What to Know and Do as FDA Advertising Scrutiny Increases for Life Sciences

FDA Advertising Scrutiny title slide
What to Know and Do as FDA Advertising Scrutiny Increases for Life Sciences
November 20, 2025

In September 2025, the U.S. FDA launched a major enforcement campaign targeting direct-to-consumer (DTC) pharmaceutical advertising that misleads patients or downplays risks. Following a September 2025 presidential directive, the agency announced hundreds of enforcement actions—including over 100 cease-and-desist letters—signaling a zero-tolerance stance toward unbalanced or deceptive ads. While most of the letters focused on DTC content, FDA also sent letters for health care provider (HCP) promotion. The message: Government scrutiny and enforcement will significantly increase for biopharma as well as medical device promotion. This webinar includes regulatory compliance and drug advertising compliance experts who dissect the FDA’s mindset and ways to proactively mitigate concerns.

In this webinar, panelists:
– Drill down into FDA’s renewed enforcement areas
– Dissect the implications of increased enforcement on the industry
– Identify specific cases that are clear examples for company concern
– Isolate the key principles for avoiding violations and demonstrating good faith

Webinar Slides for What to Know and Do as FDA Advertising Scrutiny Increases
Moderators & Speakers
Ilyssa Levins-Pimienta
Ilyssa Levins-Pimienta, Moderator
CEO
SecureCHEK AI, and Founder, Center for Communication Compliance (CCC)
Robert Dean headshot
Robert Dean
Head of Global Labeling Strategy & Ad/Promo
EMD Serono, Inc.
Howard Dorfman
Howard Dorfman
Founder
H.L. Dorfman Pharmaceutical Consulting, LLC