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
Behind the Meningitis Outbreak: Pharmacies fought FDA regulation
Cry Wolf Quotes
I feel that additional legislation…is only helpful to large industry and has a tendency to throttle small industry...
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…
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.
Mr. Gingrich recently denounced the FDA as a 'Stalinistic' agency. While Mr. Gingrich's comment may be hyperbolic, there are some interesting parallels between Dr. Kessler's responses to the FDA's problems and Josef Stalin's response to the problems of the Soviet planned economy…. Dr. Kessler, like Stalin, instead of fixing the obvious problems, has issued one denunciation after another of those who opposed or disagreed with him…. Stalin sought to solve the problems of defects and crashes among advanced Soviet Air Force fighter planes by executing some of the aircraft engineers; Dr. Kessler has responded to the occasional problems of new medical devices with a de facto regulatory pogrom that is exiling the industry.
Related Laws and Rules
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.
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.
