Bentex Pharmaceuticals, Inc. v. Richardson

RUSSELL, Circuit Judge:

This appeal turns on a construction of the Federal Food, Drug, and Cosmetic Act of 1938, as amended in 1962.1 21 U.S.C. § 301 et seq. This statute requires premarketing approval and clearance of any “new drug” by the Secretary of Health, Education and Welfare.2 The term “new drug” is defined as one “not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof * * 3 From a denial of…