Kefauver-Harris Act

The Kefauver-Harris Act in the USA, after the thalidomide catastrophe, is a good example of response to crisis. Such post hoc legislation results in differential oversight of different types of agents. 

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. 

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

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

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. 

Although the emphasis on validation began in the late 1970s, the requirement has been around since at least the 1963 CGMP regulations for finished pharmaceuticals. The Kefauver-Harris Amendments to the FD C Act were approved... 

Tragedy in the United States was averted by Dr. Kelsey s efforts. Her refusal to approve the thalidomide NDA without further proof of safety occurred just as news from Europe revealed that thalidomide was responsible for a birth defect that caused infants to be born with flipper-like limbs. This near miss in the United States led to passage of the 1962 Kefauver-Harris Amendments to the 1938 act. These amendments established requirements that testing for both safety and proof of drug efficacy had to be conducted in well-controlled clinical trials before an NDA could be approved and a drug allowed to reach the market (Bren, 2001). 

The requirement that drugs be both effective and safe did not become law until 1962. The Kefauver-Harris amendment to the Food, Drug, and Cosmetic Act passed in 1962 required the FDA to review all drugs released after 1938 for effectiveness as well as safety. This program established the Drug Efficacy Study Implementation (DESI) and the job was assigned to the National Academy of Sciences—National Research Council, which reviewed the data presented for each drug that had been submitted to the FDA. 

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