Larry Leon Chaney v. Margaret M. Heckler, as Secretary of Health and Human Services

J. SKELLY WRIGHT, Circuit Judge:

In the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. (1976 & Supp. V 1981), Congress has required the Secretary of Health and Human Services or her delegate, the Commissioner of the Food and Drug Administration (FDA),1 to assure that all “new drugs” are “safe and effective” for use under the conditions prescribed, recommended, or suggested on the official labeling.2 Id. § 355(a). Before the Commissioner can allow a “new drug” to be distributed in interstate commerce, FDA must assure the safety of the drug and the adequacy of its branding. Id. §§…