Are branded drugmakers trying a new tack to battling generic competition? The Federal Trade Commission wants to know. Some generics makers have complained to the agency that branded manufacturers won't sell them bulk quantities of certain meds, making it tough for copycat drugmakers to figure out how to make their copies. But the real wrench in the works may actually be FDA.
In a letter to FTC, generic heavyweight Teva Pharmaceutical Industries accuses GlaxoSmithKline, Novartis and Bayer of refusing to supply particular drugs. For instance, Glaxo refused to deliver its Promacta drug, saying that Teva is not an authorized recipient under an FDA risk management program. Teva says Glaxo has also declined to sell it samples of cancer drugs Tykerb and Hymactin. A Glaxo spokeswoman told the Wall Street Journal that the company would be happy to supply Promacta to Teva as long as FDA approves.
Dr. Reddy's says it can't get ahold of Celgene's multiple myeloma drugs Revlimid and Thalomid; that company also cited safety issues for the refusal. Dr. Reddy's has filed a petition with FDA, asking the agency to rule on whether safety concerns are a valid excuse for the manufacturers' holding these meds close to the vest.
Meanwhile, the FTC says it's concerned about the sales holdup (but won't say whether it's opened an investigation). "You can't let drug safety be used as a tool to delay generic competition," FTC Chairman Jon Leibowitz told the Journal.
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