FDA at a Crossroads
A conference co-sponsored by the George Washington University School of Public Health and Health Services and the Union of Concerned Scientists
As Congress prepares to debate and reauthorize the laws that govern how drugs and medical devices are evaluated, the Food and Drug Administration (FDA) stands at a crossroads. The decisions of Congress regarding the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) will affect the agency's ability to address existing and emerging challenges such as new medical technology, prescription drug and device efficacy and safety concerns, and budget limitations.
This was the context in which UCS and George Washington University co-sponsored a November 2011 conference for experts from academia, government, patient and consumer groups, and industry to exchange ideas and develop recommendations for the FDA to address these challenges. FDA officials, consumer and patient advocates, physicians, and leading academics discussed potential reforms and the best way for the agency to use independent science in drug and medical device approval and monitoring.
Margaret Hamburg, M.D., Commissioner, Food and Drug Administration
- 9:30 AM
Panel 1: Patient Safety
Moderator: Tom Burton, J.D., The Wall Street Journal
- How can the FDA better monitor clinical trials and approved drugs and improve the process for predicting drug and device safety?
- 11:00 AM
Panel 2: The Efficacy of Drugs and Devices Regulated by the FDA
Moderator: John Powers, M.D., George Washington University School of Medicine
- How can evidence-based medicine, meta-analysis, comparative effectiveness, and off-label use policies be improved and effectively implemented?
- 1:15 PM
Drug Marketing in the Digital Era and New Public Health Risks
Jeff Chester, MSW, Center for Digital Democracy
- 2:00 PM
Panel 3: Scientific Integrity at the FDA
Moderator: Francesca Grifo, Ph.D., Union of Concerned Scientists
- How can the FDA better promote a culture of transparency and scientific integrity, protect the rights of scientists and whistleblowers, and limit political and corporate interference in agency policy decisions?
- 3:15 PM
Panel 4: Institutional Challenges at the FDA
Moderator: Susan Wood, Ph.D., George Washington School of Public Health and Health Services
- How do conflicts of interest impact the work of agency advisory committees? How can the agency best allocate limited resources? Are current policies regarding user fees effective?