There is an urgent need for new prevention approaches to HIV infection (1). The principal interventions used to date have included condoms, risk-reduction counseling, and voluntary HIV testing. However, these interventions have been inadequate and there has been a cry for “new tools in the HIV prevention toolbox.” One such new tool is HIV preexposure prophylaxis (PrEP), the treatment for persons who are HIV-negative and at high risk for infection with antiretroviral drugs, which has now been studied in several randomized clinical trials, using Truvada (Gilead Sciences, Foster City, California), a licensed combination pill consisting of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). On the basis of these and other studies, the manufacturer of Truvada, Gilead Sciences, submitted a new drug application to the U.S. Food and Drug Administration (FDA) for approval of a PrEP indication. On 10 May 2012, the FDA Antiviral Drugs Advisory Committee, of which I was a member, met to advise the agency on this application.