Lannett Company, Inc. v. United States Food and Drug Administration

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA __________________________________________ ) LANNETT COMPANY, INC. and ) LANNETT HOLDINGS, INC., ) ) Plaintiffs, ) ) v. ) Civil Action No. 16-1350 (RBW) ) UNITED STATES FOOD AND DRUG ) ADMINISTRATION, et al., ) ) Defendants. ) __________________________________________) MEMORANDUM OPINION The plaintiffs, Lannett Company, Inc. and Lannett Holdings, Inc. (collectively, “Lannett”), bring this action against the defendants, the United States Food and Drug Administration (the “FDA”) and the United States, for judicial review of the FDA’s decision to rescind “the marketing approval for one of [their] generic drugs[, Temozolomide,] based on the agency’s argument that the approval was ‘mistakenly granted.’” Complaint (“Compl.”) at 2. Specifically, Lannett petitions this Court to “[s]et aside the FDA’s rescission of [its] [Abbreviated New Drug Application (“ANDA”)] approval” of Temozolomide, to “[d]eclare [the] FDA’s rescission of [its] ANDA approval unlawful,” and to “[e]njoin [the] FDA from revoking the ANDA approval for [its] Temozolomide Capsules in the future without a hearing, and without following the procedures established by 21 U.S.C. § 355(e) [(2012)].” Id. at 18. Currently before the Court are the Plaintiffs’ Motion for Summary Judgment (“Pls.’ Mot.”), ECF No. 16, the Defendants’ Cross-Motion for Summary Judgment and in Opposition to Plaintiffs’ Motion for Summary Judgment (“Defs.’ Summ. J. Mot.”), ECF No. 37, and the Defendants’ Motion to Strike Extra-Record Documents (“Defs.’ Mot.”). After careful consideration of the parties’ submissions and the administrative record (“A.R.”), 1 the Court concludes for the reasons set forth below that it must deny the plaintiffs’ motion for summary judgment, grant the defendants’ cross-motion for summary judgment, and deny as moot the defendants’ motion to strike. I. STATUTORY AND REGULATORY BACKGROUND The Food, Drug, and Cosmetic Act (the “FDCA”) provides that “[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to . . . this section is effective with respect to such drug.” 21 U.S.C. § 355(a). In order to obtain approval, a new drug application (a “NDA”) must include, among other things, “full reports of investigations which have been made to show whether or not [the] drug is safe for use and whether [the] drug is effective in use.” Id. § 355(b)(1)(A). Because this process is “costly and time[-]consuming,” Congress amended the FDCA in 1984 to “permit[] a manufacturer of a generic alternative to a pioneer drug to seek FDA approval by submitting an [ANDA],” Serono Labs., Inc. v. Shalala, 158 F.3d 1313, 1316 (D.C. Cir. 1998), which references and relies on the prior approval of the pioneer drug, Astellas Pharma US, Inc. v. FDA, 642 F. Supp. 2d 10, 13–14 (D.D.C. 2009). So, “[r]ather than requiring the [ANDA] applicant to make an independent showing that the proposed generic is itself safe and effective, the amended statute requires a showing that the proposed generic operates in the same manner as the pioneer drug on 1 In addition to the filings already identified, the Court considered the following submissions ...

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