FDA panel examines HIV microbicides
A Food and Drug Administration panel convened Wednesday in Washington, D.C., to discuss ways to test HIV microbicides, compounds developed to help prevent HIV infection through sexual contact. The panel examined such issues as how long an experimental microbicide trial should be, what data would need to be collected to prove the effectiveness of a microbicide, and whether the trials should compare the effectiveness of microbicides to condom use and/or a placebo.
"There is extreme urgency to develop a topical microbicide rationally and get it on the market as soon as possible," Debra Birnkrant, director of the FDA's division of antiviral drugs, told the Dow Jones News Service. "We've been wrestling with these issues for a few years now."
The panel did not reach any consensus on the issues and agreed to meet later this year for further discussion. Panel members did note that the first experimental microbicide to undergo clinical trials would likely face stringent testing and data-gathering requirements. Microbicide researchers hope to have an effective product on the market by 2007.