FDA Does Not Intend to Halt Sale or Distribution of Condoms Containing Nonoxynol-9
In response to an inquiry made last year by former Rep. Tom Coburn (R-Okla.) and Rep. Joseph Pitts (R-Pa.), the FDA has stated in a letter that it does not plan to halt the production, sale or marketing of condoms containing nonoxynol-9 (FDA letter, 2/2). In a letter to the General Accounting Office last August, Coburn and Pitts expressed concern over two studies, including a UNAIDS study reported at last year's 13th International AIDS Conference, showing that nonoxynol-9 can increase the risk of HIV transmission (Kaiser Daily HIV/AIDS Report, 8/25/00). The FDA, responding to the lawmakers' inquiry, said that it will not consider changing the labeling or marketing of condoms containing nonoxynol-9 until the UNAIDS study findings have undergone peer review. Although the FDA is currently conducting a "comprehensive" review of condom labeling, including the writing on outside box covers, package inserts and individual foil packs, the agency will not change any labeling practices until a "complete and thorough review of all available scientific evidence on condom use and effectiveness" has been conducted. The FDA, which approved the sale of condoms containing nonoxynol-9 in 1982, added that while it is "aware" of studies suggesting the spermicide can increase the risk of HIV transmission, it does not know of any "peer-reviewed studies from 1989 to the present that show a direct causal link between" the two. And while the agency requested data from UNAIDS on the topic last September, it has not yet received any data, according to the letter. The findings from the conference are currently under review and should be made available "shortly," the letter concluded (FDA letter, 2/2).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.