Harris-Kefauver Amendments, Food

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

Federal Register. Title 21 CRF 310, Kefauver-Harris Drug Amendments of the Food, Drug and Cosmetic Act, 1962. 

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 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. 

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 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. 

Manufacturers only had to prove that their medication is nontoxic to sell their medication. With the 1962 Kefauver-Harris Amendment to the 1938 Food, Drug, and Cosmetic Act, manufacturers also had to prove the effectiveness of the medication before it could be administered to patients. In addition, the 1962 Kefauver-Harris Amendment authorized the Food and Drug Administration, who oversees the pharmaceutical industry, to... 

Figure 1. President John Kennedy signing the 1962 Kefauver-Harris Amendments to the Food and Drug Act into law. Fie is handing the pen to Estes Kefauver Frances Kelsey is second from the left. (FDA Flistory Office)...

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