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

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 will dissect the FDA’s mindset and ways to proactively mitigate concerns.

In this webinar, panelists will:

– 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

Moderator:

– Ilyssa Levins-Pimienta, Inventor/Founder of SecureCHEK AI and Center for Communication Compliance  

Speakers:

– Robert Dean, Head of Global Labeling Strategy & Ad/Promo, EMD Serono, Inc.

– Howard Dorfman, Founder, H.L. Dorfman Pharmaceutical Consulting, LLC

Webinar recorded on November 20, 2025 by the Biotechnology Innovation Organization (BIO).