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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.

Contents

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.

Drug Is
Beneficial

Drug Is

Harmful

FDA Allows

the Drug
Correct Decision

Type 1 Error:
Allowing a harmful drug.


Victims are identifiable and traceable, and might appear on Oprah.

Error is self-correcting

FDA Does Not

Allow the Drug

Type 2 Error:
Disallowing a beneficial drug. Victims are not identifiable and scarcely even acknowledged in the abstract.

Error is not self-correcting
Correct Decision

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.

Related Legislation

External links

Articles

References

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

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The FDA is monitored by the Department of Health and Human Services (DHHS), which itself is part of the Executive Office branch of the United States government.
The FDA is divided into five major Centers: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).
The FDA was also criticized for banning the essential amino acid Tryptophan after a manufacturing incident in Japan contaminated one batch.
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