United States v. Rutherford, 442 U.S. 544 (1979)

U.S. Supreme Court decision holding that the Federal Food, Drug, and Cosmetic Act's premarketing safety-and-effectiveness approval requirement applies to drugs used by terminally ill patients exactly as it applies to any other drug, rejecting a Tenth Circuit ruling that those requirements did not sensibly apply to terminal cancer patients seeking laetrile. The FDA Commissioner had found, after formal administrative hearings (opinion issued 29 July 1977, 42 Fed. Reg. 39768, 39775-39787), that laetrile in its various forms was a new drug not generally recognized among experts as safe and effective, and that no adequate well-controlled scientific studies established its safety or effectiveness; the Supreme Court's opinion left that finding standing and reversed the lower courts' injunction permitting laetrile use by certified terminally ill patients. Amicus briefs opposing the government were filed for, among others, the McNaughton Foundation of California. Findlaw case text fetched directly; case citation and holding cross-confirmed via Justia case listing and Library of Congress U.S. Reports catalog record (loc.gov/item/usrep442544/).