"Petition Seeks to Speed Approval of AIDS Drugs"

Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.

"Petition Seeks to Speed Approval of AIDS Drugs"

New York Times (12/21/90), P. A31
Kolata, Gina

Abstract: AIDS activists have tried a new tactic to speed approval of experimental drugs: about 200 doctors and advocates have signed a citizen's petition urging the Food and Drug Administration (FDA) to ask the drug makers of ddI and ddC to send in their data for approval. The petition, believed to be the first to try forcing the FDA to quickly approve rather than remove drugs from the market, will be submitted to the agency today if the activists can reach a consensus. The petition seeks speedy review of ddI and ddC using clinical markers to define efficacy. The idea for the move came from Dr. Sidney Wolfe, director of the consumer advocacy group Public Citizen. AIDS activists formerly thought Wolfe opposed their cause because of his history of asking for stricter regulation and trying to remove drugs from the market. Activists can sue if the FDA does not comply with the petition, and experts say precedent and the FDA's own regulations back the activists' demands.

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