Kefauver Harris Amendment

The U.S. Kefauver Harris Amendment or Drug Efficacy Amendment of 1962 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. 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 regulations introduced a "proof-of-efficacy" requirement, that was not present before.^[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, as they were prior to the amendment.

The law was signed by President John F. Kennedy on October 10 1962. The Kefauver Harris Amendment strengthened the FDA's control of experimentation on humans and changed the way new drugs are approved and regulated. Before the Thalidomide scandal in Europe, 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 the 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.

Estes Kefauver considered the Amendment his "finest achievement" in consumer protection.

Louis Lasagna, then a prominent clinical pharmacologist at the University of Rochester, 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 proviso, of the Food Additives Amendment of 1958, animal drugs and animal feed additives shown to induce cancer, but which left no detectable levels of residue in the human food supply.

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Criticism

Some argue that the amendment has had a detrimental effects such as causing higher drug prices and delaying drug approval resulting in more lives lost than saved. Nobel prize-winning economist Gary S. Becker has written that FDA regulations make drug development so costly that "drug companies must charge high prices during the limited period when they enjoy patent protection against generic competitors" to recover their outlays. He says that a major step to reduce drug prices would be to eliminate the regulations introduced in by the amendment which raised the cost of bringing drugs to market and slowed the process.^[2] Others have argued that the cost of drug development has no direct effect on drug pricing. Writes Joseph DiMasi, an economist at Tufts University, "At the time that drug prices are determined, the associated R&D spending for a drug is a sunk cost. Basic economic logic tells us that R&D costs do not determine prices."^[3] Becker says that eliminating the regulations introduced by the Amendment would make drugs cheaper to bring to market which would in turn increase the introduction of new drugs, especially from small biotech firms that do not have the capital to invest in extended efficacy trials. Becker says that more drugs coming to market to compete with each other will result in lower prices. He says though efficacy trials would not be mandatory, "fear of lawsuits and the desire to maintain a good reputation would sometimes induce companies to conduct many trials before marketing highly invasive medicines.".^[4][2] Therefore, Becker argues, the regulations introduced in 1962 should be eliminated in order to lower the price of bringing drugs to market, so that more will be brought to market, therefore more competition and lower prices.

Cited references

See also

• Frances Oldham Kelsey
• Regulation of therapeutic goods
• Federal Food, Drug, and Cosmetic Act
• Drug Efficacy Study Implementation
• Directive 65/65/EEC1 (Europe)

References

• 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.