By Eliana Kosova, National Women’s Health Network
A few weeks ago, the Food and Drug Administration issued a proposal that would update the single-use female condom to a Level II classification, and rename it the “internal condom.” Following FDA procedures, they opened the proposal up to comments.
Here at the NWHN we were thrilled, since we’ve been making our voices heard, and pushing for changes to the female condom protocol for years! But first let’s cover some key background. What exactly is the female condom? And why is this FDA proposal so important?
The female, or internal, condom is a non-hormonal contraceptive that is similar to the male, or external, condom. Yet, unlike the male condom, the female condom is worn and controlled by the receptive partner inside the vagina or anus. This condom can be inserted up to eight hours before sexual activity.
While there’s little difference in the two kinds of condoms themselves, there has been a major difference in how they are regulated by the FDA. The male condom is classified by the FDA as a Level II product, which requires a lower level of regulation and scrutiny. But the female condom has been regulated as a Level III product, on par with medical devices like pacemakers.
This unnecessary distinction in classification prevents more companies from producing the female condom, and innovating its design. While countless brands of male condoms have been approved for sale, Veru’s FC2 female condom is the only brand of female condom that has ever been approved by the FDA.
Recently, Veru decided to take FC2 condoms off of pharmacy shelves and make them available exclusively through prescription. The company argues that by doing so, they ensure that women with health insurance can access them free of charge, thanks to the Affordable Care Act’s mandate for birth control coverage. However, the move also highlights the impact that the FDA classification has on limiting consumer choice: because of the internal condom’s current classification, the decisions of a single company can eliminate an entire contraceptive option for thousands of women and men.
This is why the reclassification of the female condom is so crucial. Its Level III classification is a barrier to what the product was made to do: empower receptive partners to take charge of their sexual health. By giving women the ability to arm themselves against pregnancy and STIs without having to rely on a partner using protection, the female condom places the power back into women’s hands.
The second element of the FDA’s proposal, renaming the female condom the “internal condom,” is also critical. Renaming the female condom would set the stage for greater inclusivity, especially when it comes to the LGBTQ community. An increasing number of people have begun to use the female condom for anal sex, and degendering the product makes it more accessible to a broader group of people. It could also help researchers consider how well the internal condom works to prevent the spread of STIs when it’s used in different ways.
Additionally, the name “female condom” reinforces the flawed notion that all women have vulvas and vaginas, and that all men have penises. When it comes to sexual health, we need to make sure that all people, regardless of their gender identity or sexual orientation, have the medical information they need to lead healthy and safe lives.
Join us in supporting this FDA proposal! Take action and speak out for women’s health by submitting your own comments in support of the proposal to the FDA before February 2, 2018.