We wish to respond to Dr Katz’s comments regarding advertisements for AMEVIVE (alefacept). Biogen Idec, Inc, holds its advertising to a high standard based on ethics and compliance with applicable law and regulations. The Food, Drug, and Cosmetic Act and federal regulations require advertising for a prescription drug or biologic product to be consistent with the information included in the product labeling. The approval of AMEVIVE was based on data from 2 phase 3 randomized, double-blind, placebo-controlled clinical studies. These registrational studies evaluated patients treated with either the IV or the IM formulation. Both studies provided key data in support of the product approval and are described in the product labeling.
Ticho B, Eickenhorst T. AMEVIVE’s Advertisements: Problematic?—Reply. Arch Dermatol. 2005;141(12):1602–1604. doi:10.1001/archderm.141.12.1604-a
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