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U.S. Department of Health and Human Services

For Industry

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Agenda, Prescription Drug User Fee Act (PDUFA) Public Meeting November 14, 2005

9:00 a.m.

Welcome -- Deborah Henderson, Moderator

 

9:10 a.m.

Opening Remarks -- Andrew von Eschenbach, M.D.

 

9:20 - 10:00 a.m.

Panel I -- Presentations by FDA

  • Scott Gottlieb, M.D.
    Deputy Commissioner for Policy, FDA
  • Janet Woodcock, M.D.
    Deputy Commissioner of Operations and Chief Operating Officer, FDA
  • Steven Galson, M.D., M.P.H.
    Director, Center for Drug Evaluation and Research, FDA
  • Jesse Goodman, M.D.
    Director, Center for Biologics Evaluation and Research, FDA
10:00 - 10:50 a.m.

Panel II -- Presentations by Academic Research Groups

  • Kenneth Kaitin, Ph.D.
    Director, Tufts Center for the Study of Drug Development
  • Raymond L. Woosley, M.D., Ph.D.
    President, CEO, The Critical Path Institute, University of Arizona
  • Ernst R. Berndt, Ph.D.
    Louis B. Seley Professor of Applied Economics at the MIT Sloan School of Management and Director of the national Bureau of Economic research Program on Technical Progress and Productivity Measurement
  • Hugh Tilson, M.D.
    Chair, National Steering Committee, Centers for Education and Research on Therapeutics (CERTs)
10:50 - 11:00 a.m Break
11:00 - 11:50 a.m.

Panel III -- Presentations by Patient Advocacy Groups

  • Perry Cohen, Ph.D.
    Project Director, Parkinson Pipeline Project
  • Diane Dorman
    Vice President, National Organization for Rare Disorders (NORD)
  • Ellen V. Sigal, Ph.D.
    Chairperson, Friends of Cancer Research
  • Jeanne Ireland
    Director of Public Policy, Elizabeth Glaser Pediatric AIDS Foundation
11:50 - 1:00 p.m Lunch
1:00 - 1:50 p.m.

Panel IV -- Presentations by Consumer Groups

  • William Vaughan
    Senior Policy Analyst, Consumers Union
  • Alison Rein, M.S.
    Assistant Director for Food and Health Policy,National Consumers League
  • Arthur Levin, M.P.H.
    Director, Center for Medical Consumers
  • Diana Zuckerman, Ph.D
    President, National Research Center for Women and Families
1:50 - 2:30 p.m

Panel V - Presentations by Industry Groups

  • Alison Lawton
    Managing Director for Science and Regulatory Affairs, Biotechnology Industry Organization (BIO)
  • Bruce Burlington, M.D.
    Executive Vice President Regulatory Affairs and Compliance, Wyeth/Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Mary Gustafson, M.P.H.
    Sr. Director, Global Regulatory Policy
    Plasma Protein Therapeutics Association
2:30 - 2:45 p.m. Break
1:45 - 3:50 p.m.

Panel VI - Presentations by Health Professional Groups

  • Carole Redding Flamm, M.D., M.P.H.
    Senior Medical Director, Office of Clinical Affairs, Blue Cross/Blue Shield Association
  • Judith A. Cahill
    Executive Director, Academy of Managed Care Pharmacy
  • Susan Winckler, RPh., Esq.
    Vice President for Policy and Communication and Staff Counsel for American Pharmaceutical Association
  • Allen Vaida, Pharm.D.
    Executive Director, Institute for Safe Medication Practices
  • William A. Zellmer, M.P.H.
    Deputy Executive Vice President, American Society of Health-System Pharmacists (ASHP)
3:50 - 5:00 p.m. Open Public Comment Period