FDA evaluates accelerated approval process. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

FDA evaluates accelerated approval process. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Common Factor. 1995 Apr;(no 10):18. Unique Identifier : AIDSLINE AIDS/95700371

Abstract: The antivirals d4T and ddC have been given accelerated approval status, providing more treatment options for persons who cannot tolerate or have developed resistance to AZT and ddI. There is controversy that these drug accelerations have been done without enough clinical data to show their proper use. Drug companies are mandated to complete trials of accelerated drugs once accelerated approval is given, and it is suggested that the Food and Drug Administration (FDA) enforce that mandate. If the drug is found to have problems during subsequent trial phases, the FDA is authorized to cancel the acceleration. Restricting access to a drug by eliminating approval is considered coercion since the only way to access the drug is through the trial; such restriction is viewed as harming both the individual and clinical research. It is believed that pharmaceutical companies and the FDA should be pressured to grant accelerated approval to the next class of anti-HIV drugs as soon as possible. It is suggested there are not enough drugs that have demonstrated safety and efficacy in clinical trials to choose from, and that the FDA must more strictly enforce responsibilities of the pharmaceutical companies after a drug receives accelerated approval.

Keywords: Acquired Immunodeficiency Syndrome/DRUG THERAPY *Antiviral Agents/THERAPEUTIC USE Clinical Trials *Drug Approval Human HIV Infections/DRUG THERAPY HIV Protease Inhibitors/THERAPEUTIC USE United States United States Food and Drug Administration NEWSLETTER ARTICLE

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