Lines in the Sand: Extracting Hard Lines from Government Guidance on Social Media

March 12, 2015 10:00am

Elise Fellner Roth
Buchanan Ingersoll & Rooney PC

Christine Mikail
Senior Vice President, Legal Affairs & General Counsel
NPS Pharmaceuticals, Inc.

  • What are some of the most effective social media tools which carry the least risk
  • To Tweet or not to Tweet: Clarifications on FDA guidance and potential loopholes
  • Translating “guidance” to best practices
  • The legal ramifications for noncompliance: Does the FDA have jurisdiction over Twitter?
  • How to employ practices which ensure statements made by third parties on company sponsored sites are not perceived to be endorsed by them
    • Keeping track of internet marketing to ensure rules are not violated
    • Assigning responsibility for monitoring social media
    • Creating parameters for responding to off-label, and other inquiries in chat rooms, message boards, and other media outlets
  • Word choices that have previously triggered government scrutiny