I will be Speaking at FDA’s Part 15 hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” on 9 November, 2016 (read “FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion“).

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