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.

35. In addition, FDA regulations explicitly authorize the use of a citizen’s petition to seek a switch from prescription to OTC status: “A proposal to exempt a drug from the prescription- dispensing requirements of section 503(b)(1)(C) of the act may be initiated by . . . any interested person . . . fil[ing] a petition . . . pursuant to Part 10 of this chapter . . . .” 21 C.F.R. § 310.200(b). Once a citizen’s petition has been filed, the FDA is required by its regulations to either approve the petition, deny the petition, or “[p]rovide a tentative response, indicating why the agency has been unable to reach a decision on the petition, e.g., because of the existence of other agency priorities, or a need for additional information.”

Furthermore, FDA regulations explicitly provide that an OTC switch may be accomplished through a drug’s sponsor’s submission of a supplement to its NDA (i.e., an SNDA), requesting the L-only to non-L switch. 21 C.F.R. § 310.200(b). Case 1:07-cv-00668-JDB Document 12 Filed 06/29/2007 Page 42 of 46 -41- Plaintiffs ignore this latter option and instead appear to allege that section 353(b)(3), which provides that “[t]he Secretary may by regulation” remove the L-only designation for an approved drug “when such [prescription] requirements are not necessary for the protection of the public health,” is the exclusive authority for making an OTC switch.

See also Apotex, Inc. v. FDA, No. 06-5060, 2007 U.S. App. LEXIS 4270 at *5 (D.C. Cir. Feb. 23, 2007) (noting that FDA drug application approval letters represent “informal adjudications”); Am. Bioscience, Inc. v. Thompson, 243 F.3d 579, 582 (D.C. Cir. 2001) (FDA consideration of a drug application is an “informal adjudication”). Significantly, nothing in the language of 21 U.S.C. § 353(b)(3) forecloses FDA from approving an L-OTC switch in the context of drug application proceedings, and FDA regulations, 21 C.F.R. § 310.200(b), specifically provide for it.

It has been repeatedly shown that emergency contraception is safe and effective for self-administration and that its labeling clearly provides directions for safe use and warnings regarding unsafe use, side effects, and adverse reactions. See 21 C.F.R. § 310.200(b); § 330.10(a)(4); Tummino, 603 F. Supp. 2d at 525.

Nor do the regulations distinguish between SNDAs, Commissioner-initiated agency action, and citizen petitions. 21 C.F.R. § 310.200, titled “Prescription-exemption procedure,” states: “A proposal to exempt a drug from the prescription dispensing requirements of [the FDCA] may be initiated by the Commissioner or by any interested person. Any interested person may file a petition seeking such exemption, which petition may be pursuant to part 10 of Case 1:12-cv-00763-ERK-VVP Document 85 Filed 04/05/13 Page 58 of 59 PageID #: 2183 59 this chapter [citizen petitions], or in the form of a supplement to an approved new drug application.”

SAC ¶52 (“over-the-counter drugs are forbidden to bear a label containing this [prescription] caution Case 1:07-cv-00668-JDB Document 53 Filed 05/08/2008 Page 3 of 12 4 statement”) (quoting S. REP. NO. 82-946, at 10 (1951) and citing 21 C.F.R. §310.200(d)); accord 21 C.F.R. §310.200(d) (“The use of the prescription 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”). Because Senator Clinton’s ultimatum undercuts both this Court’s deference to the defendants’ unprecedented dual Rx-OTC approval and this Court’s sub silentio rejection of plaintiffs’ merits views, the speech meets FED.

-25- FDA regulations in their current form acknowledge these different switch mechanisms without any mention of the need to conduct rulemaking regarding an SNDA. 21 C.F.R. § 310.200(b). Plaintiffs, however, cite an earlier version of that regulation which appears to provide for rulemaking even when the request for a switch is made through a supplemental new drug application.

See 21 U.S.C. § 353(b)(3). Such a switch can be initiated by the Commissioner, 21 C.F.R. § 310.200(b), by any interested person who files a citizen petition, id § 10.25(a), or by the request of a drug sponsor, id § 310.

As amended, but dating back to 1954 in pertinent part, FDA’s implementing regulation provides that “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). Those two processes (§503(b)(3) rulemaking and OTC monograph) are the exclu- sive means to remove a new drug from §503(b)(1)’s prescription requirements when those re- quirements are unnecessary to protect public health.