This On Demand Recording was recorded live during the Medical Affairs and Scientific Communications Annual Forum. 

Subsequently there may be short periods of time where the sound level may vary for any given presentation.  During these short intervals, you may want to turn up the speaker volume on your computer.

This session was chaired by Kevin Appareti and Julia Petses.

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.

Session Talks Include:

• What Patient Groups and PhRMA are Saying About Expanded Off-label Communication - John Kamp
• The Ability to Communicate Truthful, Non-Misleading Speech: Developments in the Courts, Congress, and the Agency - Alan R. Bennett
• Industry Perspective - Jamie E. Haney