Challenges for the FDA: The Future of Drug Safety. Workshop Summary


Note: Proceedings contain the opinion of the presenters, but do NOT reflect the conclusions of the Health and Medicine Division or the National Academies. Learn more about the differences between Reports and Proceedings.

The U.S. Food and Drug Administration (FDA) carries out one of the most critical consumer protection functions of the federal government: ensuring the safety of prescription drugs taken by millions of Americans. Since 1992, however, federal funding for the agency has diminished, and recent highly publicized events such as the recall of Vioxx have damaged public confidence in the agency. The IOM report released in September 2006, The Future of Drug Safety: Promoting and Protecting the Health of the Public, provided an independent assessment of the current U.S. drug safety system and included 25 recommendations for improving the system for drug safety review.

Like many government agencies, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM’s Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. The symposium addressed the financial implications of many of the IOM’s recommendations, including strengthening the scientific base of the agency, integrating pre- and postmarket review, enhancing postmarket safety monitoring, conducting confirmatory drug safety and efficacy studies, improving clinical trial registration, and bolstering FDA’s regulatory and enforcement authority.  The proceedings of the symposium are summarized in Challenges for the FDA: The Future of Drug Safety, Workshop Summary.