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American Bioscience, Inc. v. Thompson

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Argued January 18, 2001

This appeal from the district court’s judgment denying a preliminary injunction against the Food and Drug Administration requires us to consider once again the Supreme Court’s opinion in Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402 (1971). Although the procedural background of the appeal is complex, our reasons for vacating and remanding are simple: the administrative record was never filed in court and we cannot tell on what basis the Food and Drug Administration took the agency action the plaintiff seeks to enjoin.

The statutory framework is as follows. A company wishing to market a drug must seek FDA approval usually by completing a “New Drug Application” (NDA) containing data from tests showing the drug’s safety and effectiveness. See Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060, 1063 (D.C. Cir. 1998). The Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act in 1984 made it easier for drug manufacturers to obtain approval of generic drugs. See Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified in scattered sections of 21, 35 & 42 U.S.C.). Under these amendments, a generic drug producer need not undertake the complicated and time-consuming testing process associated with an NDA and can instead file an “Abbreviated New Drug Application” (ANDA), relying on the NDA filed by the original manufacturer. See 21 U.S.C. � 355(j); Mova Pharmaceutical Corp., 140 F.3d at 1063.

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