CBER: Letter: Coagulation Factor IX (Recombinant) (BeneFIX) - Wyeth Pharmaceuticals, Inc.

Dear Dr. Carpenter: The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed a flashcard (“Comparison Flashcard” 206690-01) submitted by your firm for BeneFIX under cover of Form FDA 2253; flashcard. The flashcard is misleading because it presents unsubstantiated superiority safety claims for BeneFIX. Therefore, the flashcard misbrands BeneFIX under the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 352(a), and FDA implementing regulations. Cf. 21 CFR 202.1 (e)(6)(ii). These unsubstantiated superiority safety claims are concerning from a public health perspective because they suggest that BeneFIX is safer than has been demonstrated.