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Institute of Medicine report urges major changes at Food and Drug Administration

Postmarketing surveillance and increased funding are among the recommendations.

By Susan J. Landers, amednews staff. Oct. 16, 2006.

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Washington -- Restoring confidence in the nation's prescription drug monitoring system is the intention of a new Institute of Medicine report that provides a broad range of recommendations for changes at the Food and Drug Administration.

"The Future of Drug Safety: Promoting and Protecting the Health of the Public," was released Sept. 22 and advises expanding the FDA's authority to require postmarketing surveillance of approved drugs, ensuring better communication between the agency and the public on safety issues, strengthening agency leadership and boosting funding. Many of the recommendations would require legislation to put them into action.

The FDA's reputation as an effective drug safety watchdog already was under a cloud when, in 2004, it fell even more sharply after the painkiller Vioxx (rofecoxib) was withdrawn from the market. The agency took another hit that year when possible links were discovered between adolescent suicides and certain antidepressants. The IOM report was commissioned by the FDA and several other federal agencies to help resolve such situations, which often result in numerous phone calls to physicians' offices from patients concerned about the safety of their medications.

"If all the recommendations are adopted, it is possible we could see some real forward movement in a way that benefits the agency, the public and physicians who count on the FDA to do its job," said Susan Wood, PhD, who resigned from her post as director of the FDA's Office of Women's Health last year, citing concerns about agency integrity.