Food and Drug Administration - Definition and Overview

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.

Recent Controversies over drug approval

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 that drug. If the drug is extremely popular, this motivates other companies to invent their own drugs that are different, but accomplish the same effect (because a drug is patented, they cannot produce the exact same drug). For example, Cialis was created because of the popularity of Viagra. However, the question is, when new, competing substances come out should they be approved, not because of their absolute safety, but because of their relative safety compared to an approved drug. 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.

Criticism of the FDA

Many economists, including Milton Friedman, Daniel B. Klein and Alexander Tabarrok, argue that the goal of protecting the public from unsafe and useless drugs conflicts with the goal of developing and introducting new drugs quickly. See for example http://www.fdareview.org/.

Friedman (1979) argues that the FDA does more harm than good. Any official in the FDA charged with approving or disapproving a new drug can make two errors. The first error is to approve a drug that has deadly or harmful side effects in a large number of people. If you make this error, like aproving a thalidomide, you will be blasted by the news media, and your reputation will be ruined.

The second error an FDA official can make is to refuse approval of a drug that is capable of saving many lives or relieving great distress and that has no untoward side effects. If you make the second error, who will know it? The people whose lives might have been saved will not be around to protest, and their families will have no way of knowing that thier loved ones lost their lives because of the "caution" of an unknown FDA official.

The following table from http://www.fdareview.org/incentives.shtml illustrates the two types of error and the reason for systematic bias toward type 2 errors.

Friedman notes that the harm the FDA causes results from the nature of the bureaucracy and would happen even the best intentioned and benevolent individuals in charge: "With the best will in the world, you or I, if we were in that position, would be led to reject or postpone approval of many a good drug in order to avoid even a remote possibility of approving a drug that will have newsworthy side effects?"

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 Naval Ordnance Laboratory White Oak site was taken over by the FDA to become its new headquarters.

Related Legislation

• 1938 — Federal Food, Drug, and Cosmetic Act
• 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
• 1992 — Prescription Drug User Fee Act PL 102–571

External links

• http://www.fda.gov/
• http://www.fdareview.org/
• End the FDA's Monopoly by David R. Henderson (http://www-hoover.stanford.edu/pubaffairs/we/2004/henderson02.html)

Articles

• US drug safety checks 'slack' (http://news.bbc.co.uk/2/hi/business/4024195.stm)

References

• Friedman, Milton & Rose (1979). Free to Choose. New York: Harcourt Brace Jovanovich. ISBN 0-15-133481-1.