As part of our “Throwback Thursday” blog series, we’re taking a look at a topic that’s currently in the news and tagging it with previous research, videos or commentaries in a relevant way. As the saying goes, “what’s old is new again” – and we hope you enjoy our wonky twist on #TBT.
Last week the U.S. District Court for the Southern District of New York ruled in a preliminary order that Amarin Pharmaceuticals may engage in truthful and non-misleading speech regarding an unapproved use of its prescription fish oil pill, Vascepa. While it’s clearly a significant decision, it remains to be seen whether the case will be applied narrowly in a way that could limit its applicability to other biopharmaceutical communications.
To be clear, the ruling in this case refers to communications with physicians, while the National Pharmaceutical Council (NPC) has undertaken peer-reviewed studies related to the exchange of information with payers to assist in making coverage decisions. However, U.S. v. Caronia, the 2012 First Amendment case that was used as the basis for the Amarin decision, potentially has implications in either communications situation.
During the last few years, NPC has spoken with numerous stakeholders about the asymmetries, or inequalities, in how the biopharmaceutical industry can communicate health information to other health care stakeholders, as well as the Caronia case. In a video interview—and our #TBT pick of the week—Alan Bennett, managing partner at Ropes & Gray, discussed Caronia, which was still being considered during the time of the interview, and explained what the ruling could mean for biopharmaceutical communications.
Mr. Bennett’s interview is part of NPC’s video playlist featuring experts highlighting various aspects of this topic, such as an ethical framework for considering challenges in comparative effectiveness research (CER) communications; patient and other stakeholder information needs; CER, the Food and Drug Administration and the First Amendment challenge; and ensuring access to information.
For further information about this topic, check out NPC’s other resources:
- When Does FDAMA Section 114 Apply? Ten Case Studies, Value in Health (April 2015)
- Health Affairs cluster of articles on communicating CER
- NPC conference, Asymmetry in the Ability to Communication CER Findings
- Chapter on Comparative Effectiveness Research and Communications in the Food & Drug Law Institute’s book, Off-Label Communications: A Guide to Sales & Marketing Compliance