Source: Orange County Register (CA) Contact: http://www.ocregister.com/ Copyright: 1998 The Orange County Register Pubdate: Thur, 03 Dec 1998 Author: Denise Grady-The New York Times NADER GROUP ACCUSES FDA OF APPROVING TOO QUICKLY Health: The allegations are based on anonymous responses from doctors within the agency. Releasing its own survey of doctors who work for the Food and Drug Administration, an advocacy group accused the agency Wednesday of lowering its standards for safety and efficacy, working too hastily and approving drugs that should never have been allowed on the market. The report has drawn a scathing rebuttal from the drug industry, an oblique defense from the agency and criticism from representatives of chronically ill people who advocate swifter drug approval. But some scientists said the report raised significant concerns. The survey, announced at a news conference, was conducted by the Public Citizen's Health Research Group of Washington, which was founded by consumer advocate Ralph Nader in 1971. The organization has criticized the pharmaceutical industry and the drug-approval process, which Congress accelerated in 1992 and 1997. The people surveyed were medical officers, agency employees assigned to oversee individual drugs being evaluated for approval. The survey was anonymous and completed by 53 of the 172 people solicited. Among its findings were these: Nineteen medical officers identified 27 new drugs that were approved even though the officers thought they should not be. Seventeen said the food-and-drug agency's safety and efficacy standards have been lowered. A majority of the medical officers did not answer the survey, and a majority of those who did answer did not complain, making it impossible to tell whether the survey found genuine problems or merely provided malcontents an outlet for gripes. - --- Checked-by: Don Beck