The Food, Drug, and Cosmetic Act ("FDCA"), ch. 675, 52 Stat. 1040 (codified as amended at 21 U.S.C. § 301 et seq.), provides the framework for federal regulation of prescription drugs in the United States. Under the FDCA, a manufacturer must seek approval from the United States Food and Drug Administration ("FDA") to market a new drug and, in doing so, must first file a New Drug Application ("NDA") and then prove the drug's safety and efficacy and propose accurate and adequate labeling. 21 U.S.C. § 355(b)(1), (d). As the Supreme Court has recognized, "[m]eeting those requirements involves costly and lengthy clinical testing." PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2574 (2011). In Re Fosamax (Alendronate Sodium), 751 F. 3d 150 (3rd Cir. 2014).
Congress has amended the FDCA several times, including in 1984 by passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act"), codified at 21 U.S.C. §§ 355, 360cc and 35 U.S.C. §§ 156, 271, 282. The Hatch-Waxman Act governs the production and sale of generic versions of previously approved brand-name drugs. In short, it allows the manufacturers of generic drugs to "gain FDA approval simply by showing equivalence to a . . . drug that has already been approved by the FDA." Mensing, 131 S. Ct. at 2574 (citing 21 U.S.C. § 355(j)(2)(A)). A manufacturer seeking approval of a generic drug will file an Abbreviated New Drug Application ("ANDA") demonstrating that the generic drug and the FDA-approved brand-name drug are bioequivalent; in addition to having the same active ingredients, the brand-name drug and the generic version must share the same route of administration, dosage form, dosage strength, and labeling. 21 U.S.C. § 355(j)(2)(A)(ii)-(v). The statutory aim is to "allow[] manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug." Mensing, 131 S. Ct. at 2574. [Footnotes omitted.] In Re Fosamax, ibid.
THIS CASEBOOK contains a selection of 30 U. S. Court of Appeals decisions that analyze and interpret provisions of the Hatch-Waxman Act. The selection of decisions spans from January 2010 to the date of publication.