Risky business

Last week's positive FDA panel vote sets the stage for approval of the first drug to prevent HIV infection. The onus will now be on the agency and Gilead Sciences Inc. to design and implement a postmarketing education and surveillance program for use of Truvada emtricitabine/tenofovir that will provide high-risk individuals with access to the drug without encouraging risky behavior.

The Antiviral Drugs Advisory Committee voted 19-3 in favor of approval of the Truvada for high-risk men who have sex with men. It voted 19-2, with one abstention, in favor of approval in serodiscordant heterosexual couples...