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, biologics 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.

History

• 1927 — The "Bureau of Chemistry" is reorganized into two separate entities. Regulatory functions are located in the "Food, Drug, and Insecticide Administration", and nonregulatory research is located in the "Bureau of Chemistry and Soils".

• 1930 — The name of the "Food, Drug, and Insecticide Administration" is shortened to "Food and Drug Administration" (FDA) under an agricultural appropriations act.

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

Related Legislation

• 1951 — Food, Drug, and Cosmetics Act Amendments PL 82–215
• 1953 — Flammable Fabrics Act PL 83–88
• 1960 — Federal Hazardous Substances Labeling Act PL 86–613
• 1962 — Food, Drug, and Cosmetics Act Amendments PL 87–781
• 1965 — Federal Cigarette Labeling and Advertising Act PL 89–92
• 1966 — Fair Packaging and Labeling Act PL 89–755
• 1966 — Child Protection Act PL 89–756
• 1970 — Federal Cigarette Labeling and Advertising Act Amendments PL 91–222
• 1972 — Consumer Products Safety Act PL 92–573
• 1976 — Medical Device Regulation Act PL 94–295
• 1986 — Comprehensive Smokeless Tobacco Health Education Act PL 99–252
• 1988 — Anti—drug Abuse Act PL 100–690
• 1990 — Nutrition Labeling and Education Act PL 101–535

External link

• US drug safety checks 'slack' (http://news.bbc.co.uk/2/hi/business/4024195.stm)
• http://www.fda.gov/
• FDA reviewer: Five drugs may be unsafe (http://www.wmtw.com/Global/story.asp?S=2588254&nav=7k6rTJwp)

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