FDA Releases Draft Guidelines for Latex Condoms; Packages Would Say They ‘Greatly Reduce But Do Not Eliminate’ Risk of HIV, PregnancyFDA on Thursday published a draft guidance document for latex condom manufacturers and opened a 90-day public comment period on the regulations, including a proposal to require labels to state that condoms "greatly reduce, but do not eliminate," the risk of pregnancy and HIV infection when used correctly during sexual intercourse, the Los Angeles Times reports. The new warnings must be included on all latex condom labels within one year of their final approval. FDA previously only has required condom labels include a warning about allergic reactions to latex (Neuman/Alonso-Zaldivar, Los Angeles Times, 11/11). The proposed language for the labels also says that condoms provide "less protection" from other sexually transmitted diseases, including human papillomavirus -- which causes most cases of cervical cancer -- and herpes because those STDs can be spread through skin-to-skin contact. However, the guidance also says that "using latex condoms every time you have sex may still give you some benefits against these STDs" (Wetzstein, Washington Times, 11/11).
In August 2003, Rep. Mark Souder (R-Ind.) and Sen. Tom Coburn (R-Okla.), then a House member, wrote letters to HHS Acting Principal Deputy Inspector General Dara Corrigan questioning whether CDC and FDA were complying with a 2000 law aimed at providing increased and accurate HPV prevention education. According to Souder and Coburn, evidence presented in a July 2001 report prepared by CDC, FDA, NIH and USAID -- titled "Scientific Evidence on Condom Effectiveness for STD Prevention" -- concluded that there was no epidemiological evidence that condom use reduced the risk of HPV infection (Kaiser Daily Women's Health Policy Report, 8/25/03). Coburn earlier this year placed a hold on former FDA Commissioner Lester Crawford's nomination to head the agency because of concerns about FDA failing to implement the 2000 law. Coburn later lifted the hold on Crawford's nomination after FDA assured Coburn that it would implement the law, according to Coburn spokesperson John Hart (Kaiser Daily Women's Health Policy Report, 7/18).
Souder and Coburn on Thursday said FDA's new proposed guidelines overstate condoms' effectiveness at preventing HPV transmission (Harris, New York Times, 11/11). "This is speculation rather than scientific fact and is misleading," Coburn said in a statement, adding, "Such claims of protection should not be made without conclusive scientific data" (Coburn release, 11/10). FDA spokesperson Yier Shi said, "We consulted with other agencies, we reviewed findings [and] we evaluated hundreds of scientific studies" before releasing the proposed guidelines. Other groups expressed concern that adding additional warning labels to condoms might dissuage some people from using them. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America, said that FDA is "moving in the right direction" by proposing warning labels "based on science" but that the language "underplays the importance of condoms in preventing" STDs. She added, "They're still the best protection for sexually active individuals" (Los Angeles Times, 11/11).
The draft guidelines also recommend that people at risk of contracting HIV should not use condoms containing the spermicide nonoxynol-9, the AP/South Florida Sun-Sentinel reports (Lumpkin, AP/South Florida Sun-Sentinel, 11/11). Nonoxynol-9 works as a vaginal contraceptive by damaging the cell membranes of sperm, and some laboratory evidence has shown that the spermicide damages the cell walls of some organisms that cause STDs and is effective against some bacteria and viruses. However, according to data presented in January 2003, nonoxynol-9's membrane-damaging effect also can harm the cell lining of the vagina and cervix, possibly increasing the risk of contracting STDs, including HIV, among women who use it. FDA in 2003 concluded that nonoxynol-9 might increase a person's risk of contracting HIV, but the agency did not issue new consumer warning labels (Kaiser Daily HIV/AIDS Report, 4/12). The AIDS Healthcare Foundation welcomed the new FDA recommendation but said the warning already should have been in place. "It's behind the times," AHF President Michael Weinstein said, adding, "Condoms in today's world are much more used for disease prevention than pregnancy prevention" (Reuters, 11/10). Heather Boonstra, a health policy analyst at the Alan Guttmacher Institute in Washington, D.C., said the study FDA used to change its guidelines on nonoxynol-9 showed that women who used the spermicide three times a day, which is not typical usage, according to the Times (Los Angeles Times, 11/11).