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Home > Food and Drug Administration


The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologic s and blood products in the United States.

One aspect of its jurisdiction over food is regulation of the content of health claims on food labels.

One of the key issues of drug safety dealt with the FDA, and responsible for much recent controversy, is related to the concept of patents. The patenting of a drug gives the creator exclusive right to manufacture those drugs, and if the drug is extremely popular, this motivates other companies to try to invent drugs of their own that are different but accomplish the same effect (because they can't produce the exact same drug in order to compete because it's patented). For example, Cialis was created because of the popularity of Viagra. When new, competing substances come out however, the question is should they be approved, not because of their absolute safety, but because of their relative safety compared to a drug that's already out that does the same thing. For example, say "drug b" was created to compete with "drug a". Now if "drug b" was the first one out, and it had a 5 percent chance of heart attack, the FDA might find this acceptable. However if "drug a" was already out, and it had a 2.5 percent chance of heart attack, then the FDA would be reluctant to approve "b" because the only people who would seemingly take drug b would either be ignorant of that higher risk or might buy it because its cheaper, which creates an unhealthy conflict of interest between profit and health. This phenonemon is at the center of a present controversy over the recall of Vioxx, which is causing more attention to be brought to the FDA.

David J. Graham, a scientist with the FDA, says he was pressured by his supervisors not to warn the public about dangers of drugs like Vioxx, and so recommended to congress that a separate agency be created which is dedicated to continously monitoring drug safety.

1 History

The FDA does not protect consumers as much as many people might think. See Leavitt, Fred (2003) The REAL Drug Abusers. Rowman & Littlefield.

2 Related Legislation



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