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.
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
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.
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.[3] The bill by U.S. SenatorEstes Kefauver, of Tennessee, and U.S. RepresentativeOren Harris, of Arkansas, required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval. The majority of the tragic birth defects that occurred were in other countries because Thalidomide had not been approved for use in the United States. However, samples were distributed to physicians in the US and 17 birth defects were attributed to its use.[4]Frances Oldham Kelsey was the FDA reviewer who refused to approve Thalidomide for use.
It introduced a "proof-of-efficacy" requirement for the first time.[1] 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.
The law was signed by President John F. Kennedy on October 10, 1962.
Effectedit
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, and Canada,[5] 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 Johns Hopkins School of Medicine, 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.
^ abPeltzman, 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.
^O'Reilly, James, Jurisdiction to Decide an Agency's Own Jurisdiction: The Forgotten Tale of the Hynson Quartet, Administrative Law Review, Vol. 58, No. 4 (Fall 2006), pp. 829-843 (15 pages).
^. www.fda.gov. Archived from the original on 2019-05-07.
^Webb JF (November 1963). "Canadian Thalidomide Experience". Can Med Assoc J. 89 (19): 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 amendment after sixteen years, Mil Med. 1978 Dec;143(12):883.
External linksedit
50 Years: The Kefauver-Harris Amendments from the U.S. Food and Drug Administration
kefauver, harris, amendment, drug, efficacy, amendment, 1962, amendment, federal, food, drug, cosmetic, drug, amendments, 1962long, titlean, protect, public, health, amending, federal, food, drug, cosmetic, assure, safety, effectiveness, reliability, drugs, au. The U S Kefauver Harris Amendment or Drug Efficacy Amendment is a 1962 amendment to the Federal Food Drug and Cosmetic Act Drug Amendments of 1962Long titleAn 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 NicknamesDrug Efficacy AmendmentKefauver Harris AmendmentEnacted bythe 87th United States CongressEffectiveOctober 10 1962CitationsPublic law87 781Statutes at Large76 Stat 780CodificationActs amendedFederal Food Drug and Cosmetic ActTitles amended21 U S C Food and DrugsU S C sections amended21 U S C ch 9 301 et seq Legislative historyIntroduced in the Senate as S 1552 by Estes Kefauver D TN on July 19 1962Committee consideration by Senate Judiciary CommitteePassed 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 1962It 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 Contents 1 Background 2 Effect 3 See also 4 References 5 External linksBackground editThe 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 3 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 birth defects that occurred were in other countries because Thalidomide had not been approved for use in the United States However samples were distributed to physicians in the US and 17 birth defects were attributed to its use 4 Frances Oldham Kelsey was the FDA reviewer who refused to approve Thalidomide for use It introduced a proof of efficacy requirement for the first time 1 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 The law was signed by President John F Kennedy on October 10 1962 Effect editThe 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 and Canada 5 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 Estes Kefauver considered the Amendment his finest achievement in consumer protection citation needed Louis Lasagna then a prominent clinical pharmacologist at the Johns Hopkins School of Medicine 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 See also editCriticism 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 goodsReferences edit a b 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 O Reilly James Jurisdiction to Decide an Agency s Own Jurisdiction The Forgotten Tale of the Hynson Quartet Administrative Law Review Vol 58 No 4 Fall 2006 pp 829 843 15 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 19 987 92 PMC 1921912 PMID 14076167 Sources Abood R R amp 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 External links edit50 Years The Kefauver Harris Amendments from the U S Food and Drug Administration Drug Amendments Act of 1962 Enrolled Acts and Resolutions of Congress at the U S National Archives and Records Administration Retrieved from https en wikipedia org w index php title Kefauver Harris Amendment amp oldid 1177033729, wikipedia, wiki, book, books, library,
