Watchdog group releases study criticizing FDA approval processDecember 2, 1998
Web posted at: 5:18 p.m. EDT (2118 GMT)
WASHINGTON (CNN)-- Some medical officers in the Food and Drug Administration believe there has been a "lowering" of FDA safety and efficacy standards for new drug approvals, according to a report released Wednesday by Public Citizen.
The watchdog group commissioned and funded the report. It claims the many substandard drugs were approved when they perhaps should not have been.
The study, "FDA Medical Officers Report Lower Standards Permit Dangerous Drug Approval," surveyed 53 out of the 172 FDA medical officers, physicians who examine the data on new drug applications and make decisions whether or not to recommend a drug for approval.
According to the findings, during the past three years the FDA medical officers identified 27 new drugs that they believe should never have received official approval.
Seventeen of the officers thought the FDA safety and efficacy standards are "lower" or "much lower" compared to the standards prior to 1995.
Other study findings include:
A statement released by Dr. Janet Woodcock, FDA Director of the Center for Drug Evaluation and Research, stated the agency continues to maintain "the highest standards in the world for approving drugs."
Woodcock said "unless a new drug's demonstrated benefit outweighs its risk for an intended population, the drug is not approved."
Dr. Sidney Wolfe, director of Public Citizen, suggested the study findings "raise a red flag" and illustrate the FDA is on a "perilous course" if it continues to ignore the advice of its own medical officers and information which raises concerns about the safety and effectiveness of new drugs.
He said the FDA will only ban a drug "after enough people are injured or killed."
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