Most recent studies indicate condoms do not safeguard against human papillomavirus, or HPV, a little-known but widespread sexually transmitted disease that, untreated, can cause genital warts or cervical cancer.
The FDA "has developed a regulatory plan to provider condom users with a consistent labeling message and the protection they should expect from condom use," Dr. Daniel G. Schultz, director of the agency's Office of Device Evaluation, said Thursday.
The agency "is preparing new guidance on condom labeling to address these issues," Schultz told members of a House Government Reform subcommittee.
Package labels now say that condoms, if properly used, reduce the risk of AIDS and other sexually transmitted diseases. The labels are silent on the issue of HPV. The question now is whether that statement needs to have any additional information regarding protection against the cervical cancer virus — without discouraging people from using condoms for AIDS protection.
The FDA has considered warning labels since 2000, when President Clinton directed the agency to re-examine whether information included in packages accurately reflected condom effectiveness in preventing all sexually transmitted diseases, including HPV.
But some lawmakers feared that such labels could turn people away from using condoms, thereby increasing the risk of contracting diseases such as AIDS, chlamydia and gonorrhea.
"Anything that undermines the effectiveness of condoms for these uses will have serious public health consequences," said Rep. Henry Waxman, D-Calif. "Are condoms perfect? Of course not. But reality requires us not to make a public health strategy against protection, but rather to ask a key question: compared to what?"
Some lawmakers "insist that abstinence-only education is the solution to teen pregnancy and sexually transmitted diseases because abstinence works each time," Waxman said. "Well, the evidence, however, indicates that abstinence-only education works rarely, if at all."
Responded Rep. Jo Ann Davis, R-Va.: "This is not about social ideology, or religious ideology. It's about informing women. ... And truly, the only way to be protected is abstinence. That's not ideology — it's fact."
The White House wants to double, to $270 million, federal spending on education programs to convince young people that abstinence is the only certain way to prevent the spread of sexually transmitted diseases. But an independent report for the government two years ago indicated that no reliable evidence exists that abstinence programs work.
More than 2 million American women are infected with HPV each year, said Dr. Ed Thompson, deputy director for public health services at the Centers for Disease Control. Ten thousand women are diagnosed annually with cervical cancer, claiming 4,000 lives, Thompson said.
By Lara Jakes Jordan