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CENTER FOR MEDICAL PROGRESS BRIEFING
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BETTER AMERICAN HEALTH, MORE AMERICAN JOBS:
REAUTHORIZATION OF PDUFA AND MDUFA
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WEDNESDAY, NOVEMBER 9, 2011
10:30 AM - 2:00 PM
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RUSSELL SENATE OFFICE BUILDING
SR 385
WASHINGTON, DC
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10:30 a.m.- 12:00 p.m.
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PANEL ONE: PDUFA V: Advancing Patient-Centered Innovations
Moderator: Paul Howard, Director and Senior Fellow, Manhattan Institute's Center for Medical Progress
Janet Woodcock, Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Cynthia Bens, Director of Public Policy, Alliance for Aging Research
Andrew Emmett, Managing Director, Science and Regulatory Affairs, Biotechnology Industry Organization
Keith Flanagan, Health Counsel, Senate HELP Committee
Christopher-Paul Milne, Associate Director, Tufts Center for the Study of Drug Development, Tufts University
Avik Roy, Senior Fellow, Manhattan Institute's Center for Medical Progress
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12:00 p.m.-12:30 p.m.
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Brown bag lunch
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12:30 p.m.- 2:00 p.m.
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PANEL TWO: MDUFA and Beyond: Balancing Safety and Innovation for Medical Devices
Moderator: Susan Winckler, President & CEO, Food and Drug Law Institute
Jeffrey Shuren, Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Amy Allina, Program and Policy Director, National Women's Health Network
Michael Carome, Deputy Director, Public Citizen’s Health Research Group
Ralph Hall, Professor of Practice, University of Minnesota Law School
Abby Kral, Legislative Assistant, Office of Senator Scott Brown
Charlene MacDonald, Senior Health Care Policy Advisor, Office of Representative Allyson Schwartz
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Both the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) have worked to advance public health, safeguard patient safety, and give patients greater access to life-saving new medicines and medical devices. However, in recent years, the original successes of PDUFA/MDUFA may have slipped, partly due to additional responsibilities placed on the FDA. Both laws are critical to patients getting timely access to breakthrough medicines and technologies, and to keeping the United States the global leader in life sciences innovation.
Please join us for a discussion of the critical issues facing Congress as it prepares to reauthorize PDUFA and MDUFA in 2012. The panels will discuss:
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How the PDUFA/MDUFA frameworks are structured, and have evolved over time
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The FDA's perspective on the value and role of user fees at the agency
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Key components of the current PDUFA technical agreement with industry
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Stakeholder concerns regarding risk/benefit balancing for new products
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Opportunities for improving regulatory science and procedures for evaluating new medicines and medical devices
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