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Session 1: Policy and Medicine
Session Chair(s)
Kevin Appareti
Senior Director, Global Medical Science Liaison
Royal Philips, United States
Julia Petses, PharmD
Global Head, Medical Information Excellence and SEC Established and Rare Franchi
Novartis, United States
The rapid transformation of the US health care landscape creates an environment that is complex and constantly evolving. The regulation of communication is in a state of flux; the amount of activity in this area is greater today than it has been over the past several decades. It is essential under these circumstances to stay abreast of legislative, judicial, and regulatory developments that may impact how pharmaceutical companies communicate and disseminate off-label medical information. This session will provide an update of current legislative, judicial, and regulatory developments and the potential implications to our work. Topics such as: 21st Century Cures Act and companion bills, MIWG and PhRMA citizen petitions, Amarin and similar cases, and/or other relevant subjects at the time of the meeting, may be included in this session.
Learning Objective : - Describe and discuss current policy regulating communications
- Explore the trends and directions of these and other activities in order to better prepare and react to changes as they evolve
Speaker(s)
Industry Perspective
Jamie Haney, JD
Eli Lilly and Company, United States
General Cousel - Lilly Diabetes Senior Director and Assistant General Counsel
What Patient Groups and PhRMA Are Saying About Expanded Off-Label Communication
John Kamp
Coalition For Healthcare Communication (CHC), United States
Washington Counsel
The Ability to Communicate Truthful, Non-Misleading Speech: Developments in the Courts, Congress, and the Agency
Alan R Bennett, JD
Ropes & Gray, United States
Senior Counsel
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