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Session 1: Inside the Agencies: Perspectives on Promotion, Compliance, and Consumer Protection
Session Chair(s)
Twyla Mosey, PHARMD
Acting Office Director, OPDP, CDER
FDA, United States
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
This session will feature the National Advertising Division (NAD) of BBB National Programs sharing insights into current self-regulatory priorities, competitor challenges, and standards affecting prescription drug promotion and advertising. Speakers will discuss how NAD’s self-regulatory program evaluates claim substantiation, promotes consumer trust, and encourages industry accountability in an increasingly complex and scrutinized marketplace. The discussion will also address how 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 regulatory and self-regulatory scrutiny and strengthen internal review and risk management processes.
Inside NAD: Perspectives from a Self-Regulatory Program
Phyllis Marcus, BBB National Programs
Learning Objective : - Identify three emerging priorities discussed by the NAD, and summarize their impact on prescription drug advertising and promotion practices
- Compare the differing approaches and areas of overlap among agencies
- Evaluate how inter-organizational coordination influences enforcement outcomes and apply this understanding to refine risk assessment and escalation processes within attendees’ organizations
Speaker(s)
Inside NAD: Perspectives from a Self-Regulatory Program
Phyllis Marcus, JD
BBB National Programs, United States
Vice President, National Advertising Division
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