What To Do and Not Do as Regulatory Enforcement Increases for Life Sciences
For all of us working in life sciences, the ripple effect of what happened in September with the FDA’s recent wave of enforcement activity, driven by a new HHS directive, caught the entire industry off guard.
After years of relative quiet, the agency issued a flood of Untitled and Warning Letters — signaling a return to tough, fundamentals-based enforcement. For many, it felt like déjà vu from the 1990s — only this time, applied to today’s complex digital ecosystem of social media, DTC TV, and influencer campaigns.
That’s why I can’t wait to moderate a special one-hour webinar on November 20 at 2:00 p.m. ET in partnership with BIO—the Biotechnology Innovation Organization that digs into what this crackdown really means, and what to do next.
A Conversation You Don’t Want to Miss
I’ll be moderating a discussion with two industry powerhouses who have lived and led through cycles of enforcement and reform:
Bob Dean — Former FDA Division Director in the Office of Prescription Drug Promotion (OPDP) and now Head of Global Labeling Strategy & Ad Promo at EMD Serono/Merck KGaA, Darmstadt Germany
Howard Dorfman, JD — Veteran regulatory and compliance attorney, former senior in-house and outside counsel, and adjunct professor of law
Bob and Howard called this back in 2023, when they warned that a new wave of enforcement was coming in this webinar that I also had the pleasure of moderating. Two years later, their prediction has arrived — and this time, the implications stretch across every communication channel and stakeholder touchpoint.
What’s Really Happening
This isn’t just about a stack of letters — it’s about a shift in tone and tolerance. The FDA is reminding the industry that while technologies have evolved, the rules have not: fair balance, substantiation, and risk communication are still non-negotiable.
We’ll Discuss:
An Opening Salvo: The FDA’s intent to reassert existing regulations,
Promotion in the Spotlight: How to promote responsibly within approved labeling
Scientific Exchange Boundaries: Navigating pre-commercial conversations without crossing the line
The Unbranded Trap: Why even disease-awareness or “education” campaigns can draw scrutiny
Before Another Shoe Drops: How to get your house in order before more letters arrive
Why This Matters
Over the past month, I’ve spoken with teams across pharma and biotech — MLR reviewers, marketers, med-affairs leaders, and agencies alike. The concern is universal: “How do we stay compliant without slowing down innovation?”
That’s exactly what this webinar will answer.
🗓 Webinar: FDA Crackdown 2025 — How to Stay Compliant as Enforcement Accelerates
🕑 Date: November 20, 2025 | Time: 2:00 p.m. ET (1 hour)
🎙 Moderator: Ilyssa Levins
👥 Speakers: Bob Dean and Howard Dorfman, JD
🏢 Sponsored by: BIO — The Biotechnology Innovation Organization