The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution.
FDA first approved Fenwal's new drug application (NDA) for InterSol (500mL platelet additive solution 3) in 2009 as a storage solution to replace a portion of the plasma in platelets collected via the company's Amicus apheresis devices.
In a warning letter sent to Fenwal in October 2016, FDA cites the company again for omitting risk information about InterSol in a set of presentation slides intended for blood collection facility staff.
"The promotional material is misleading because it presents efficacy claims for InterSol, but omits all risk information … Therefore, your material misbrands InterSol under Sections 502(f)(2) and 201(n) of the Federal Food, Drug, and Cosmetic Act," FDA writes.
Due to the repeat nature of these issues, FDA says it expects Fenwal to notify it in writing about changes to the company's policies and procedures to ensure it complies with prescription drug promotion requirements going forward.
2012 Warning Letter
In 2012, FDA issued a warning letter to Fenwal over three of the company's promotional materials for InterSol, which the agency said contained unsubstantiated claims, broadened its indication and omitted risk information.
However, in 2014 FDA would approve updated labeling for InterSol that supported those claims based on clinical data from a retrospective review of some 14,000 transfusions that found a lower adverse event rate (0.55%) for transfusions with InterSol, compared to 1.37% adverse rate for transfusions using only plasma platelets.
As with the more recent warning letter, FDA cited Fenwal for failing "to provide any risk information pertaining to the use of InterSol including the warning, precautions and the risk due to direct infusion."
FDA also called Fenwal out for unsubstantiated statements that appeared in the company's promotional materials.
While the claims cited data from two abstracts published by the American Association of Blood Banks, at the time FDA said it was "not aware of substantial evidence or substantial clinical experience demonstrating these findings for InterSol."
However, in 2013 FDA closed out the warning letter, finding that the company addressed the issues cited in the warning letter.