Friday, January 15, 2010

FDA issues warning letters to several pharmaceutical companies

Earlier this week, the FDA posted warning letters on its site to four drugmakers - Lilly, Bayer, Amylin Pharmaceuticals and Cephalon - for making inaccurate or incomplete statements while promoting their drugs. Amylin, for instance, was tagged because its reps made remarks that Byetta can be used as a stand-alone therapy before the drug received approval. Bayer was chastised for suggesting its Mirena contraceptive women help would feel more romantic or intimate when, in fact, the side effects indicate the opposite may occur. A dosing card for Cephalon’s Treanda, which treats chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, minimized risk and a Lilly promotional piece for its Cymbalta antidepressant minimized risk and overstated efficacy. Go here and here for the full story.

No comments: