Food and Drug Administration

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. Andrew von Eschenbach, who succeeds Dr. Lester Crawford who resigned on September 23, 2005 only two months after his final Senate confirmation.

Related Topics:
United States - Food - Dietary supplement - Drug - Cosmetic - Medical device - Biologics - Blood products - Dr. Andrew von Eschenbach - Dr. Lester Crawford - September 23 - 2005

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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.

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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. The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year. "Review teams" employ around 1,300 employees to approve new drugs. The "safety team" has 72 employees to determine whether new drugs are hurting people. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year. The FDA requires clinical testing in populations of about 3,000 people.

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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.

Related Topics:
Food - Regulation - Health claims on food labels - First Amendment

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The FDA does not pre-approve dietary supplements on their safety and efficacy, unlike drugs. In contrast, the FDA can only go after dietary supplement manufacturers after they have put unsafe products on the market. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements.

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The FDA has come under much criticism from many groups. Their regulations are blamed for things such as causing high drug prices and keeping life-saving drugs off the market. Some propose that the FDA be relegated to a voluntary inspection agency in order to remedy these problems.

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