The US Food and Drug Administration, or FDA, faces a torrent of scrutiny these days, with high-profile drug safety problems raising questions about its ability to act as the public's medical watchdog.

Some of the harshest criticism has come from a whistleblower in the FDA's own ranks: drug safety reviewer David J. Graham, M.D., MPH. At Congressional hearings last fall, Graham testified that not only did the pain-reliever Vioxx pose risks, but that he was concerned about the safety of several other drugs already on the market with FDA approval.

On Friday, May 6, Graham will speak about these concerns, and the FDA's role in protecting patients from harm, as part of a symposium sponsored by the U-M Medical School's Forum on Health Policy. The symposium is titled "The FDA's Role in Improving Patient Safety."

The two-hour event will begin at noon in the Ford Amphitheater in University Hospital on E. Medical Center Drive, Ann Arbor. It is free and open to the public; for more information call 734-615-8334 or e-mail gkasmerumich.edu.

Graham will be speaking as an individual, not in his official capacity, and consequently the views expressed may not reflect those of the FDA.

His talk will be followed by discussion and questions from a panel composed of experts from several fields:

-- Industry: Mark Horn, M.D., MPH, medical director, Government Relations Group, Pfizer, Inc.

-- Media: Matthew Herper, Forbes magazine, who profiled Graham as the magazine's "Face of the Year"

-- Academia: Daniel Carpenter, Ph.D., professor of government, Harvard University, who has studied the FDA's regulatory role for years and is currently completing a book on the agency

-- Consumers: N. Lee Rucker, M.S.P.H., Senior Policy Advisor, AARP Public Policy Institute

The panel will be moderated by Duane Kirking, Pharm.D., Ph.D., professor and former chair of Social and Administrative Sciences in the U-M College of Pharmacy. Members of the audience will be able to address questions to Graham and to panel members.

Graham and other FDA critics aired their criticisms of the agency in the wake of the voluntary withdrawal of Vioxx last September 30. In Congressional hearings in November, Graham testified that he felt that another drug in the same class as Vioxx, the Pfizer product Bextra, was also unsafe. On April 5, Pfizer withdrew Bextra from the market upon FDA request, and agreed to add a warning to the label of a similar drug, Celebrex.

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View drug information on Bextra; Vioxx.