Cooper Laboratories, Inc. v. Commissioner, Federal Food and Drug Administration

J. SKELLY WRIGHT, Circuit Judge:

To be marketed in interstate commerce under the Food, Drug and Cosmetic Act, a drug must generally be covered by a “new drug application” (NDA) approved by the Food and Drug Administration (FDA).1 In 1944 the FDA approved an NDA for Protamide, an injectible colloidal solution of dena*774tured proteolytic enzyme, upon a finding that the drug was safe for human use, and Protamide was thereafter marketed for symptomatic treatment of herpes zoster (popularly known as shingles), ophthalmic herpes zoster, tabes dorsalis, and neuritis.2 The 1962 amendments to the Act3…