The news: The FDA is cracking down on pharma marketing again, sending letters to four companies over what it says are false or misleading promotional claims for biologic cancer drugs.

Bristol Myers Squibb’s Breyanzi, Novartis’ Kymriah, Gilead’s Tecartus, and Iovance Biotherapeutics’ Amtagvi recently received letters focused on healthcare provider websites and in sales materials, including survival data claims and inaccurate portrayals of clinical trial results.

Why it matters: The latest letters came from the FDA’s biologics division, the Center for Biologics Evaluation and Research (CBER), signaling the agency is expanding the pharma marketing crackdown it began last fall.

• In September, President Trump instructed the HHS and the FDA to crack down on pharma drug advertising, followed by numerous more letters over the last few months citing regulatory violations across TV, social media, and digital channels.
• Some biologics like AbbVie’s Skyrizi and Novartis’ Kesimpta were part of the FDA’s initial sweep, but those letters focused on direct-to-consumer marketing.
• Before the March letters, CBER had warned only one biologic drugmaker with a letter since 2019—AstraZeneca for a Flumist TV ad in 2025.

Implications for pharma and biotech companies: Biologics and cancer drugs are clearly in the FDA crosshairs. The FDA isn’t just focusing on D2C TV commercials and social media influencer campaigns—it’s also scrutinizing direct-to-physician scientific marketing and whether claims mislead or overpromise. That could affect how aggressively companies promote some of their highest-value drugs, and push marketing, medical, and legal teams toward more conservative claims and longer campaign lead times.

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