The trend: More FDA enforcement letters are being sent to pharma TV advertisers in 2026, signaling a tougher regulatory posture and a more critical lens on how claims are framed and presented in direct-to-consumer (D2C) ads.

• In an FDA letter to Johnson & Johnson this month, the FDA called its Tremfya TV ad false or misleading, arguing that its claim that “1 out of 2 patients” achieved remission after a year excluded patients who failed to respond initially. The agency also objected to the phrase “100% visible healing,” noting that the clinical endpoint measured remission, not total healing.
• In another February letter, the FDA challenged Novo Nordisk’s Wegovy pill campaign, disputing phrases like “Live Lighter” and “a way forward” as overstating emotional outcomes. The agency also cited technical noncompliance, including failure to match required on-screen risk text with spoken audio.

Catch up quick: Federal scrutiny of pharma D2C advertising began ramping up late last year. We estimate that healthcare and pharma marketers spent $5.56 billion on TV advertising in 2025.

In September, President Trump signed a memorandum directing the HHS to crack down on pharma advertising on TV and channels like social media. As part of that directive, the FDA said it would revert to pre-1997 drug advertising laws and require drugmakers to disclose all risks in ads.

Around the same time, the FDA sent more than 100 “cease and desist” broad enforcement letters, including about 40 specific untitled letters targeting TV drug ads from Big Pharma companies, including AbbVie, Boehringer Ingelheim, Novartis, and Pfizer.

Why it matters: The rising volume and sharper tone of FDA enforcement letters signal a meaningful shift in enforcement for drugmakers that rely on D2C advertising, especially TV advertising.

• So far in 2026, the FDA has sent 8 untitled letters warning pharma advertisers about misleading promotions, following 50+ letters sent last year.
• The scale marks a departure from the norm. Since 2014, the FDA hasn’t issued more than 11 regulatory action letters on drug promotions in any single year, per a RAPS’ analysis.
• While the FDA doesn’t impose fines, requiring drugmakers to change or remove ads considered out of compliance forces brands and agencies to review and recreate work, adding unplanned legal, medical, and production work.

Implications for pharma brands and agencies: As FDA enforcement accelerates, drugmakers and their agencies will need to recalibrate how they approach D2C creative and compliance. The familiar playbook of shortened risk presentations, selectively presented clinical data, and emotionally exuberant phrasing may no longer work in the stricter review environment.

The likely result is more cautious messaging in promotions, as well as exact clinical data usage, and longer review times for legal and medical teams. Even without formal rule changes, continued enforcement could effectively reset expectations, raising the compliance bar and reshaping pharma ad norms.

This content is part of EMARKETER’s subscription Briefings, where we pair daily updates with data and analysis from forecasts and research reports. Our Briefings prepare you to start your day informed, to provide critical insights in an important meeting, and to understand the context of what’s happening in your industry. Not a subscriber? Click here to get a demo of our full platform and coverage.