FDA proposes "report cards" on the safety of new drugs

The public outcry over the withdrawal of the painkiller Vioxx is leading to closer government scrutiny of new drugs to identify and disclose late-developing safety problems.

As part of a pilot program, the Food and Drug Administration will issue drug "report cards" that would detail unexpected side effects that emerge within 18 months of a drug's approval. The reports also would include follow-up studies and details about how the drugs are being used.

The proposal is among more than a dozen initiatives the FDA unveiled Tuesday in response to a recent report by a committee of experts at the Institute of Medicine that criticized the agency's handling of drug safety in the wake of the Vioxx case. Nor will it be the last word, said FDA Commissioner Dr. Andrew von Eschenbach.

"It will be a continuous process of improvement. The initiatives we are announcing today are not the full story, nor are they the final chapter in that story," von Eschenbach told reporters.

Their release comes just days before Sens. Edward Kennedy, D-Mass., and Mike Enzi, R-Wyo., introduce legislation to overhaul how the FDA handles drug safety.

"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.

The Institute of Medicine report was prompted in part by the 2004 withdrawal of Vioxx after research showed it increased risk of heart attacks and strokes. The report said the FDA needs more funding, people and authority to ensure it focuses on the safety of drugs while they remain on the market.

The FDA also hopes to step up its mining of large public and private health care databases to detect emerging safety problems, said agency drug chief Dr. Steven Galson. The Department of Veterans Affairs recently signed an agreement to share such information with the FDA.

The agency also said it would regularly publish newsletters to summarize its safety reviews of older drugs and disclose emerging issues. However, the newsletters would be scrubbed of whatever the FDA deemed confidential commercial and predecisional information, the agency said.

The Institute of Medicine, part of the federally chartered National Academy of Sciences, had pushed for even more public disclosure of that underlying information, said Alta Charo, a member of the committee that wrote the report who is also a University of Wisconsin professor of law and bioethics.

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

Both the FDA and the drug industry are concerned that broad disclosure of preliminary information about apparent safety problems could do more harm than good.

"One thing we don't want to see happen is if patients get concerned and they decide to stop therapy and don't talk to their doctors," said Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America, a drug industry group.

The FDA did not address the Institute of Medicine report's specific recommendations for Congress, including its push for additional agency funding and authority.

Without that, the FDA's proposals amount to "small potatoes," said Bill Vaughan, a senior policy analyst at Consumers Union.

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