Biologics

CBER Warns Against Unsupported Survival Claims in Biologic Promotions

CBER’s Advertising and Promotional Labeling Branch (APLB) is warning biologic marketers against using progression-free survival and overall survival data from single-arm studies to support promotional claims that cannot be substantiated by the underlying clinical evidence.

Speaking at a 10/28 Food and Drug Law Institute advertising and promotion conference, APLB chief Christine Cooke said her staff have recently issued four compliance letters involving misleading claims about the benefits of biological products. She highlighted promotional presentations involving survival endpoints, explaining that time-to-event outcomes from single-arm studies can be difficult to interpret without an appropriate comparison group.

Such studies may not establish whether an observed survival outcome resulted from the treatment itself or from other factors, including the natural history of the disease, she said. The concerns are particularly relevant to oncology biologics, including products developed through accelerated approval pathways that may rely on single-arm clinical trials.

Cooke said manufacturers should ensure that promotional claims are supported by scientifically sound evidence and that materials accurately communicate study limitations, indications and safety information. She also identified recurring problems involving overstated efficacy, omitted or minimized risks and the use of disclaimers to support conclusions drawn from inadequately designed studies.

CBER reviewed about 13,500 promotional pieces during FY 2026, according to Cooke, with consumer-directed materials accounting for about 24% of the total. Cooke encouraged manufacturers to coordinate with CBER early, particularly when preparing promotional campaigns for newly approved biologics.

Her presentation underscored FDA's continuing scrutiny of claims that may exaggerate treatment benefits or draw unsupported conclusions from clinical trial results.

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Review Extended on Agios sNDA for Sickle Cell Drug

Cassidy Proposes New FDA Review Authorities for AI Medical Devices

FDA Removes More Estrogen Patch Boxed Warnings

AMA Urges FDA to Uphold ‘Rigorous Standards’ for Botanicals