Abbott Laboratories v. Gardner

Facts

Congress amended the Federal Food, Drug and Cosmetic Act in 1962 to require manufacturers of prescription drugs to print the “established name” (generic name) of the drug prominently and in type at least half as large as the type used for the “proprietary name” (brand name) on labels and other printed material. The purpose was to inform doctors and patients of drugs’ established names so that they could be purchased at lower prices. The Commissioner of Food and Drugs published proposed regulations (in addition to the Act) which required all drug labels and drug advertisements to put the established name next to the proprietary name every time the proprietary name appeared. A group of 37 drug manufacturers (the Petitioners) challenged the regulations on the grounds that the Commissioner exceeded his authority under the Act in issuing the regulations. The District Court granted injunctive and declaratory relief against the Commissioner. The Court of Appeals for the Third Circuit reversed, holding (1) that pre- enforcement review of the regulations was not permitted by the Act, and (2) that no relief was available under the Administrative Procedure Act because no actual case or controversy existed. The Supreme Court of the United States granted certiorari.