FDA: Transparency Taskforce — Industry + Anti Industry (No middle ground)

This past week the FDA held their first Transparency Taskforce meeting headed up by Deputy FDA Commissioner Joshua Sharfstein.  The interesting thing about the meeting is those that presented were either industry groups or anti-industry, but little representation from the middle.

This is not surprising given that Sharfstein’s early carrier included stents with Congressman Henry Waxman (D-CA) and the Ralph Nader Group (Public Citizen's Health Watch).

Industry groups included AdvaMed, PhRMA, Natural Products Association, Device Manufactures Association, Biotechnology Industry Association.  

Anti Industry groups include: Consumers Union, Pew Prescription Project,  Natural  Resources Defense Council, Public Citizen, The Senior Citizens League, and Center for Science in the Public Interest.

It is disappointing for the low representation from researchers, educators, and real patient organizations.  But this is largely because the groups speaking sent in the longest comments.  Everyone agreed that the FDA needs more transparency, it is all in how you define that transparency.

To link to any of the presentations:

Welcome and Introductory Comments
Joshua Sharfstein, MD, Principal Deputy Commissioner
Afia Asamoah, JD, MPP, Special Assistant to Principal Deputy Commissioner

Panel 1
Janet Trunzo, AdvaMed
David Lim, Independent Consultant

Panel 2
Jeffrey Francer, PhRMA
Kristi Zonno, MS, CGC, Genetic Alliance

Panel 3
Steven Findlay, Consumers Union
Bray Patrick-Lake, Consumer
Allan Coukell, Pew Prescription Project

Panel 4
Daniel Fabricant, Ph.D, Natural Products Association
Sarah Janssen, MD, Ph.D, Natural Resources Defense Council
Kathy Means, Produce Marketing Association

Panel 5
Bob Kelser, IDSN, Inc.
Kathryn Foxhall, Freelance Reporter

Panel 6
Shannon Benton, The Senior Citizens League
Peter Lurie, MD, MPH, Public Citizen
Diana Zuckerman, Ph.D., Nat’l Research Center for Women & Families

Panel 7
Mark B. Leahey, Medical Device Manufacturers Association
Nancy Beck, Ph.D.Physicians Committee for Responsible Medicine
Sin Hang Lee, MD, Milford Medical Laboratory

Panel 8
Emily Claire Napalo, Breast Cancer Fund
William H. Maisel, MD, MPH, Medical Device Safety Institute
Andrew Emmett, Biotechnology Industry Organization (BIO)

Panel 9
Sarah Klein, The Center for Science in the Public Interest
Kiyo Oden, The Tatia Oden French Memorial Foundation
Carolyn Brubaker, Microsoft

Open Comment Session

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