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FDA Consultation in Developing PDUFA IV Recommendations

FDA Consultation in Developing PDUFA IV Recommendations

Date
Time
Length
SubjectsParticipants
11/14/05
9:00 to 5:00 PM
8 Hours
What is your assessment of the overall performance of the PDUFA program so far and what aspects of PDUFA should be retained and what should be changed to strengthen the PDUFA program?FDA:
Andrew von Eschenbach, OC
Scott Gottlieb, OC
Janet Woodcock, OC
Steven Galson, CDER
Jesse Goodman, CBER
Deborah Henderson, CDER

ACADEMIC RESEARCH:
Kenneth Kaitin, Tufts Center for the Study of Drug Development
Raymond L. Woosley, The Critical Path Institute, University of Arizona
Ernst R. Berndt, MIT Sloan School of Management and National Bureau of Economic Research Program on Technical Progress and Productivity Measurement
High Tilson, Centers for Education and Research on Therapeutics

PATIENTS:
Perry Cohen, Parkinsons Pipeline Project
Diane Dorman, National Organization for Rare Disorders
Jeanne Ireland, Elizabeth Glaser Pediatric AIDS Foundation
Ellen Sigal, Friends of Cancer Research

CONSUMERS:

Alison Rein, National Consumers League
William Vaughan, Consumers Union
Arthur Levin, Center for Medical Consumers
Diana Zuckerman, National Research Center for Women & Families
Amy Allina, National Women's Health Network

HEALTH PROFESSIONALS:
Carole Redding Flamm, Blue Cross/Blue Shield Association
Judith Cahill, Academy of Managed Care Pharmacy
Susan Winckler, American Pharmaceutical Association
Allen Vaida, Institute for Safe Medication Practices
William Zellmer, American Society of Health-System Pharmacists

INDUSTRY:
Alison Lawton, Biotechnology Industry Organization (BIO)
Bruce Burlington, Wyeth/Pharmaceutical Research and Manufacturers of America [PhRMA]
Mary Gustafson, Plasma Protein Therapeutics Association
Alan Kirschenbaum on behalf of Council on Radionuclides and Radiopharmaceuticals
Milton Ellis, Rare Disease Therapeutics
Milt Hench, Regent Medical

OTHER:
Bill Rosen, Clinical Data Interchange Standards Consortium
5/22/06
9:00 to 11:00 AM
2 Hours
  • FDA Overview of PDUFA
  • Stakeholder Perspectives on post-market safety activities
  • Stakeholder perspectives on direct-to-consumer advertising
  • Stakeholder perspectives on meaningful measures related to improved FDA performance
  • Other issues of concern to stakeholders
Q&A Session
FDA:
Janet Woodcock, OC
Theresa Mullin, OPPL
Steven Galson, CDER
Jesse Goodman, CBER
Douglas Throckmorton, CDER
Robert Yetter, CBER
Theresa Toigo, OER
Patricia Kuntze, OER
Patricia Stewart, OPPL

PATIENTS:
Jennifer Taylor McBride, Arthritis Foundation
Perry Cohen, Parkinson Pipeline Project
Elridge Proctor, Tourette Syndrome Association
Jeff Coughlin, Jeff Allen, Friends of Cancer Research
Shawn O'Neaill, National MS Society
Kara Lee-Burton, Mark Del Monte, Suzanne Palinski, American Academy of Pediatrics
Martha Nolan, Society for Women's Health Research
Megan Moore, Diane Dorman, National Organization for Rare Disorders
Mary Richards, Parkinsons Action Network
Leslie Hanrahan, The Lupus Foundation of America
Roberta Biegel, National Osteoporosis Foundation
George Dahlman, The Leukemia & Lymphoma Society
Jayne E. Murdock, National Kidney Foundation
5/23/06
2:00 to 4:00 PM
2 Hours
  • FDA Overview of PDUFA
  • Stakeholder Perspectives on postmarket safety activities
  • Stakeholder perspectives on direct-to-consumer advertising
  • Stakeholder perspectives on meaningful measures related to improved FDA performance
  • Other issues of concern to stakeholders
Q&A Session
FDA:
Kathleen Heuer, OM
Randy Lutter, OPPL
Janet Woodcock, OC
Theresa Mullin, OPPL
Douglas Throckmorton, CDER
Robert Yetter, CBER
Patricia Kuntze, OER
Patricia Stewart, OPPL
Theresa Toigo, OER

CONSUMERS:

Lee Rucker, AARP
Arthur Levin, Center for Medical Consumers
Merrill Goozner, Center for Science in the Public Interest
William Vaughan, Consumers Union
Mark Cohen, Government Accountability Project
Alison Rein, National Consumers League
Diana Zuckerman, National Research Center for Women & Families
Lindsey Wade, National Research
Center for Women & Families
Amy Allina, National Women's Health Network
Jeff Bloom, Title II Community AIDS National Network
Paul Brown, US Public Interest Research Group
6/23/06
1:00 to 3:00 PM
2 Hours
  • FDA Overview of PDUFA
  • Stakeholder Perspectives on postmarket safety activities
  • Stakeholder perspectives on direct-to-consumer advertising
  • Stakeholder perspectives on meaningful measures related to improved FDA performance
  • Other issues of concern to stakeholders
Q&A Session
FDA:
Janet Woodcock, OC
Randall Lutter, OPPL
Theresa Mullin, OPPL
Jesse Goodman, CBER
Paul Seligman, CDER
Terry Toigo, OER
Brenda Evelyn, OER
Patricia Stewart, OPPL
Kristen Smith, OC

MEDICAL COMMUNITY:
Judith Cahill, William Hermelin, Marissa Schlaifer, Academy of Managed Care Pharmacy
Joseph Cranston, American Medical Association
Mark Del Monte, Kara Lee-Brunton, American Academy of Pediatrics
Michael Ellwood, American Academy of Physician Assistants
Pamela Ferraro, Shelagh Foster, American Society of Hematology
G. Brockwel Heylin, American Association of Clinical Endocrinologists
Angela Jeansonne, American Osteopathic Association
Neil Kirschner, American College of Physicians
Sarah Matthew, American Association of Colleges of Pharmacy
Sara Mechum, American Academy of Child & Adolescent Psychiatry
Claudia Soho, American Society of Clinical Oncology
Susan Winckler, The American Pharmacists Association
Kim Wittenberg, Association of American Medical Colleges

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