The purpose of this meeting is to obtain "input on issues" related to off-label product communications about by pharmaceutical and medical device companies (see here). I will presenting the preliminary results of my Direct-to-Consumer Off-Label Promotion Survey in my allotted time of 8 minutes.
Here's the list of speakers (updated 31 Oct 2016):
Wednesday, 9 November
Welcome and Administrative Announcements
Leslie Kux, Associate Commissioner for Policy
Opening Remarks
Dr. Robert Califf, Commissioner
- Mr. Michael Labson, Covington & Burling LLP, on behalf of Pharmaceutical Research and Manufacturers of America (PhRMA)
- Ms. E. Cartier Esham, Biotechnology Innovation Organization (BIO)
- Ms. Khatereh Calleja, Advanced Medical Technology Association (AdvaMed)
- Ms. Kellie Combs and Ms. Coleen Klasmeier, Medical Information Working Group (MIWG)
- Mr. James Czaban, DLA Piper LLP (US)
- Mr. Daniel Biank, DuVal & Associates, P.A.
- Ms. Sandra Kalter, Medtronic PLC
- Dr. Andrew Koenig, Pfizer Inc.
- Ms. Danelle Miller,Roche Diagnostics
- Dr. Sandra Milligan, Merck
- Mrs. Penny Levin, Teva Pharmaceuticals
- Dr. Edith Perez, Genentech
- Mr. Frank Wilton, American Association of Tissue Banks (AATB)
- Mr. Nicodemo Fiorentino, G&M Health, LLC
- Ms. Zoe Dunn, Hale Advisors
- Ms. Tracy Rockney, OneSource Regulatory
- Dr. Samuel Nussbaum, Anthem, Inc.
- Mr. Michael Hoak, Humana
- Ms. Jennifer Graff, National Pharmaceutical Council
- Dr. Soumi Saha, Academy of Managed Care Pharmacy
- Dr. Vikas Saini, The Lown Institute
- Mr. John Mack, Pharma Marketing News
- Dr. John Kamp, Coalition for Healthcare Communication
- Mr. Gregory Herbers, Washington Legal Foundation
- Mr. Ralph Hall, University of Minnesota Law School and Leavitt Partners
- Dr. William Welch, American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS)
- Mr. Jeremy Lew, Individual Stakeholder
- Ms. Sandra Raymond, Lupus Foundation of America
- Mr. Stephen Marmaras, Global Healthy Living Foundation
- Mr. Paul Melmeyer, National Organization for Rare Disorders
- Dr. Aaron Kesselheim, Brigham and Women's Hospital and Harvard Medical School
- Dr. Sidney Wolfe, Public Citizen's Health Research Group
- Dr. Michael Carome, Public Citizen’s Health Research Group
- Mr. Robert Weissman, Public Citizen
- Dr. Doris Peter, Consumer Reports
Day one closing remarks
Leslie Kux
Thursday, 10 November
Opening Remarks Leslie Kux
- Dr. Joshua M. Sharfstein, Johns Hopkins Bloomberg School of Public Health
- Mr. Steve Francesco, Do No Harm Network
- Ms. Kim Witczak, Woodymatters
- Ms. Robyn Edwards and Ms. Veverly Edwards, Consumers Union Safe Patient Project
- Ms. Lisa Gill, Consumer Reports
- Dr. Yanling Yu, Washington Advocates for Patient Safety
- Dr. Stephanie Fox-Rawlings, Patient, Consumer, and Public Health Coalition
- Ms. Dr. Diana Zuckerman, National Center for Health Research
- Ms. Melayna Lokosky, Individual Stakeholder
- Dr. Margaret McCarthy, Yale Law School
- Ms. Jeanie Kim, Yale Law School
- Ms. Amy Kapczynski, Yale Law School
- Dr. Lisa Schwartz and Dr. Steve Woloshin, The Dartmouth Institute for Health Policy and Clinical Practice
- Ms. Joy Eckert, George Washington University
- Ms. Kimberly A. Dougherty and Ms. Cara Jones, Janet, Jenner & Suggs LLC
- Dr. Adriane Fugh-Berman, Georgetown University Medical Center
- Ms. Alycia Hogenmiller, Georgetown University Medical Center
- Dr. Rebecca Jones, Individual Stakeholder
- Dr. Doyle Stulting, American Society of Cataract and Refractive Surgery (ASCRS)
- Mrs. Katherine McGahey and Ms. Lauren Brown, 1 Million 4 Anna Foundation
- Mrs. Sarah Christopherson and Ms. Christina Cherel, National Women’s Health Network
- Ms. Amy Leitman, NTM Info & Research
- Dr. Adelaide Robb, Children’s National
- Mr. Andrew Sperling, National Alliance on Mental Illness
- TBD, USA Patient Network
- Dr. Megan Coder, Pharmaceutical Care Management Association (PCMA)
- Mrs. Brigett Whitted, Individual Stakeholder
- Mr. Mychal Wilson, Whistleblower Attorney
- OPEN PUBLIC COMMENTS: Multiple 3-minute speaker slots will be available on a first-come, first-served basis.
Closing Remarks
Leslie Kux
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