Drug Efficacy Amendment

Kefauver-Harris Amendment (Drug Efficacy Amendment)... 

Upjohn V Finch upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy. FDA requires the first patient package insert. 

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. 

Kefauver-Harris Drug Amendments passed to ensure drug efficacy and greater drug safety in response to the thalidomide birth defects disaster. 1965 Drug Abuse Control Amendments are enacted to deal with problems of abuse of depressants, stimulants, and hallucinogens. 

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. 

In 1962, amendments to the Federal Food, Dmg, and Cosmetic Act added a proof-of-efficacy requirement to new drug approvals before that time, the FDA approved drugs for safety only. As a result of the amendments, brand-name companies are required to prove that new drugs are safe and effective prior to FDA approvd. To prove safety and efficacy, brand-name companies are required to conduct tests on humans ( clinical trials ) and to submit those results to the FDA with their new drug application (NDA). 

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. 

These findings were disputed by Vernon and Gusen (1974), who instead report for the 1965-1970 period that larger firms were better at innovation than smaller firms (p. 294). To be sure, as those authors acknowledge, the latter period followed the introduction of the 1962 Drug Amendments that required demonstrations of efficacy as well as safety for the introduction of a new drug, while my earlier study preceded the new law. A possible... 

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