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:
Wednesday, 9 November
Welcome and Administrative Announcements
Leslie Kux, Associate Commissioner for Policy
Dr. Robert Califf, Commissioner
- Mr. Jeffrey Francer, 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, Ropes & Gray LLP
- Ms. Coleen Klasmeier, Sidley Austin LLP
- Mr. James Czaban, DLA Piper LLP (US)
- Mr. Daniel Biank, DuVal & Associates, P.A.
- Ms. Sandra Kalter, Medtronic PLC
- Ms. Esther Carbon, RTI Surgical, 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
- Ms. Susan Cantrell, Academy of Managed Care Pharmacy
- Dr. Vikas Saini, The Lown Institute
- Mrs. Suzanne Robotti, MedShadow
- Mr. John Mack, Pharma Marketing News