Similarly, a manufacturer’s statements about unapproved uses do not render the drug misbranded for lack of adequate directions for use unless they establish, by themselves or together with other evidence, that the unapproved use is an intended one. See 21 U.S.C. § 352(f)(1). If the contents of the manufacturer’s speech and the surrounding circumstances do not show that the manufacturer intends the unapproved use, then the manufacturer is free to engage in the speech without exposing itself to liability under the Act.

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.

(See, e.g., Undisputed Fact No. 51.) Had GSK retained or added back a warning regarding adult suicidality for Paxil despite FDA’s instruction to the contrary, Paxil’s labeling would have been false and misleading (21 U.S.C. § 352(a)), lacking adequate direction for use (§ 352(f)(1)), thereby causing Paxil to be deemed misbranded and its distribution a “prohibited act” (§ 331(a), (d), (k)). This exposes the company to potential civil and criminal enforcement (§§ 332-334).

Whether the FDCA refers to such packaging by the term of art “non-functional slack-fill” or simply as misleading packaging in its regulations has no bearing on the merit of Plaintiffs’ claims. 15 Under 21 U.S.C. § 352(i)(1), “[a] drug or device shall be deemed to be misbranded. . . “[i]f it is a drug and its container is so made, formed, or filled as to be misleading. . . .”

Plaintiff asserts that Defendants violated certain federal regulations, 21 U.S.C. § 352. (See Rec. Doc. 35 ¶ 96.) But, “these provisions [21 U.S.C. §§ 321, 352] do not create a cause of 4 To the extent that Plaintiff pleads claims of fraudulent misrepresentations, these claims are also precluded under the exclusivity of the LPLA.

As noted above, the FDCA deems a drug “misbranded” if the drug’s labeling lacks “adequate directions for use.” 21 U.S.C. § 352(f)(1).2 Under FDA regulations, for a prescription drug to avoid being misbranded, its labeling must have sufficient directions for “the purposes for which [the drug] is intended, including all purposes for which [the drug] is advertised or represented.” 21 C.F.R. § 201.

...............................................14 21 U.S.C. § 301................................................................................................................................5 21 U.S.C. §331(a) ............................................................................................................................7 21 U.S.C. §331 (b) ...........................................................................................................................7 21 U.S.C. §352(a) ............................................................................................................................7 Case 2:09-cv-03010-MCE-EFB Document 123 Filed 06/04/14 Page 7 of 28 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 v OPPOSITION TO MOTIONS TO DISMISS 21 U.S.C. §352(f) .............................................................................................................................7 21 U.S.C. §352(n) ............................................................................................................................7 31 U.S.C. § 3729(a)(1)(A) .............................................................................................................13 31 U.S.C. § 3729 (a)(1)(A)-(C)........................................................................................................8 31 U.S.C. § 3729(b) .........................................................................................................................8 42 U.S.C. §1320a-7b(b)(1) ............................................................................................................13 42 U.S.C. §1320a-7b(b)(2)(B) .......................................................................................................13 42 U.S.C. § 1320a-7b(b), et seq. ......................................................................................................1 42 U.S.C. §1395ww(d) ...................

Defendants created the advertising claims, and can be held to them. See Bates, 544 U.S. at 439, 444; 21 U.S.C. § 352(a); Resendes Decl., Ex. 4 at 24.

In its January 2006 Preamble to the Final Rule on prescription drug labeling, FDA discussed its position that state-law tort claims are preempted if they conflict with its regulation of prescription drug labeling: State laws conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law when they purport to compel a firm to include in labeling or advertising a statement that FDA has considered and found scientifically unsubstantiated. In such cases, including the statement in labeling or advertising would render the drug misbranded under the act (21 U.S.C. § 352 (a) and (f)). 71 Fed. Reg.

BIOVAIL HAS SATISFIED THE OTHER ELEMENTS FOR PRELIMINARY INJUNCTIVE RELIEF In approving ANDAs for generic versions of WELLBUTRIN XL® whose labels are false and misleading, FDA has violated the plain meaning of the FDCA. See 21 U.S.C. § 352(a). Biovail therefore possesses a “particularly strong” likelihood of success on the merits.