By Jennifer Corbett Dooren WASHINGTON--The Food and Drug Administration has delayed a decision on whether to approve Gilead Sciences Inc.'s (GILD) HIV drug Truvada to help prevent certain healthy but at-risk people from contracting the virus that causes AIDS. The agency had been expected to make a decision by around June 15. A Gilead spokeswoman said the company resubmitted a risk-management plan on June 4 at the FDA's request. The agency needs more time to review the plan, which is part of the drug's application and pushed the decision deadline to Sept. 14. The drug was reviewed last month by an FDA advisory panel for use in gay and bisexual men who don't have HIV and for heterosexual couples in which one person is HIV-negative. While the panel voted in favor of using Truvada in certain non-HIV-infected people, many panel members were critical of the risk-management program, which is aimed at helping doctors and patients properly use the drug. Most of the criticism was centered around whether a negative-HIV test should be required before Truvada could be started. Although Truvada is approved to treat HIV infection, it must be administered as part of a cocktail of other drugs. Federal health officials are already figuring out how to incorporate use of the drug in HIV-prevention programs and are developing guidelines about which patients would benefit most from treatment. In the U.S., about 1.2 million people are infected with HIV and about 50,000 new infections are diagnosed each year, a level that has been stable for the past decade. Medical experts say additional approaches are needed to lower the rate of new infections, but they are divided on whether Truvada should be approved. However, one concern is whether healthy people would take Truvada daily, which is necessary for it to work. Write to Jennifer Corbett Dooren at jennifer.corbett@dowjones.com
