Drug Safety

Drug Safety

America's committment to drug safety began in 1906, when the agency that would become the Food and Drug Administration (FDA) was created. Our drug safety laws have been improved throughout the intervening century, but the most important addition was the Food, Drug, and Cosmetic Act of 1938, which granted the agency real power for the first time. Most importantly, the 1938 act was the first law to require the testing of drugs before they were sent to market. It also banned drugs that didn’t list all their active ingredients and forced companies to truthfully describe the effects of their products. (Before the FDA got to it, Listerine advertised its ability to cure tuberculosis.) 

Commentary

How a Shadow Drug Industry Tries to Avoid Regulation

April 16, 2013

Behind the Meningitis Outbreak: Pharmacies fought FDA regulation

October 19, 2012

Cry Wolf Quotes

If this bill should become law, we will be forced to cancel immediately every line of advertising.

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One patent-medicine maker (unnamed) had written to multiple newspapers with the warning.

If a murderer kills you, it’s homicide. If a drunk driver kills you, it’s manslaughter. If the FDA kills you, it’s just being cautious…Our own federal government’s bureaucratic and apparently unaccountable Food and Drug Administration [blocked drug approvals while Americans] died in agony from a disease other nations controlled for years.

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The Washington Legal Foundation (WLF) newspaper ads in publications, including the Wall Street Journal and the New York Times.
06/21/1993 | Full Details | Law(s): Abolish the FDA

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.

Resources

Consumer Federation of America defends the consumer interest in fields ranging from housing and financial services to food safety. 

The U.S. Food and Drug Administration

(FDA) is the federal agency responsible for the testing and regulation of food, drugs, cosmetics, and medical devices.

Alliance for A Stronger FDA tries to strengthen the Food and Drug Administration by increasing the appropriations allotted to the agency.

The Center for Science in the Public Interest, since 1971, has been a leading advocate for nutrition and health, food safety, alchohol policy, and sound science.