Burroughs Wellcome Co. v. Schweiker

BUTZNER, Circuit Judge:

Burroughs Wellcome Company, a pharmaceutical manufacturer, appeals from a judgment of the district court that held that the Food and Drug Administration need not engage in notice and comment rule making before implementing a memorandum concerning approval of new drug applications (NDAs) for generic versions of drugs first marketed after 1962 that are based on reports in the scientific literature to establish the drug’s safety and effectiveness. An application for approval on this basis is termed by the industry a “Paper NDA.” The district court concluded that the FDA’s…