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Session 3: DTC Promotion at a Crossroads: The Evolving Landscape of Regulatory and Legal Policy
Session Chair(s)
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
Virginia Foley
Founder, CEO
Compliance Forward, United States
This session will explore the shifting legal and regulatory landscape shaping prescription drug promotion in today’s highly scrutinized environment. Experts will discuss the impacts of government priorities, evolving DOJ expectations, and recent changes in the OPDP/APLB advisory process for DTC advertising. Attendees will gain practical insights into how these developments are redefining risk, compliance, and strategy across the promotional review space.
Learning Objective : - Identify legal or regulatory developments influencing prescription drug promotion and explain their implications for promotional review practices
- Evaluate how government enforcement trends and policy changes affect DTC advertising, risk assessment, and claim substantiation strategies
- Apply insights to update or refine internal promotional review or monitoring process demonstrating measurable improvement in efficiency and regulatory alignment
Speaker(s)
Speaker
Heather Banuelos, JD
King & Spalding LLP, United States
Counsel
Speaker
Alexander Gaffney, MS, RAC
AgencyIQ by POLITICO, United States
Vice President, Regulatory Policy And Intelligence
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