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 or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.

It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval,^[1]^[2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications.

^ Peltzman, Sam. An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments. The Journal of Political Economy, Vol. 81, No. 5. (Sep. - Oct., 1973), pp. 1051.
^ "Promoting Safe and Effective Drugs for 100 Years". The Kefauver-Harris Drug Amendments. U.S. Food and Drug Administration. Archived from the original on July 9, 2009.

[Peltzman,_Sam_1051-1] Peltzman, Sam. An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments. The Journal of Political Economy, Vol. 81, No. 5. (Sep. - Oct., 1973), pp. 1051.

[2] "Promoting Safe and Effective Drugs for 100 Years". The Kefauver-Harris Drug Amendments. U.S. Food and Drug Administration. Archived from the original on July 9, 2009.

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