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GAO-08-565R 1 (2008-04-25)

handle is hein.gao/gaobadxgu0001 and id is 1 raw text is: A 0 .,!! = Accountability * Integrity Reliability United States Government Accountability Office Washington, DC 20548 April 25, 2008 The Honorable Tom A. Coburn, M.D. Ranking Member Subcommittee on Federal Financial Management, Government Information, Federal Services, and International Security Committee on Homeland Security and Governmental Affairs United States Senate Subject: Food and Drug Administration: Agency Complied with Statutory Requirement to Reexamine Condom Labels Dear Senator Coburn: Sexually transmitted diseases (STDs) affect men and women of all backgrounds and economic levels and remain a major public health challenge in the United States.' While substantial progress has been made in preventing, diagnosing, and treating certain STDs, an estimated 19 million new infections occur annually.2 According to the Centers for Disease Control and Prevention (CDC), correct and consistent use of a male latex condom can reduce, but not eliminate, the risk of STD transmission. Although male latex condoms have been proven to be highly effective in preventing HIV/AIDS, concerns have been raised over the past decade that condom labels do not include accurate information about condoms' effectiveness in preventing other STDs, including the human papillomavirus (HPV). A provision enacted as part of the Consolidated Appropriations Act, 2001, required the Secretary of Health and Human Services (HHS) to reexamine existing condom labels3 to determine whether they are medically accurate regarding the effectiveness of condoms in preventing STDs.4 You asked us to address issues related to condom labels. In this report, we discuss the scope of this statutory requirement and assess the extent to which the Food and Drug Administration (FDA)-the agency within HHS responsible for the regulation of medical devices, including condoms-complied with the requirement. 'Included among STDs are HIV/AIDs, the human papillomavirus, gonorrhea, syphilis, and chlamydia. 2Centers for Disease Control and Prevention, Trends in Reportable Sexually Transmitted Diseases in the United States 2004, National Surveillance Data for Chlamydia, Gonorrhea, and Syphilis (November 2005). 3The term label generally refers to the written or printed matter on the immediate container of a device, while labeling refers to all labels and other printed materials on or accompanying a device. 21 U.S.C. §§ 321(k), (m). 4Pub. L. No. 106-554, app. A, § 516(b), 114 Stat. 2763, 2763A-73 (2000). Throughout this report, we refer to this provision as section 516(b). GAO-08-565R Condom Labeling

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