Though public health experts have long advised the use of condoms for anal sex to protect against H.I.V. and other infections, regulators did not have enough data to allow marketing for that use.
For the first time, U.S. regulators have officially authorized a condom to be used for anal sex, not just vaginal sex.
The decision, announced by the Food and Drug Administration on Wednesday, has long been sought by sexual health experts, who said it could encourage more people who engage in anal sex to use condoms to protect themselves against H.I.V. and other sexually transmitted infections.
The risk of sexually transmitted diseases is “significantly higher” during anal sex than vaginal sex, an F.D.A. official said Wednesday. But until now, there has not been enough data to show that condoms are safe and effective during anal sex.
“The F.D.A.’s authorization of a condom that is specifically indicated, evaluated and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse,” Courtney Lias, director of the F.D.A. office that issued the approval, said in a statement.
The decision applies to a condom manufactured by Global Protection Corp. called the ONE male condom. Last year, the company asked the F.D.A. to allow it to add anal sex to the intended use of the condom on the product label, based on a study showing the failure rate, defined as slippage or breakage, to be less than 1 percent during anal sex.
The F.D.A. said in the statement that other condom companies would now be able to apply for similar approval by submitting claims that their condoms demonstrated “substantial equivalence” to the evidence shown for ONE condoms.
“I don’t think this is viewed as something that should be restricted, but rather something that opens the door for other companies to rigorously assess their condoms and show that they also perform well for anal sex,” said Aaron Siegler, an epidemiologist at Emory University who helped lead the study that prompted the F.D.A. decision.
Davin Wedel, president and founder of Global Protection Corp, said, “I think most people would be surprised to know that condoms are not approved for anal sex. With this new designation from the FDA, consumers will have important information about the safety and effectiveness of condoms for anal sex.”
The federal agency had previously said that condoms needed to have less than a 5 percent failure rate, and earlier studies of condoms for anal sex had shown failure rates higher than that.
As a result, while using condoms for anal sex is recommended by public health authorities like the World Health Organization and the Centers for Disease Control and Prevention, it has been considered an “off-label” use in the United States. Companies have not been able to market condoms for anal sex, said Dr. Kenneth Mayer, the medical research director for Fenway Health, a community health center in Massachusetts that has long been a leader in treating patients who identify as L.G.B.T.Q.
“It’s a great thing if the package inserts could indicate anal sex because it might create an incentive for the companies to do more marketing,” Dr. Mayer said. “You don’t see condom ads on gay social media, for example, so this would incentivize that as part of part of the conversation.”
“And it’s not just gay men.” Dr. Mayer continued. “It’s not that heterosexuals who engage in anal sex are unaware that condoms exist, but there’s been very little education, so it’s somewhat out of sight out of mind.”
Condom use during anal sex has declined in recent years, since the advent of a method to prevent H.I.V. infection called pre-exposure prophylaxis, or PrEP, which involves taking a daily pill. According to the most recent statistics from C.D.C.’s National H.I.V. Behavioral Surveillance data, about 46 percent of men who have sex with men were having anal sex without condoms in 2017, compared to 28-to-40 percent in 2011.
But although PrEP is very effective, there can be issues with cost and access. Currently, only about a third of men who are at high risk for H.I.V. infection are taking the drug, the C.D.C. reported.
“That’s hundreds of thousands of people,” said Dr. Mayer, who was not involved in the study that led to the F.D.A.’s decision. “And certainly those are individuals who would benefit from condoms.”
He added that condoms are the most effective protection against other sexually transmitted infections, including syphilis, which has been increasing in the United States.
To try to amass data that could lead to the approval of condoms for anal sex, the company teamed up with researchers at Emory University, met with the F.D.A. and designed a study.
Funded by the National Institutes of Health, the study, the largest to date on condom effectiveness during anal sex, was conducted between May 2016 and May 2017. It involved 504 men, half of whom had sex with men and half of whom had sex with women, and the researchers took several steps designed to encourage more consistent and accurate data than previous studies, Dr. Siegler said.
After being trained in proper condom use, the men were given condoms and asked to fill out a daily diary on a phone app, to answer questions about whether they had had sex that day and whether the condom they used broke or slipped. The participants reported 2,351 anal and 2,533 vaginal sex acts during the study period.
Dr. Siegler said that the team had hypothesized that the condom failure rate during anal sex would be low enough to pass muster with the F.D.A., but had not expected it to be as low as it was — 0.7 percent — or that it would be lower than the failure rate during vaginal sex, which was 1.9 percent.
The researchers attribute the higher failure rate during vaginal sex to the fact that the study encouraged lubricant appropriate for condoms to be used for every instance of anal sex, but, adhering to public health guidelines, only encouraged lubricant to be used during vaginal sex “as needed or desired.”
So, while 98 percent of people who had anal sex used lubricant, only 42 percent of those who had vaginal sex did. When the researchers looked only at people who used lubricant, the failure rate in the vaginal group was 1.1 percent, making the odds of failure in each group essentially the same, the study reported.
Public health experts said that suggests that lubricant was critical to the study’s results, and in its statement, the F.D.A. said that during anal sex, the condom “should be used with a condom-compatible lubricant.”
The study involved three different types of the One condom — standard, thin and fitted, which comes in 54 different sizes. They did not have ribbing or other characteristics, Dr. Siegler said. Each participant was given five samples of each type of condom to use for two to four weeks. The researchers had expected the fitted condoms to have the lowest failure rate, but the study found there was no difference, an outcome that Dr. Siegler said he thought reflected that all three varieties had to meet the same manufacturing and durability standards.
Dr. Siegler, who specializes in research on PReP, said that before conducting the condom study, the Emory team wondered whether adding anal sex to a condom label would encourage more men to use condoms.
“Does this matter? Would it change use?” he asked. The team conducted a survey of more than 10,000 men who had sex with men and found that 69 percent said that if the F.D.A. approved condoms for anal sex, they would be more encouraged to use them.
“I don’t see condoms versus PReP as kind of mutually exclusive options, I see them as options that can support each other and that allow people that choice,” he said. “There isn’t perfect use of any one technology. But if we optimize people’s access to and understanding of different prevention options, I think we can increase the overall population level protection against H.I.V.”
Dr. Mayer said he also saw adding the label to condoms as an additional tool that could help improve the use of all protective measures.
“It’s definitely not a one-size-fits-all kind of kind of environment,” Dr. Mayer said. “It will help normalize the conversation because there’ll be an economic incentive for the companies to advertise condoms for anal sex.”