戻る Agenda
AdPromo: Assessing Risk in the Current Regulatory Environment
Session Chair(s)
Mark Gaydos
Head of Labeling and Advertising & Promotion, Global Regulatory Science
Moderna, 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 : Evaluate the regulatory, legal, and compliance environment for prescription drug and medical device advertising and promotion in the context of First Amendment case law; Apply key factors to making well-informed assessments of risk and communication of impact in proposed promotion and advertising tactics and promotional material.
Speaker(s)
Panelist
Torrey Cope, JD
Sidley Austin LLP, United States
Partner
Panelist
Alan G. Minsk, JD
Arnall Golden Gregory LLP, United States
Partner, Head of Food and Drug Team