No link between accelerated approval process and drug safety

NEWS IN BRIEF — Posted Sept. 26, 2005

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Faster approval of new drugs by the Food and Drug Administration has not increased the number of prescription drugs withdrawn for safety reasons in this country, says a recent analysis by the Tufts Center for the Study of Drug Development.

"Given rising public concern over drug safety, and assertions by FDA critics that drug safety in the United States has deteriorated since the adoption of user fees [which helped hasten drug review] in 1993, we wanted to investigate the matter," said Kenneth I. Kaitin, PhD, director of the center.

The center found that instead of more drugs being withdrawn from the market because of safety concerns, there have been fewer withdrawals since 2000. The Prescription Drug User Fee Act enabled the FDA to assess drug firms extra fees that could be used to hire more reviewers and improve the drug review process.

The center's analysis found that 3.2% of all drugs approved for sale in the United States in the 1980s were subsequently withdrawn. That rate increased slightly to 3.5% in the 1990s and since then has dropped to 1.6%.

Note: This item originally appeared at

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