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FDA Proposes Changes to Improve Drug Safety

The plans include issuing drug safety “report cards” detailing unexpected side effects that crop up after drugs are approved for market, upgrading an electronic database that tracks reports of possible side effects, making organizational changes to improve the agency’s internal communication about potential risks, and creating an advisory panel on risk communication.

The agency’s announcement comes on the heels of a public outcry after Merck & Co.’s Vioxx painkiller was linked to elevated risks of heart attack and stroke. Merck withdrew Vioxx in 2004 after five years on the market.

A September 2006 report by the Institute of Medicine criticized the FDA’s handling of the Vioxx case, saying that “organizational problems” at the agency “may affect its ability to accomplish the mission of protecting and advancing the public’s health.”

Today, the agency said that it was going to make “specific organizational and management changes to increase communications among FDA review staff and safety staff.”

Along with the organizational changes and drug report cards, FDA also said it plans to publish regular newsletters summarizing safety reviews of older drugs and highlighting any emerging safety issues.

The agency’s announcement came as Sens. Edward Kennedy, D-Mass., and Mike Enzi, R-Wyo., prepare to introduce legislation to overhaul FDA’s drug safety program.

“Today’s report is thoughtful and provides important recommendations for administrative action, but only legislation can give FDA the tools it needs to ensure that FDA is the gold standard for safety,” Kennedy said in a statement.

University of Wisconsin bioethicist Alta Charo, a member of the Institute of Medicine committee that wrote the critical report, told Bloomberg news that the agency’s plans include many “first steps in the right direction.” However, she also said that she didn’t think they went far enough in sharing data on potential drug side effects with outside experts and the public.

“Crucial to our recommendation was that these postmarketing data be shared with an advisory committee made up of independent safety experts,” Charo told the Associated Press. “Their proposal would have the data remain internal.”

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