Kefauver Harris Amendment
|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 standardiztion of drug names, and clarify and strengthen existing inspection authority; and for other purposes.|
|Enacted by the||87th United States Congress|
|Effective||October 10, 1962|
|Stat.||76 Stat. 780|
|Act(s) amended||Federal Food, Drug, and Cosmetic Act|
|Title(s) amended||21 U.S.C.: Food and Drugs|
|U.S.C. section(s) amended||21 U.S.C. ch. 9 § 301 et seq.|
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, 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.
The amendment was a response to the Thalidomide tragedy, in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy. The bill by U.S. Senator Estes Kefauver, of Tennessee, and U.S. Representative Oren Harris, of Arkansas, required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval. It should be noted that Thalidomide had not been approved for use in the United States and that the tragic birth defects that occurred were in other countries. Frances Oldham Kelsey was the FDA reviewer who refused to approve Thalidomide for use.
It introduced a "proof-of-efficacy" requirement, that was not present before. In addition, the Amendment required drug advertising to disclose accurate information about side effects and efficacy of treatments. Finally, cheap generic drugs could no longer be marketed as expensive drugs under new trade names as new "breakthrough" medications, as they were prior to the amendment.
The law was signed by President John F. Kennedy on October 10, 1962.
The Kefauver Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated. Before the Thalidomide scandal in Europe, U.S. drug companies only had to show their new products were safe. After the passage of the Amendment, an FDA New Drug Application (NDA) would have to show that a new drug was both safe and effective (previously the 1938 Food, Drug and Cosmetic Act was the main law that regulated drug safety). Informed consent was required of patients participating in clinical trials, and adverse drug reactions were required to be reported to the FDA.
The Drug Efficacy Study Implementation was begun to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.
Louis Lasagna, then a prominent clinical pharmacologist at the University of Rochester, advised Congress about the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment.
The law also exempted from the "Delaney clause" (a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938) certain animal drugs and animal feed additives shown to induce cancer, but which left no detectable levels of residue in the human food supply.
- Frances Oldham Kelsey
- Regulation of therapeutic goods
- Federal Food, Drug, and Cosmetic Act
- Durham-Humphrey Amendment
- Drug Efficacy Study Implementation
- Criticism of the FDA
- Directive 65/65/EEC1 (Europe)
- 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 (in English). U.S. Food and Drug Administration.
- Abood, R.R., & Brushwood, D.B. (1994). Pharmacy practice and the law. Gaithersburg, MD: Aspen Publishers, Inc.
- Krantz JC Jr., New Drugs and the Kefauver-Harris Amendment, J New Drugs, 1966, Mar-Apr;6(22):77-9
- Krantz JC Jr., The Kefauver-Harris amendment after sixteen years, Mil Med. 1978 Dec;143(12):883.