Drug Safety System Needs Overhaul, Experts Say

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The system for establishing and monitoring the safety of new drugs is starting to show its age and will need substantial retooling if it is to better weed out problems before or soon after drugs hit the market, stakeholders told an Institute of Medicine panel.

At the request of the U.S. Food and Drug Administration, IOM formed an ad hoc committee to assess the current system for evaluating and ensuring drug safety after approval and make recommendations to improve risk assessment, surveillance, and the safe use of drugs. In January, the committee held the fourth of a year-long series of meetings, which will culminate in a report scheduled to be released in July.

The FDA request came in response to recent public concerns raised by the high-profile case of COX-2 inhibitor Vioxx (rofecoxib), which was voluntarily removed from the market by its maker Merck & Co., in Whitehouse Station, N.J. A postmarketing cancer prevention study found that use of the drug was associated with cardiovascular problems, but by the time it was pulled from the shelves, 84 million prescriptions for the painkiller had already been written.