Kefauver–Harris Amendment

Drug Amendments of 1962
Long title	An act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety, effectiveness, and reliability of drugs, authorize standardization of drug names, and clarify and strengthen existing inspection authority; and for other purposes.
Nicknames	Drug Efficacy Amendment; Kefauver–Harris Amendment;
Enacted by	the 87th United States Congress
Effective	October 10, 1962
Citations
Public law	87-781
Statutes at Large	76 Stat. 780
Codification
Acts amended	Federal Food, Drug, and Cosmetic Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections amended	21 U.S.C. ch. 9 § 301 et seq.
Legislative history
	Introduced in the Senate as S. 1552 by Estes Kefauver (D–TN) on July 19, 1962; Committee consideration by Senate Judiciary Committee; Passed the Senate on August 23, 1962 (78–22); Passed the House on August 23, 1962 (passed); Reported by the joint conference committee on October 4, 1962; agreed to by the House on October 4, 1962 (347–88) and by the Senate on October 4, 1962 (passed); Signed into law by President John F. Kennedy on October 10, 1962;

The U.S. Kefauver–Harris Amendment, "Drug Efficacy Amendment," or Drug Amendments of 1962 is an amendment to the Federal Food, Drug, and Cosmetic Act. The amendments were designed to strengthen drug regulation in the United States due to the thalidomide tragedy, which demonstrated the risks of unsafe and ineffective medications. The law required drug manufacturers to prove drugs were safe and effective, expanded the Food and Drug Administration (FDA) oversight over drug manufacturers, and set rules for drug advertisements and labels to ensure public health safety. The bill underwent the legislative process of being amended and debated in Congress until the Drug Amendments of 1962 was signed into law by President John F. Kennedy on October 10, 1962.