FDA Cracks Down on Biologics Marketing Over Misleading Claims

The FDA’s Centre for Biologics Evaluation and Research has issued untitled letters to Iovance Biotherapeutics, Bristol Myers Squibb, Novartis, and Gilead’s Kite Pharma for misleading promotional claims.

The agency criticized the use of exploratory survival data-such as overall survival and progression-free survival-in marketing materials, despite approvals being based solely on objective response rates. Footnotes alone, the FDA noted, cannot correct a misleading overall message.

"This may cause doctors and patients to inaccurately weigh the risks versus benefits of treatment… which can be fatal or life-threatening," the agency warned.

Gilead responded publicly, stating it is working to ensure communications align with prescribing information.

The move signals a renewed focus by CBER on oncology biologics, ending a period of relaxed enforcement and underscoring strict compliance expectations.