Food and Drug Administration
FOOD AND DRUG ADMINISTRATION
The U.S. Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services, advances the nation's welfare by
The weakness of the law was fully revealed in 1937, when a widely marketed toxic elixir of sulfanilamide killed 107 people, mostly children. Following another storm of public indignation, Congress passed the Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA), which completely overhauled and greatly broadened the FDA's powers and responsibilities. The law's key provisions required new drugs to be shown to be safe before they could be marketed; defined adulterated and misbranded food; authorized standards of identity, quality, and fill-of-container for foods; and authorized the FDA to inspect facilities producing regulated products.
Even these sweeping provisions have failed at times to protect the public against new hazards, and Congress has strengthened the FFDCA by passing more than 200 amendments. Landmark additions to the act include the Kefauver-Harris Drug Amendments of 1962, which required manufacturers to prove that their medicines are effective as well as safe; the Medical Device Amendments of 1976, which extended similar requirements to medical equipment; and the FDA Modernization Act of 1997, which directed the agency to carry out its mission in close cooperation with other public health groups, both in the United States and abroad.
At the end of the twentieth century, the FDA's mandated responsibilities included ensuring the safety of the entire food supply (except for meat and poultry, which remained under the USDA's purview); making certain that all drugs, medical devices, vaccines, blood products, tissues for transplantation, and animal drugs and feeds are safe and effective when properly used; and assuring that cosmetics and devices that emit radiation do no harm. All of these products, which are manufactured, transported, warehoused, and retailed by more than 110,000 establishments, are worth about $1 trillion a year, or a fifth of all consumer expenditures. In 2000, the per capita cost of this protection was less than two cents a day.
The head of the FDA is the Commissioner of Food and Drugs, a presidential appointee who is confirmed by the Senate. About two-thirds of the FDA's 9,000 employees work in five product-focused centers. The FDA's Center for Food Safety and Applied Nutrition primarily ensures that food products do not contain hazardous pesticides or other contaminants, and that they are truthfully labeled. This center also works with producers to ascertain that genetically modified foods do not present a health risk. The other four centers— Evaluation and Research; Biologics Evaluation and Research; Devices and Radiological Health; and Veterinary Medicine—develop standards for product safety and effectiveness and make sure that the standards are met by reviewing the manufacturers' applications before allowing new health care products on the market.
In general, the application data must be derived from rigorously designed and controlled clinical trials that, for most drugs, include toxicity tests in animals, safety tests in healthy subjects, and studies of safety and effectiveness in large groups of patients. For the most complex drugs and devices, the FDA also relies on the recommendations of advisory panels of outside specialists who evaluate the products in public meetings. To be approved, each product's benefits must outweigh the risks of its use. Continued compliance of marketed products with FDA standards is ensured by the agency's inspectors, investigators, and food safety officers that are located in 174 communities from coast to coast and in Puerto Rico and by twelve national FDA laboratories.
The fast-growing U.S. dependence on imported food and health care products; the global spread of AIDS (acquired immunodeficiency syndrome); mushrooming international tourism; and the development of new, highly sophisticated food, pharmaceutical, and device technologies in the late 1900s greatly increased the complexity of the FDA's mission. To meet the new challenges, the FDA has developed strong scientific ties with academia and the private sector and worked closely with foreign
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—— Milestones in U.S. Food and Drug Law History. Available at http://www.fda.gov/opacom/backgrounders/miles.html.
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