Meet Me at FDA Public Hearing on Off-Label Promotion on November 9, 2016

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

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