National Ethical Pharmaceutical Ass'n v. Weinberger

This is an action by National Ethical Pharmaceutical Association, a trade association, and Pharmaceutical Associates, Inc., one of its member companies, seeking judicial review pursuant to the Administrative Procedure Act (5 U. S.C. §§ 701-704), of the regulation by the Food and Drug Administration of certain drugs which were treated as “new drugs,” and for a declaratory judgment pursuant to the Declaratory Judgment Act (28 U.S.C. § 2201) that those drugs are not “new drugs.” Such a declaration would exempt those drugs from rigid premarketing standards regarding manufacture and purity and…