The Food and Drug Administration (FDA) on Wednesday authorized the first condom for use during anal intercourse, green-lighting the use of the Global Protection Corp’s One Male Condom.
While regular condoms are already recommended for anal sex, they are required to be marketed specifically towards vaginal sex. The move by the FDA is seen as a victory for sexual health by experts and can especially be important for the LGBT community.
Sexual health advocates considered this an unmet public health need since unprotected anal intercourse carries the greatest risk of HIV transmission via sexual exposure, with one study finding that 69 percent of men who have sex with men would use condoms more frequently if they were FDA-indicated.
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.
