The Future of Government Regulation, Enforcement of Off-Label Promotion

Source: Skadden, Arps, Slate, Meagher & Flom LLP

As an industry, we function in a highly regulated and scrutinized environment. Medical Affairs professionals in particular walk a fine line between on- and off-label promotion when discussing clinically relevant information with health care practitioners. Over the past 5 years, we have seen 4 instances where companies have not been penalized for communicating off-label information that was deemed to be “truthful and not misleading.” Three of these cases—commonly referred to as Caronia, Amarin, and Pacira—are reviewed in this article by Skadden, Arps, Slate, Meagher & Flom LLP. To download this article, please visit [insert link to MAPS website]. This article by Skadden et al is made available with permission from Skadden, Arps, Slate, Meagher & Flom LLP. Please note that this article is for informational purposes only and is not intended to provide legal advice.

Information on the 4th case, Vascular Solutions, can be found using the link below:[mepr-show if=”rule: 4078″]


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