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FDA wants drug safety 'report cards'

WASHINGTON -- 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 yesterday in response to a recent report by a committee 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.

Their release comes just days before senators Edward Kennedy, Democrat of Massachusetts, and Mike Enzi, a Wyoming Republican, 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 the 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 the agency's drug chief, Dr. Steven Galson.

The agency also said it would regularly publish newsletters to summarize its safety reviews of older drugs and disclose emerging issues.

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