Kefauver

In 1962, amendments to the U.S. Federal Food, Dmg and Cosmetic Act (Kefauver-Harris amendments) promulgated regulations concerning the requirements for premarketing approval by the FDA. This legislation estabUshed requirements of proof of both safety and therapeutic efficacy and strict control of human clinical testing, for example, which have extended the time and cost to market a new dmg. Thus, whereas approximately 40 new dmgs were marketed annually from 1948 to 1962, this number had fallen to 12 by 1966. 

Kefauver-Harris Drug Amendments are passed. These require drug manufacturers to prove... 

Kefauver-Harris Amendments, Public Law (PL) 87-781, 87th Congress, Oct. 10, 1962. 

A. Federal Food, Drug, and Cosmetic Act of 1938 and the Kefauver-Harris Drug Amendment of 1962... 

Passage of major amendments (the Kefauver Bill) to the 1938 FDCA, which... 

A minor precedent for premarket testing of chemicals in the 1938 law had been established, on a voluntary basis, shortly after the 1906 law had gone into effect, with respect to coal-tar dyes used to color foods (98). The new drugs clause of 1938, in its turn, became a more significant precedent for later laws requiring the establishment of safety before the release of pesticide chemicals (1954), food additives (1958), color additives (1960), and medical devices (1976) (99, 100). In 1962, by the Kefauver-Harris Amendments, the Congress added the requirement that proof of efficacy be demonstrated before a new drug could be released. 

Since the Kefauver-Harris Amendmenf was adopted in 1962, pharmaceutical manufacturers have been held responsible by the FDA for providing new medications fhaf are bofh safe and effective. In addition to the Kefauver-Harris Amendment, the Belmont Report (written in 1979), established the ethical principles and guidelines for conducting research. The FDA requires that clinical trials be conducted in compliance with a protocol that has been... 

The Kefauver-Harris Amendment to the Food and Drug Act required that drugs be proven safe before put on the market. 

Flollister LE, Page IFI, Pfeiffer CC, Visscher MB. (1968). The Kefauver-Flarris amendments of 1962 a critical appraisal of the first five years. J Clin Pharmacol J New Drugs. 8(2) 69-73. 

The Food Drug Administration has the responsibility for the premarket clearance of all animal drugs. The 1958 food additive amendment to the Federal Food, Drug Cosmetic Act requires sponsors to demonstrate the safety of their products. The Kefauver-Harris amendment of 1962 requires the sponsors to demonstrate, in addition to safety, the efficacy of their drugs. Safety implies safety to the animal as well as to the consumers of animal products. The role of the Center for Veterinary Medicine in the premarket approval process is to establish conditions of drug use and to establish the allowable tolerances for drug residues in animal-derived food products. 

The products already on the market on 1 September 1971, the date for implementation of the Medicines Act, were given the Product Licences of Right (PLR) that were subject to a review process at a later date. This proposal for review of PLRs is reminiscent of the FDA contract with the National Academy of Sciences/National Research Council (NAS/NRC) in 1966, to evaluate the effectiveness of some 4000 different drug formulations approved on the basis of safety alone between 1938 and 1962 - the year of the Kefauver-Harris Amendment. 

Krantz JC Jr. New drugs and the Kefauver-Harris amendment. J Clin Pharmacol 1966 6 77-9. 

Kefauver-Harris Amendment This law dealt with the effectiveness of new drugs, ft required drug manufacturers to prove that their drugs were not only safe, but effective as well. 

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