Kefauver Harris Amendment Of 1962

Drug Amendments of 1962
Citations

Long championship	An act to protect the public health by amending the Federal Food, Drug, and Cosmetic Deed to assure the prophylactic, 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 Subpoena
Enacted by	the 87th United States Congress
Effective	October 10, 1962
Public law	87-781
Statutes at Big	76 Stat. 780
Codification
Acts amended	Federal Food, Drug, and Cosmetic Human action
Titles amended	21 U.S.C.: Nutrient and Drugs
U.S.C. sections amended	21 U.s.C. ch. 9 § 301 et seq.
Legislative history
Introduced in the Senate as Southward. 1552 by Estes Kefauver (D–TN) on July 19, 1962 Committee consideration past 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 Business firm on October 4, 1962 (347–88) and by the Senate on October iv, 1962 (passed) Signed into law by President John F. Kennedy on October ten, 1962

The U.Southward. Kefauver–Harris Amendment or "Drug Efficacy Subpoena" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Human action.

Information technology introduced a requirement for drug manufacturers to provide proof of the effectiveness and safe of their drugs before blessing,^[1] ^[2] required drug advertising to disclose accurate information virtually side effects, and stopped cheap generic drugs being marketed as expensive drugs under new merchandise names as new "breakthrough" medications.

Background [edit]

The amendment was a response to the thalidomide tragedy, in which thousands of children were built-in with nativity defects as a result of their mothers taking thalidomide for morning sickness during pregnancy.^[iii] 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. The majority of the tragic nascence defects that occurred were in other countries considering Thalidomide had not been canonical for utilise in the United States. However, samples were distributed to physicians in the United states and 17 birth defects were attributed to its use.^[iv] Frances Oldham Kelsey was the FDA reviewer who refused to approve Thalidomide for use.

It introduced a "proof-of-efficacy" requirement for the outset time.^[1] In addition, the Subpoena required drug ad to disclose accurate information nearly side effects and efficacy of treatments. Finally, cheap generic drugs could no longer be marketed equally expensive drugs under new trade names as new "breakthrough" medications.

The police was signed by President John F. Kennedy on October ten, 1962.

Effect [edit]

The Kefauver–Harris Amendment strengthened the U.S. Food and Drug Assistants's control of experimentation on humans and changed the way new drugs are approved and regulated. Earlier the Thalidomide scandal in Europe, and Canada,^[5] U.S. drug companies only had to prove their new products were safety. After the passage of the Amendment, an FDA New Drug Awarding (NDA) would accept to bear witness that a new drug was both safe and effective (previously the 1938 Food, Drug and Corrective Act was the main police force that regulated drug safe). 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.

Estes Kefauver considered the Amendment his "finest achievement" in consumer protection^{[ citation needed ]}.

Louis Lasagna, then a prominent clinical pharmacologist at the Johns Hopkins Schoolhouse of Medicine, brash Congress almost the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment.

The police as well 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 being food supply.

See as well [edit]

Criticism of the FDA
Directive 65/65/EEC1 (Europe)
Drug Efficacy Study Implementation
Durham-Humphrey Amendment
Federal Food, Drug, and Cosmetic Act
Frances Oldham Kelsey
Regulation of therapeutic appurtenances

References [edit]

^ ^a ^b Peltzman, Sam. An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments. The Periodical 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.Due south. Nutrient and Drug Administration.
^ O'Reilly, James, Jurisdiction to Decide an Agency's Ain Jurisdiction: The Forgotten Tale of the Hynson Quartet, Administrative Law Review, Vol. 58, No. four (Fall 2006), pp. 829-843 (fifteen pages).
^ "Kefauver-Harris Amendments Revolutionized Drug Development". www.fda.gov. Archived from the original on 2019-05-07.
^ Webb JF (November 1963). "Canadian Thalidomide Experience". Can Med Assoc J. 89: 987–92. PMC1921912. PMID 14076167.

Sources

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 subpoena subsequently xvi years, Mil Med. 1978 Dec;143(12):883.

External links [edit]

50 Years: The Kefauver-Harris Amendments from the U.South. Nutrient and Drug Administration
Drug Amendments Act of 1962, Enrolled Acts and Resolutions of Congress at the U.Due south. National Athenaeum and Records Assistants