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Session 1: Inside the Agencies: Perspectives on Promotion, Compliance, and Consumer Protection
Session Chair(s)
Twyla Mosey, PharmD, RPh
Division Director
FDA, United States
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
This session will share insights into current priorities, enforcement trends, and evolving standards impacting prescription drug promotion and advertising. Speakers will highlight how each organization approaches claim substantiation, consumer protection, and industry accountability within an increasingly scrutinized marketplace. The discussion will also address how FTC and NAD activities intersect with FDA-regulated promotion and what companies can do to align their compliance and advertising practices accordingly. Attendees will gain actionable strategies to anticipate enforcement focus areas and strengthen internal review and risk management processes.
Learning Objective : - Identify three emerging regulatory or enforcement priorities discussed by various agencies, and summarize their impact on prescription drug advertising and promotion practices
- Compare the differing approaches and areas of overlap among the four agencies
- Evaluate how interagency coordination influences enforcement outcomes and apply this understanding to refine risk assessment and escalation processes within attendees’ organizations
Speaker(s)
Speaker
Phyllis Marcus
BBB National Programs, United States
Vice President, National Advertising Division
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