The FDA’s Centre for Biologics Evaluation and Research (CBER) has issued untitled letters to four pharmaceutical companies, marking an increase in enforcement activity after a period of relative dormancy. The move signals to pharma that, following last year’s focus on the promotion of small-molecule drugs, the agency’s scrutiny of promotional practices is now extending more broadly to the biologics sector.
Focus on ‘exploratory’ claims
On 9 March 2026, the FDA issued letters to Iovance Biotherapeutics, Bristol Myers Squibb, Novartis and Gilead’s Kite Pharma, raising concerns about the promotion of “exploratory analyses” such as overall survival (OS) and progression-free survival (PFS) that go beyond the outcomes supporting regulatory approval.
The Iovance letter noted that marketing materials referenced OS data despite approval being based on objective response rates. Similarly, the BMS and Novartis letters addressed the presentation of survival outcomes not established as primary clinical benefits. The Gilead/Kite letter covered materials referencing PFS, OS and relapse-free survival, while the product was approved based on response-based endpoints.
The agency’s correspondence also indicated that footnotes alone are not sufficient to support compliance where the overall promotional message may be misleading.
Implications for pharma marketers
The FDA’s actions highlight increased attention on promotional practices by biologics companies, particularly where claims may affect how risks and benefits are understood in clinical decision-making.
“This may cause doctors and patients to inaccurately weigh the risks versus benefits of treatment… which can be fatal or life-threatening,” the FDA broadly stated in each letter.
At least one company has responded publicly. “We take patient safety and compliance seriously and are working to ensure our communications are accurate, balanced and consistent with the prescribing information,” a Gilead spokesperson told Fierce Pharma.
For pharma marketers, these letters may signal a continued rise in CBER enforcement activity following a historically quiet period, underscoring the importance of adhering to promotional regulations.
