, that the issues behind Counts I‐VI came up in the ANPRM comments. To establish that, we will attach or excerpt
the following: (1) AAPS comments; and (2) CWA et al. comments. We will use the FDA contractor’s version of the
comments to show that FDA received the comments in question.
Second, that FDA and Dr. von Eschenbach considered the ANPRM comments in connection with the decision to proceed
on the SNDA. To establish that, we will attach or excerpt the following: (1) FDA’s letter dated July 31, 2006; and (2)
testimony and/or written responses to questions from Dr. von Eschenbach’s confirmation hearing, as well as possibly a
video file of the same.
Third, that FDA acted pursuant to 21 CFR 310.200(b). To establish that, we will attach or excerpt the August 24, 2006,
Galson memo.
Fourth, that Congress amended PREA in July 2007 in Sections 21 USC 355c(g)(2), (h)(1)‐(2) and in Section 402(b) of the
2007 amendments. To establish that, we will provide the text of the foregoing sections.
Fifth, that Senator Clinton has stated on the campaign trail that, during her hold on Dr. von Eschenbach’s confirmation,
she had said that she would not let anyone get confirmed until FDA promised to approve over‐the‐counter Plan B. To
establish that, we will provide a video file.
Please let me know if you will oppose the motion.
Best regards,
Larry
From: Lyons, Jane (USADC) [mailto:Jane.Lyons@usdoj.gov]
Sent: Wednesday, February 27, 2008 2:11 PM
To: Larry Joseph; Ana C. Reyes
Subject: RE: AAPS v. FDA, No. 07-0668-JDB (D.D.C.): Motion for Judicial Notice
Larry,
Case 1:07-cv-00668-JDB Document 45-6 Filed 03/18/2008 Page 2 of 3
2
Sorry to hear you have been under the weather. I think it would be appropriate for you to identify exactly what you
will be asking the Court to take judicial notice of so that we can respond specifically. And we will need to be afforded a
reasonable amount of time in which to consult with our clients, so please plan appropriately. I don’t mean to sound
insensitive, but illness on your part does not constitute an emergency on mine.
Jane
From: Larry Joseph [mailto:ljoseph@larryjoseph.com]
Sent: Wednesday, February 27, 2008 1:29 PM
To: Lyons, Jane (USADC); Ana C. Reyes
Subject: AAPS v. FDA, No. 07-0668-JDB (D.D.C.): Motion for Judicial Notice
Dear Jane and Ana,
FYI, later this afternoon, plaintiffs will file a notice of supplemental authority on the Bracco Diagnostics case already
cited by FDA.
I apologize about my delay on all fronts: I got pretty sick Friday night and stayed that way for several days. I’ve basically
now dug myself out of my flu‐induced delay and am turning to the motion for judicial notice of various
government/public documents (e.g., ANPRM comments, FDA‐Barr correspondence, testimony, speeches).
From what I understand of your clients’ position on exhaustion of administrative remedies, you could argue for the
irrelevancy of all of the documents from what plaintiffs would characterize as part of the administrative record.
Irrelevance presumably would defeat judicial notice under Fed. R. Evid. 402 (“[e]vidence which is not relevant is not
admissible”). Should I just say that you oppose the motion because the materials are not part of the SNDA record? What
sort of discussion would you like to have? If you want to talk, as opposed to email, are there good times?
Best,
Larry
Law Office of Lawrence J. Joseph
1250 Connecticut Avenue, NW, Suite 200
Washington, DC 20036
Tel: 202-747-1790
Fax: 202-318-2254
Email: ljoseph@larryjoseph.com
Case 1:07-cv-00668-JDB Document 45-6 Filed 03/18/2008 Page 3 of 3
