FDA Authorizes First Condom for Anal

Gary Snyder, HIV Prevention, Erie County Department of Health

On February 23rd this year the US FDA made headlines that gave people pause and some to scratch their heads. 'A condom can be used for anal sex'… Surely the Food and Drug Administration is aware that condoms have been used by the public for anal sex for quite some time now, right? In fact, they have been aware of this use but the news is about something a little different. Specifically, three types of condoms from one manufacturer/brand have been approved for anal. Prior to this announcement, the FDA had not officially cleared or approved condoms specifically for anal intercourse. How could this be? Well, there's some backstory here to help us understand why the authorization is actually an important step in advancing the use of condoms.

Condoms are regulated as Class II devices under the FDA as established by the Federal Food, Drug, and Cosmetic Act; which has a comprehensive system regulating medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes the categories or classes of said devices. These regulatory guidelines assure safety, efficacy, and labeling of approved products. With that technical stuff out of the way, prior to February 23, 2022, the FDA did not give any condom companies the ability to list anal sex in the 'Indication for Use'; which means they've been labeled as 'save and effective' for vaginal use only. Now why would the FDA do that? Quite simply, there has not been data via reported and verifiable studies on the safety of condoms for anal sex provided to the FDA. That was until recently.

Global Protection Corp., the company that manufacturers the ONE® brand condoms, on August 26th last year [2021] cited a study from the Rollins School of Public Health at Emory University as the foundation of their 'De Novo Request' to the FDA to expand the intended use to include anal sex. The study was led by Dr. Aaron Siegler, an Associate Professor of Epidemiology, for the largest clinical trial of effectiveness of condoms for anal sex ever conducted. Dr. Siegler is also Associate Director of the Emory Center for AIDS Research (CFAR) Prevention Sciences Core and began funding pursuits in 2012 for a partnership with the Global Protection Corporation. The study was funded by the National Institutes of Health (NIH) with the results being published in Lancet's EClinicalMedicine in 2019.

This study from Emory University found that ONE® and myONE® Condoms used during anal sex failed less than 1% of the time (0.7%). Earlier studies for a similar outcome measurement had reported condoms having a 6% to 7% failure rate for anal sex. One key item of that research from before was not requiring condom-compatible lubricant with anal sex. When it came to vaginal sex, the FDA cleared condoms based on a clinical failure threshold of less than 5.0%. Because the Emory University study took into account condom-compatible lubricant. This resulted in an additional update for using lubricant during anal sex as part of the new FDA label indications. This FDA approval specifically applies to three different types of ONE® Condoms; standard, thin and myONE® custom-fit condoms which come in 60 different sizes. More information on the condoms is available at: www.myonecondoms.com

"The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. The FDA'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," said Courtney Lias, Ph.D., director of the FDA's Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health. "Furthermore, this authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations. This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster."

Further details can be found online at: https://tinyurl.com/analsexcondom