FDA warns Biogen, Gilead on DTC promos

Continuing its tougher stance on drug company advertising, the FDA sent out warning letters to Biogen Idec and Gilead Sciences, citing them for minimizing the risks of treatment with their drugs.

Biogen got slapped for a promotional webcast that featured its multiple sclerosis drug Tysabri. The FDA states the webcast "seriously" minimized the risk of progressive multifocal leukoencephalopathy, a potentially fatal brain infection that has cropped up in some patients using the drug. PML was the spur for Tysabri's withdrawal from the U.S. market back in 2006; the drug was reintroduced under a risk management program, and some 42 PML cases have arisen in Tysabri patients since then.

Meanwhile, Gilead was cited for a print ad promoting its HIV drug Truvada. The agency says the ad overstates Truvada's effectiveness, using images of a woman who "appears to be happy and in good health" at various ages in her life. That suggests "that Truvada is better or more effective than has been demonstrated," the FDA says, because it implies that Truvada will manage HIV disease long-term, but it's only been studied for three years. Although the ad mentions that three-year study, the "prominent images" outweigh it, the agency maintains.

Biogen disagrees with the FDA's conclusion about its webcast and says it will work with the agency on a solution. Gilead says it takes the warning seriously and will respond directly to FDA.

- see the Reuters story
- read the Wall Street Journal Health Blog post