Trending publication

Jonathan L. Kotlier, chair of the Government Investigations and White Collar Defense practice group, co-authored a chapter in The Food and Drug Law Institute’s (FDLI) book entitled Off-Label Communications: A Guide to Sales and Marketing Compliance, Fourth Edition, (Mark Carlisle Levy ed. 2014). The book provides practical advice on how to comply with the constantly changing world of off-label regulation, litigation and policy. Jonathan’s chapter “Off-Label Promotion: Government Theories of Prosecution and Facts That Drive Them” focuses on how the scientific exchange of information and off-label promotion are treated under FDA regulations and the FDCA, with attention to the role of the FCA. The chapter also reviews recent criminal cases and how they were resolved, in order to gain insight into where the law on off-label communications may be headed.