For the second time, the FDA warned Fenwal about misleading promotional material for InterSol that omits risk information. The agency raises concerns about the repeated nature of the violations and is requesting the company implement procedures to prevent such violations in the future.
The Center for Biologics Evaluation and Research’s Office of Compliance and Biologics Quality issued a warning letter to Fresenius Kabi subsidiary Fenwal over misleading promotional material for InterSol (Platelet Additive Solution 3). The warning letter raises concerns about omitted risk information and continued violative promotion of the product because similar violations were observed in 2012.
InterSol has no direct therapeutic effect and is not meant to be infused into a patient. The warning letter takes issue with a presentation designed to introduce blood facility staff to the product, as it fails to disclose facts related to consequences that may result from the product’s use, including warnings and precautions and information pertaining to the risk due to direct infusion. Leaving out such information from promotional material renders the product misbranded.
The CBER calls on Fenwal to immediately stop disseminating the violative promotional materials, provide a written response listing all promotional materials used for the product that contain such violations, and outline plans to discontinue their use. Given the previous violations, the CBER also requests Fenwal provide a written response detailing which policies and procedures it plans to adopt to ensure its promotional activities comply with laws and regulations, as well as an explanation of how the policies are expected to succeed.