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The Search for Safe Drugs: How Personalized Medicine Can Build a 21st Century FDA

Thursday March 2005

Panelists: Robert Goldberg, Ph..D., Moderator and Director, Center for Medical Progress at the Manhattan Institute; Robert McBurney, Ph.D., Senior Vice President, Research and Development, BG Medicine, Inc.; Gualberto Ruano, M.D., Ph.D., Chief Executive Officer, Genomas, Board of Directors, Personalized Medicine Coalition; Michael Weber, M.D., Associate Dean for Research, Downstate Medical Center, State University of New York
Indtroductory Remarks: Hon. Mike Ferguson (R-NJ), House Energy and Commerce Committee

FDA scientist David Graham has argued that “the FDA, as currently configured, is incapable of protecting America against another Vioxx.” In response, some FDA critics have called for larger and longer clinical trials before new drugs are approved, and for dozens of other drugs to be removed from the market because of rare adverse events.

But is increasing the number of lengthy, expensive, and cumbersome clinical trials really the solution for improved drug safety? Doesn’t the withdrawal of otherwise safe and effective medicines from millions of patients carry with it its own risks? Is the FDA using the best available science to identify potential safety problems and monitor the use of new medicines?

We hoped you enjoyed the discussion of the causes of the current drug safety “crisis” and examine how new, science-based approaches at the FDA, based on breakthroughs in genetic medicine and real world clinical experience, can revolutionize how the FDA promotes drug safety and encourages the development of powerful new personalized medicines for cancer, AIDS, heart disease and Alzheimer’s.