AdPromo:Assessing Risk in the Current Regulatory Environment
VP, NA General Medicines/US Advertising and Promotion, Global Regulatory Affairs
Sanofi, United States
The interpretation and application of advertising and promotion regulations continue to evolve under 21st Century Cures, new customers and sources of data, and new FDA guidance. The dearth of enforcement letters can imply 'anything goes' but DOJ/False Claims investigations and settlements, CIAs, etc., suggest otherwise. FDA and other government enforcement trends will be discussed, including a review of cases involving whistle blowers , DOJ, False Claims Act, Lanham Act and CIAs. In this “point – counterpoint” session, attendees will be equipped with a greater understanding of the environment which will contribute to better decision making when assessing advertising and promotional activities and materials and the potential unintended implications today.
Learning Objective : Develop an understanding of the regulatory, legal, and compliance environment for prescription drug and medical device advertising and promotion in the context of First Amendment case law, a continuing decrease in FDA enforcement letters, the Lanham Act, DOJ investigations, etc; Apply key factors to making well-informed assessments of risk and communication of impact in proposed promotion and advertising tactics and promotional material.
Coleen Klasmeier, JD
Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice
Sidley Austin, LLP, United States
Alan G. Minsk, JD
Partner, Head of Food and Drug Team
Arnall Golden Gregory LLP, United States