In a letter dated July 7, 2008, the FDA warned that Baxter’s promotion for its bleeding treatment FEIBA VH misleads doctors about the drug’s safety and effectiveness. (Chicago Tribune/Bloomberg News 7/31/08: “Baxter Warned on Hemophilia Drug Promotion.”)

The FDA advised that the "clinical thank you e-mail" submitted for review by Baxter violates FDA policies and is misleading with respect to both the efficacy and the safety of the drug. Specifically, the FDA held that the promotion overstated the efficacy of the drug and minimizes the fact that serious thrombotic events can occur with the drug. In its letter, the FDA states:

"This Email makes false or misleading safety and efficacy claims for FEIBA VH. Therefore, this material misbrands FEIBA VH in violation of the Federal Food, Drug and Cosmetic Act (the Act) 21 U.S.C. §§ 352(a) and 321(n), and FDA implementing regulations. Cf. 21 CFR 202.1 (e)(6)(i) and (iv). These violations are concerning from a public health perspective because by promoting misleading safety and efficacy claims, you are potentially encouraging the unsafe use of FEIBA VH."

A complete copy of this letter is available by clicking here.

After the heparin debacle, one would hope that Baxter would not be so quick to overstate the safety of its drugs. Apparently, as the old idiom warns, a leopard can never change its spots.

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