Brightness Among the Clouds: Positive Women’s Health Efforts at the FDA

Taken from the July/August 2018 issue of The Women's Activist Newsletter.

When Scott Gottlieb was tapped as Commissioner of the Food and Drug Administration (FDA), the NWHN opposed his nomination due to his ties to Big Pharma and lack of commitment to women’s health. Recently, however, we have welcomed the FDA’s support as the agency processes a number of pending decisions that would give power back to women and other marginalized people. Right now, two key cases involving the internal condom and the Population Council’s new vaginal ring await FDA approval.

Reclassification of “Female” Condoms

On December 4, 2017, the FDA issued a proposal to change the single-use female condom’s classification from Level III to Level II, and rename it the “internal condom.” The NWHN and other women’s health advocates have been pushing for these changes ever since the FDA approved and set guidelines for the FC2 female condom in 2008. The FC2 female condom is a modified version of the first female condom, Reality, also known as FC1, was approved in 1993. Now, the FC2 is the only internal condom available in the United States. The implications of this proposal are as crucial today as they were a decade ago.

The internal (or female) condom is a non-hormonal contraceptive that is similar to the male (or external) condom. This condom is inserted inside the vagina or anus. When the internal condom is used vaginally, it can be inserted up to eight hours before sexual activity and it protects against sexually transmitted infections (STIs), including HIV/AIDS. (There is a lack of research on the internal condom’s effectiveness when used anally.) Unlike the “male” version, the internal condom is worn by the receptive partner. Because it is the first barrier method with HIV protection that can be controlled entirely by the receptive partner, the internal condom has huge implications for STI/HIV and pregnancy prevention. The internal condom is 75% to 82% effective in typical use, and 95% effective with perfect use.

Although there is little difference between these two types of condoms, the FDA regulates them very differently. The male condom is classified as a Level II product, which requires a lower-level of regulation and scrutiny. The internal condom is currently regulated as a Level III product, on par with medical devices like pacemakers. This unnecessary distinction in classification has increased the price of internal condoms, created a barrier to additional companies producing the device, and hampered innovation in design. While countless brands of male condoms have been approved for sale in the United States, Veru’s FC2 internal condom is only the second type of internal condom that has ever been approved by the FDA.

Recently, Veru decided to take FC2 condoms off of store shelves and make them available exclusively through prescription. The company argues doing so will ensure that health insurance will cover the costs of internal condoms, thanks to the Affordable Care Act’s (ACA) mandated birth control coverage. The move, however, highlights the FDA classification’s impact on consumer choice: because of the internal condom’s Level III classification, the decisions of a single company can eliminate an entire contraceptive and STI/HIV prevention option for thousands of people who lack health coverage. This is why the reclassification of the condom is so crucial. The Level III classification creates barriers to empowering receptive partners to take charge of their sexual health. The FDA proposal’s second element, renaming the product the “internal condom,” is also critical and welcomed by the NWHN. Degendering the product name makes it more accessible to a larger number of people — including people who use it during anal intercourse, and members of the LGBTQ community — since the term “female condom” reinforces the flawed notion that all women have vulvas and vaginas, and that all men have penises.

The FDA’s proposals will help ensure that all people, regardless of their gender identity or sexual orientation, have the medical information they need to lead healthy and safe lives.

New Contraceptive Option

In other contraceptive news, Annovera, a vaginal ring system developed by the Population Council is waiting for the FDA’s approval. This new vaginal ring is unique in that it includes a new progesterone derivative, Nestorone®, in combination with ethinyl estradiol, a hormone that has been used in previous vaginal rings. The combination of Nesterone® and ethinyl estradiol is intended to reduce side effects, compared to other vaginal rings on the market today. While popular vaginal rings such as the NuvaRing require users to obtain a new vaginal ring each month, Population Council’s vaginal ring “require[s] [...] only self-administered insertion and removal 13 times a year,” and lasts the entire year. The year-long vaginal ring also does not need to be refrigerated. The new ring is, thus, more environmentally friendly than the current version, which is appealing to many users.

And, Annovera offers opportunities to address some of the problematic aspects of long-acting reversible contraception (LARCs) such as intrauterine devices (IUDs) and implants. LARCs are very popular because they are covered under the ACA and offer long-term pregnancy protection with a single action, the initial insertion of the device. Although LARCs offer a unique set of benefits, women’s health advocates are concerned that LARC promotion could turn into coercion, becoming just the most recent in a long line of population control methods targeted at specific groups of women (i.e., women of color, low-income and uninsured women, indigenous women, immigrant women, women with disabilities, and people whose sexual expression is not respected). (See the NWHN-SisterSong Joint Statement of Principles on LARCs at:

A huge issue with LARCs centers upon their removal. Although covered under the ACA, women (particularly women with inconsistent health coverage) have experienced limited options for getting LARCs removed. And, “even insured women may face resistance from health care providers if they are perceived as wanting to remove an IUD or implant too early.” Because users themselves can both insert and remove the new vaginal ring, this problem can be prevented.

There are still a few unanswered questions about the vaginal ring, however. The effectiveness of the ring was studied primarily in women who were not clinically obese. Nearly one in four women of reproductive age have a body mass index (BMI) of 29 or more and are considered obese . Finding a contraceptive method that is both effective and safe for women with a BMI over 29 is difficult. Based on the limited number of these women in the clinical trial of the new ring, it appears to be equally effective for them. But further study and monitoring will be needed. This is particularly important because the link between high BMI and low socio-economic status means that people from marginalized communities would be more likely to experience the limitations of the new ring, if there are any.

Next Steps

While final decisions about both the internal condom and the vaginal ring lie with the FDA, the NWHN will continue to advocate for equality and inclusivity in matters of reproductive health. Our campaign to relabel and reclassify the internal condom celebrates how much progress we have made in our effort to right past wrongs. When the FDA’s internal condom proposal was released, the NWHN submitted comments to the FDA and issued a call to action to our members, urging them to voice their support. Moving forward, our advocacy around the new vaginal ring will continue to prioritize the needs of those who are marginalized and vulnerable.

Eliana Kosova is the NWHN Health Policy Fellow.

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