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Medical Progress and the FDA: Our Future in the Balance

Monday June 2002

Moderator: Robert Goldberg, Ph.D., Senior Fellow, Manhattan Institute, Director, Center for Medical Progress Welcome: Alan Slobodin, Counsel, House Energy & Commerce Committee; Panelists: Joseph Calfee, Ph.D., Senior Fellow, American Enterprise Institute; Joseph DiMasi, Ph.D., Director of Economic Analysis, Tufts University Center for the Study of Drug Development; Robert Oldham, MD, President, South Carolina Biotechnology Association

Is the Food and Drug Administration up to the task of providing consumers timely access to the next generation of medical breakthroughs? Despite reforms designed to speed up drug and device approval and provide the public with more information about new technology, the FDA’s regulatory process is associated with increasing drug development costs, shifting standards of safety and effectiveness and an inability to keep pace with changes in the way drugs are discovered, developed and used. What is the state of medical progress in the context of FDA regulation and what can be done to improve the pace of medical innovation given the agency’s mission to promote and protect the public’s health? This forum, with some the nation’s leading experts on the FDA, will answer these important questions as the Congress takes up FDA reform this session.