Kefauver-Harris Amendment of 1962

Kefauver-Harris Amendment of 1962

The 1962 Kefauver-Harris Amendment origins lie in Senate Anti-Trust and Monopoly Subcommittee Chairman Estes Kefauver’s (D-TN) hearings into the drug industry. The hearings revealed staggeringly high profits and a shockingly low level of accountability. The Kefauver hearings depicted an industry out of control: where the costs of medicine were far higher than expenses warranted, where many pharmaceutical ads were blatantly misleading or overstated, research was less than rigorously carried out, and cheaper generic drugs were hard to access. The Keafauver-Harris bill leveled controls on the pharmaceutical companies, forcing them to tell doctors about the side-effects of their products, requiring companies to notify the FDA before product testing on humans, requiring that drug companies prove their drugs worked as claimed (while removing those that didn’t from the market), and forcing companies let their patents run out after a certain number of years, thus allowing their products to be sold cheaply as generic drugs. In short, the law expanded the FDA’s authority to regulate drugs for both safety and efficiency.

Commentary

US Capitol building

Darrel Issa’s Government Handover

January 05, 2011

Cry Wolf Quotes

I feel that additional legislation…is only helpful to large industry and has a tendency to throttle small industry...

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Edward J. Breck, president of John H. Breck Inc. (a major cosmetics firm), Testimony, House Committee on Interstate and Foreign Commerce hearings.

The proposal is…apparently directed against an uncooperative small minority, yet, these are the exactly the businesses that would be least likely to maintain adequate or accurate records. Thus, the privacy of the great majority of respectable businessmen is to be prejudicially invaded because of the misbehavior of a small minority….It cannot be too strongly stated that inspection of these factories as provided by this section , by outsiders, can expose to the world trade secrets….This technology is, in the truest sense, the property of its owners.

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Franklin Depew, Chairman of the Food, Drug, and Cosmetic section of the New York Bar Association, Testimony, House Committee on Interstate and Foreign Commerce. (From the June 19-22, 1962)

If overcautious and restrictive Government regulation had blocked [penicillin] testing and introduction twenty years ago, some lives would have been saved while a multitude of lives would have been lost.

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Eugene M. Beesley, Chairman of the Board of Directors of the Pharmaceutical Manufacturers Association (PMA). Testimony, House Committee on Interstate and Foreign Commerce hearings.

It should be enough if responsible and qualified clinicians have found that the drug produces the claimed effect…FDA should not be the arbiter of such conflicting views which necessarily involve large elements of subjective opinion by qualified scientists. Otherwise, we face the serious danger to medical progress inherent in a central authority where conflicting viewpoints in medicine will be indirectly resolved, as they are under a totalitarian system, and we run the very grave risk of recasting our system in a sterile, foreign mold…

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Theodore Klumpp, member of the board of directors of the Pharmaceutical Manufacturers Association (PMA) and a former FDA medical director. Testimony, House Committee on Interstate and Foreign Commerce (June 19-22, 1962.)

Backgrounders & Briefs

Good Rules: Ten Stories Of Successful Regulation

Demos looks at ten laws and rules that we take for granted.