Citations
- 783 F. Supp. 2d 104
Full opinion text
MEMORANDUM OPINION
REGGIE B. WALTON, District Judge.
The plaintiff filed its Complaint in this case on July 8, 2010, alleging that certain actions taken by the United States Food and Drug Administration (the “FDA”) violated both the Administrative Procedure Act (“APA”), 5 U.S.C. § 702 (2006), and the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(a) (2006). This case is now before the Court on the parties’ cross-motions for summary judgment. See Plaintiff’s Motion for Summary Judgment (“Pl.’s Mot.”); Federal Defendants’ Motion for Summary Judgment (“Defs.’ Mot.”). Defendant-Intervenor Nycomed US, Inc. (“Nycomed”) opposes the plaintiffs motion for summary judgment and supports the federal defendants’ motion for summary judgment. See Def.-Int.’s Mem. at 1. For the reasons explained below, the plaintiffs motion for summary judgment is denied and the defendants’ motion for summary judgment is granted.
I. BACKGROUND
A. Statutory and Regulatory Framework
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 other words, the FDCA “requires all new prescription drugs to obtain FDA approval under a new drug application (‘NDA’) before they can enter the marketplace.” PL’s Mem. at 4. An NDA submitted by a drug manufacturer seeking FDA approval of a brand name drug, also known as a pioneer drug, must include, among other information, “full reports of investigations which have been made to show whether ... [the] drug is safe for use and whether [the] drug is effective in use.” 21 U.S.C. § 355(b)(1)(A). A drug manufacturer seeking FDA approval of a generic drug may, however, obtain such approval with an abbreviated new drug application (“ANDA”). Id. § 355