FDA at a Crossroads
November 15, 2011Download: FDA at a Crossroads Agenda
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.
The goal of the conference is to create a forum 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 will discuss potential reforms and the best way for the agency to use independent science in drug and medical device approval and monitoring.
FDA Commissioner Margaret Hamburg, M.D., is scheduled to give the keynote address. The conference will be webcast; remote viewers will have the opportunity to ask questions of the panelists.
Where: Jack Morton Auditorium , George Washington University, Washington, DC
When: November 15, 2011; 8:30am - 5:00pm, with reception to follow.
Registration: RSVP here if you plan to attend the conference.
- 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?
- 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?Last Revised: 10/12/11
Monday, November 14, 2011
Tomorrow - FDA at a Crossroads | Union of Concerned Scientists