This section contains the nature of the case and procedural background.

The Food, Drug, and Cosmetic Act section 502(e)(1)(B) required prescription drug manufacturers to print on labels, advertising and other printed material the established name of the drug in type at least half as large as the print used for the proprietary name of that drug. The FDA followed APA rulemaking procedures of notice and opportunity and issued regulations to that effect but stated this cross-referencing must be done every time the proprietary name was printed. Ps disputed this regulation and asserted that its requirements to print the established name every time the proprietary name was used exceeded the authority of the section. The present action was brought by a group of 37 individual drug manufacturers and by the Pharmaceutical Manufacturers Association, of which all the petitioner companies are members, and which includes manufacturers of more than 90% of the Nation's supply of prescription drugs. They challenged the regulations on the ground that the Commissioner exceeded his authority under the statute. The District Court, on cross-motions for summary judgment, granted the declaratory and injunctive relief sought, finding that the statute did not sweep so broadly as to permit the Commissioner's 'every time' interpretation. The Court of Appeals for the Third Circuit reversed without reaching the merits of the case. The Court of Appeals reversed on jurisdictional grounds holding that the act precluded court review of the regulations prior to enforcement and that no case or controversy was presented.

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