FDA Considering Drug Report Cards

Posted on January 30, 2007

The FDA is considering issuing drug report cards that inform the public about problems with drugs and drug side effects. This would be for drugs that the FDA has already approved. MSNBC.com reports the FDA is looking for new ideas following the "public outcry over the withdrawal of the painkiller Vioxx."

As part of a pilot program, the Food and Drug Administration will issue drug "report cards" that would detail unexpected side effects that emerge only after a drug has been approved. The reports also would include follow-up studies and details about how the drugs are being used.

The proposal is one of roughly a dozen initiatives, new and ongoing, that 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.

It 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 drug report cards are something the FDA is considering but nothing has been decided. The Associated Press says the FDA did say it will "publish newsletters to summarize its safety reviews of older drugs and disclose emerging issues." You can find drug information currently on the FDA's website on this webpage. Each drug has a Drug Information Page. For example, the page for Aciphex can be found here. It includes information about the drug as well as a date indicated when the information was last updated.

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