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Policy

FDA Criticized On Drug Safety Monitoring

Government Accountability Office says FDA's system for tracking drugs is 'broken'

by Bette Hileman
April 26, 2006 | A version of this story appeared in Volume 84, Issue 18

"FDA lacks clear and effective processes for making decisions about and providing management oversight of" the safety of approved prescription drugs, states a report from the Government Accountability Office.

Two FDA offices, the Office of Drug Safety and the Office of New Drugs, are involved in tracking the safety of drugs after they are on the market. ODS, however, lacks independent decision-making responsibility. It cannot pull drugs from the market or ask manufacturers to put warnings on drug labels. It acts primarily as a consultant to OND. ??Often, ODS personnel are not even invited to testify at FDA's advisory committee hearings at which safety issues are being discussed, the report says, and their recommendations are sometimes ignored.

In addition, certain data constraints impede FDA's ability to evaluate the safety of drugs after they are approved, GAO says. Two-thirds of the postmarket safety studies that the agency asks drugmakers to conduct are never even started. The Drug Safety Oversight Board, which FDA established last year, may help provide oversight of safety issues, but it will not address the lack of systematic tracking of safety issues, the report says.

GAO recommends that Congress give FDA more authority to require drugmakers to conduct postmarket studies. It also says FDA should establish a mechanism to systematically track safety issues of approved drugs. Currently, FDA's budget to conduct its own studies of drug safety is only about $1 million.

The GAO report "provides solid evidence that everything is not all right at the FDA and calls for long-overdue reform," says Sen. Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee. He and Sen. Christopher J. Dodd (D-Conn.) have introduced legislation that would empower agency scientists to conduct independent postmarket reviews of drugs.

However, Rep. Joe Barton (R-Texas), chair of the Energy & Commerce Committee, has a different view. He concludes that the report "shows that the drug safety system is not in crisis" but "may need some fine-tuning."

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