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Food and Drug Administration - Organization

fda azt aids approval

The FDA carries out its activities through a number of subdivisions. The Center for Drug Evaluation and Research regulates the safety, effectiveness, and labeling of all prescription and over-the-counter drugs intended for human use. It also monitors drug advertising for accuracy, ensures the safety and rights of patients in drug studies, and distributes information on drug products to the medical community and the public.

The Center for Biologics Evaluation and Research regulates biological products, which include blood, vaccines, human tissues, and drugs derived from living organisms. It coordinates an AIDS program, which works to develop an AIDS vaccine and AIDS diagnostic tests. It also conducts research on the safety of blood and blood products and inspects manufacturing plants to ensure compliance with FDA standards.

The Center for Food Safety and Applied Nutrition develops regulations related to food, food additives and colorings, and cosmetics. The Center for Devices and Radiological Health seeks to ensure the safe use of potentially hazardous radiation such as that produced by X rays. It conducts research into the effects of exposure to radiation-producing medical devices and develops manufacturing standards for such devices.

The Center for Veterinary Medicine evaluates the safety of drugs and devices used on animals. The National Center for Toxicological Research assesses the biological effects of toxic chemical substances.

AZT: An Agent of Change for the FDA

Azidothymidine (AZT) is a celebrated example of speedy FDA approval of a new drug. The unusually swift approval of AZT during the early years of the AIDS (ACQUIRED IMMUNE DEFICIENCY SYNDROME) epidemic led to the creation of a new FDA category, treatment investigational new drug (treatment IND), that established new procedures for more rapid and flexible drug approval.

The pharmaceutical company Burroughs Wellcome first presented AZT as a new drug to the FDA in June 1985. Public fear of AIDS had increased dramatically during the previous few years, as had protests by AIDS activists who complained of slow FDA movement with regard to promising new treatments. Keenly aware of the need for swift decision making in the face of the deadly AIDS disease, the FDA approved phase 1 clinical trials of the drug within one week of the initial application.

Phase 1 testing of AZT, between July and December 1985, was promising, and phase 2, involving 300 patients in placebo-controlled trials, began in February 1986. After six months, 19 of the 137 patients in the group taking the placebo had died, whereas only 1 of 145 in the group taking AZT had died. The results were encouraging enough for the FDA to forgo further testing. The group taking the placebo was switched to AZT, and phase 3 testing, traditionally the most important step in clinical trials, was deemed unnecessary.

In September 1986, the FDA authorized the treatment of patients who wanted access to AZT, even before it had given approval to the drug. By the time approval for general public use came in March 1987, some 4,000 patients had already been treated with AZT, and thus the drug was already potentially extending the lives of hundreds of people.

Taking an example from its handling of AZT, the FDA in May 1987 created the treatment IND classification to facilitate faster approval and wider distribution of promising new therapies for life-threatening diseases. The rapid approval of AZT also proved greatly encouraging to the pharmaceutical industry, which could now hope to bring AIDS drugs to market much more rapidly and at lower cost.

Other offices of the FDA include the Office of Policy, the Office of External Affairs, the Office of Management and Systems, the Office of AIDS Coordination, the Office of Orphan Products Development, and the Office of Biotechnology. The administration operates six field offices, 21 district offices, and 135 resident inspection posts throughout the United States and Puerto Rico.

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