GAO reports on condom effectiveness against HPV
This article was originally published in The Gray Sheet
Executive Summary
FDA is considering revised condom labeling stating that the devices may not protect against transmission of human papillomavirus (HPV) as well as they protect against other sexually transmitted diseases such as HIV, according to a recent report by the Government Accountability Office. The report responds to concerns raised earlier by Sen. Tom Coburn, R-Okla., who is a physician, as well as other members in Congress. Based on an FDA review, the report updates the results of a study published in the June 22, 2006, edition of the New England Journal of Medicine in which investigator Rachel Winer, University of Washington, found that women whose partners used condoms every time they had sex were 70% less likely to acquire a new infection of HPV than women whose partners used condoms less than 5% of the time ("1The Gray Sheet" June 26, 2006, In Brief). FDA concluded that there are limitations in existing condom labeling and identified several areas in which improved labeling would help provide reasonable assurance of safety and effectiveness