FDA

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The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. The FDA is headed by acting commissioner Dr. Lester Crawford.^[1]

The FDA is overseen 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). Each center has its own origins and history, the oldest being the Center for Biologics, which oversees blood products, vaccines and newer therapeutics related to stem cells and gene therapy. The Center for Drugs, the center that receives the most public scrutiny, regulates pharmaceutical medicines.

The over-arching mandate of the FDA is to regulate the multitude of medicinal products in a manner that ensures the safety of the American public and the efficacy claims (label) of marketed drugs.

One aspect of its jurisdiction over food is regulation of the content of health claims on food labels. However, because regulating the content of labels implicates the First Amendment, FDA must balance concerns about the public health with the right to free speech. Dan Troy, a lawyer who was Chief Counsel of the Food and Drug Division from August 2001 to November 2004, raised the agency's focus on First Amendment issues.

FDA and the public

According to the Small Business Guide to FDA, "Anyone may request or petition FDA to change or create an Agency policy or regulation under 21 CFR Part 10.30." This is called a Citizen's Petition and it is one method used to challenge specific approvals by the FDA.^[2]

Recent controversies over drug approval

One of the key issues of drug safety dealt with by the FDA, and responsible for much recent controversy, is related to the concept of patents. When a patent is awarded, the drug's creator is given exclusive manufacturing rights. If the drug is extremely popular, this motivates other companies to invent their own (different) drugs which 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". Only people who were ignorant of that higher risk would take drug b - or people who bought it because it was cheaper, which would create an unhealthy conflict between profit and health.

This phenomenon 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 continuously monitoring drug safety.

The FDA charges fees to pharmaceutical companies that wish to "expedite" the drug approval process. The is considered by many to be a conflict of interest, as the companies who are supposed to be regulated by the FDA are those who are paying them to speed up approvals. They reason that this "pay-off" to expedite the process may sacrifice the quality of studies.

Incentive to delay new drugs?

A controversial concept. Economists Milton Friedman, Daniel B. Klein and Alexander Tabarrok are three economists who argue that the FDA causes harm. Many economists who study the FDA are critical.^[3]

Friedman (1979) notes that the FDA can make two types of errors.^[4] Type 1 is to approve a drug that has deadly or harmful side effects in a large number of people. If you make this error, like approving a thalidomide, you will be blasted by the news media, and your reputation will be ruined.

Type 2 is refusing 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 a type 2 error, few will know it, as the people whose lives might have been saved will not be around to protest, and their families will have no way of knowing that their 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 theorizes that the harm the FDA causes results from the nature of the bureaucracy and would happen even with 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?"

The FDA has also been criticized for intervening in the nutritional supplement business. It has conducted at least one well-publicized raid on an establishment that sold and manufactured such products, the "Life Extension Foundation," which is a significant player in the industry. A "battering ram" was said to be used to break down into warehouses and the glass doors of their retail store were "smashed." [5]

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 aportioned to the FDA to become its new headquarters. However, budget reductions have delayed the move to White Oak for many FDA offices.

FDA heads and G.D. Searle & Company

Many heads of the FDA left the FDA and joined G.D. Searle & Company (the company that owns Nutrasweet (aspartame)) for higher paying jobs. In some cases, the opposite occurred. These transferrs have been criticized as a union of government and big business, and a legal form of bribery of government (FDA) officials.

• Current Secretary of DefenseDonald Rumsfeld was president & CEO of G.D. Searle & Company.
• Arthur Hull Hayes was a defense contractor, then head of the FDA (FDA Commissioner)(1981-1983), and then G.D. Searle's public-relations firm as senior medical advisor.
• Several of members of the FDA board left their jobs after Stevia (aspartame's main competitor) was banned by the FDA in 1991. They were all hired at the Nutrasweet Co. in higher pay jobs, according to national (government) records.
• In 1999, Dr. Michael Friedman quit the FDA when Jane Henney was selected to become the permanent FDA commissioner. Friedman signed on with G. D. Searle as a senior vice president at a purported $500,000 a year.

Related legislation

• 1938 — Federal Food, Drug, and Cosmetic Act
• 1944 — Public Health Service 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

Articles

• US drug safety checks 'slack'

References

1. ^  CHI World Pharmaceutical Congress 2005 Website and final agenda in print form. Verified 03-07-2005.
2. ^  How to Petition the FDA. Retrieved 2005-03-20.
3. ^  FDAReview.org
4. ^  Friedman, Milton & Rose (1979). Free to Choose. New York: Harcourt Brace Jovanovich. ISBN 0-15-133481-1.