FDA warns Gilead, Biogen Idec over drug promotions

The FDA on Wednesday posted on its website letters the agency sent to Gilead and Biogen Idec warning the drugmakers about misleading promotions for HIV drug Truvada (emtricitabine/tenofovir) and multiple sclerosis therapy Tysabri (natalizumab), respectively.

In its letter to Gilead, the agency said a direct-to-consumer print advertisement for Truvada was "false or misleading" because it overstated the effectiveness of the drug and failed to adequately warn of its risk.

Biogen Idec, meanwhile, was cited for minimising the risk of a brain infection associated with Tysabri, which the drugmaker co-markets with Elan, in a promotional webcast and was also warned for failing to submit the webcast for FDA review 30 days prior to its use.

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