The Advertising and Promotional Labeling Branch of the FDA’s Center for Biologics Evaluation and Research (CBER) has informed ZymoGenetics that promotional information on its website regarding the coagulation protein Recothrom is “false or misleading.”
The agency noted in a letter to the company that its promotional material misbrands Recothrom, making it in violation of the Federal Food, Drug, and Cosmetic Act, because it “omits material facts about Recothrom” (Recombinant).
Recothrom is a coagulation protein produced via recombinant DNA technology from a genetically modified Chinese hamster ovary cell line, according to the FDA. Recothrom is currently indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.
The agency specifically cited the following phrase, located within the Newsroom section of ZymoGenetics’ website as false or misleading: “A Phase 3 pivotal clinical trial showed that Recothrom had comparable efficacy and a significantly lower incidence of antibody formation compared to the commercially available bovine thrombin product.”
The agency noted that it suggests that “Recothrom is safer than the bovine thrombin product due to a lower incidence of antibody formation in the patients who took the Recothrom. However, this statement excludes important contextual information necessary to understand the limitation of this finding.”
In determining whether promotional materials are false or misleading, FDA said it takes into consideration not only the representations made or suggested in such materials, but also the extent to which the promotional materials fail to reveal facts that are material in light of the representations, or that are material with respect to the consequences which may result from the use of the product.
As a result of its findings, the FDA requested that ZymoGenetics “cease the dissemination of the violative promotional material for Recothrom,” and that the company submit a written response within 10 business days of receiving the letter.