Food and Drug Administration: Agency Complied with Statutory Requirement to Reexamine Condom Labels

GAO-08-565R: Apr 25, 2008

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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. 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 labels to determine whether they are medically accurate regarding the effectiveness of condoms in preventing STDs. Congress 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.

FDA reviewed studies on the relationship between use of male latex condoms and STDs and determined that existing condom labeling did not provide complete information about the effectiveness of condoms in preventing the transmission of certain STDs. Section 516(b) required that the agency reexamine existing condom labels for medical accuracy with respect to STDs; it did not require FDA to take specific regulatory action. Thus, FDA's actions complied with the statutory requirement. FDA reviewed available scientific information related to condom effectiveness, including its own evaluations and those conducted by other federal agencies. These studies addressed the effectiveness of condoms in preventing a range of STDs, including HPV. Among other things, FDA noted that condoms provide less protection against HPV, which can have multiple routes of transmission, than against certain other STDs. However, FDA found that condoms, when used correctly and consistently, can be effective in reducing the risk of transmission. Based on its review, FDA found limitations in existing condom labeling and identified several areas in which improved labeling would help provide reasonable assurance of condoms' safety and effectiveness. As a result, FDA initiated regulatory action under the Federal Food, Drug, and Cosmetic Act to improve condom labeling with regard to STDs.