What if female condoms cost the same as male condoms? Despite their higher price, receptive sex partners of all genders are using female condoms for vaginal or anal sex, including to prevent HIV transmission. The Female Health Company, the world's largest manufacturer of the FC2 female condom, announced at an international conference in December that it had just sold its 500 millionth female condom.
At the Global Female Condom Conference, advocates, public health professionals, researchers and funders uniformly agreed that the female condom's biggest stumbling block is its cost. The FC2 (the only female condom brand currently available in the U.S.) typically costs between $2 to $3.50 each, three to four times that of a typical male condom selling commercially for less than $1. This cost differential adds up, whether you are a student scraping change together, a householder doing the weekly shopping or a health department negotiating a massive, public sector price contract for your free condom distribution program.
The "value for money" business case for female condoms is strong. They avert costs generated by HIV, sexually transmitted infections (STI), and accidental pregnancies. But the market for them is stuck in a vicious circle: Female condoms cost more to make than male condoms -- manufacturers (none of them large corporations) can't afford high-volume production to bring the per-condom price down -- costs remain high -- demand stays low due to unfamiliarity and high price.
Female condom advocates recommend various ways to breaks this cycle. Shifting focus toward the private retail sector and away from public sector sales to governments and international funders is one option. In the spirit of "go big or go home," at least one major distributor is courting the private sector by marketing female condoms as a luxury sex toy rather than a necessity. Only a huge expansion of the private retail market, however, would enable manufacturers to simultaneously support intensive high-cost private sector advertising while continuing to meet the urgent, ongoing need for low-cost public sector product.
Another way of expanding the market in developed countries would be to generate market competition by providing consumers with a broader range of female condom choices. While five different female condom models are on the market globally, only one of these (the Female Health Company's FC2) is available in the U.S. According to the National Female Condom Coalition, a U.S. advocacy group espousing this approach, bringing multiple female condom brands into the U.S. market -- with a variety of features to appeal to various tastes -- could stimulate the market, increase uptake and bring prices down by generating competition. Other female condom manufacturers would like to enter the U.S. market. The barrier preventing this is the U.S. Food and Drug Administration (FDA)'s outdated classification of the female condom.
Here's how the FDA's three-tiered classification system works: Very low risk devices, such as dental floss and tongue depressors, are in Class I and subjected to minimal FDA controls. Class II devices, capable of posing greater risk to users, undergo greater regulatory supervision to ensure their safety and effectiveness. Male condoms, sexual lubricants, powered wheel chairs and some pregnancy test kits are in Class II. Class III devices are those presenting the highest risk, such as replacement heart valves, pacemakers and breast implants. To get FDA approval to market these, manufacturers must present clinical trial data demonstrating the product's safety and effectiveness. New devices that the FDA has not evaluated in any form before automatically go into Class III until more is known about them.
In 1993, the Female Health Company presented the FCI (the world's first female condom, the predecessor to the FC2) to the FDA for approval as a Class III medical device because it was new and relatively little data on it was then available. The last two decades have produced abundant safety and efficacy data to justify moving the FC2 and other, equivalent female condoms to Class II. International female condom testing standards and product guidelines are now in place to instruct the industry and ensure product quality. In addition to the FC2, three other female condom models -- the Cupid, the Velvet and the O'Lavie (previously known as the PATH women's condom), -- have been evaluated and approved by the World Health Organization's prequalification procedures and are all on the market in several other countries.
A window of opportunity for updating the FDA's indication opened in early 2015 when the FDA announced that it was conducting a retrospective review of all Class III products to assess their appropriateness for that designation. The National Female Condom Coalition promptly launched a campaign for FDA down-classification (from Class III to Class II), on that grounds that it would:
- Induce other female condom manufacturers to submit their products for FDA review.
- Accurately reflect current scientific evidence regarding female condom safety, performance and efficacy.
- Align U.S. regulations in this area with global regulatory bodies.
If the FDA down-classified the FC2 female condom, then other female condom manufacturers could apply for FDA approval as "cleared medical devices," meaning that the FDA regards them as "substantially equivalent to another legally marketed device." To get this status, the other manufacturers must still prove to the FDA that their female condoms are appropriate for their intended use, packaged and labeled properly and produced in plants using high manufacturing standards.
Non-U.S. manufacturers have expressed strong interest in entering the U.S. female condom market but can't afford the very expensive and lengthy process of applying for a Class III consideration. Without their participation, we can't lower the cost of female condoms here or elsewhere.
This FDA down-classification of female condoms would also be a public service for women internationally. Many low- and middle-income countries tie their regulatory processes closely to U.S. FDA processes, in part to make international donors happy. Where that has happened, female condom brands other than the FC2 cannot be distributed because they lack FDA approval. Down-classification here will therefore help to expand female condom access overseas -- including in countries where more than 60% of all people living with HIV are young women (20-24) who are three times more likely to have HIV than their male peers.
Lowering the cost of female condoms is essential for several reasons:
- Lots of people of all genders don't use male condoms consistently. Receptive sex partners deserve and need more forms of protection.
- Condoms are multi-purpose protection from pregnancy, HIV and other STIs. People who need that kind of protection have no alternatives if male condoms are not acceptable and female condoms are not available and affordable.
- Pre-exposure prophylaxis (PrEP) is not for everyone. And given that women have to take PrEP more consistently and for a longer time to achieve protective drug levels, even women using PrEP may need additional protection when they start using PrEP or if they do not use it consistently.
- Access to PrEP and most contraceptive methods requires a prescription. All condoms are available over the counter, but female condoms are sometimes hard to find. While FC2 commercial access is expanding to include placement in more brick and mortar stores and online retail outlets, they are not reliably available in many regions. Lower cost and better promotion could fix that.
The National Female Condom Coalition (NFCC) launched a campaign, called "Imagine the Future of Female Condoms" to urge the FDA to implement this down-classification. While building grassroots domestic demand for this change, NFCC is also informing and engaging global advocates -- including HIV-focused, reproductive justice and family planning organizations -- and has met and talked directly with decision makers in the appropriate FDA branches on multiple occasions.
The slow pace of the FDA's review is allowing time for public advocacy to build. Nearly 100 organizations support down-classifying the female condom. Lend your support. Sign the petition, and check out other NFCC activities.
Without this change, female condoms will remain -- for most people and especially for women living in in poverty -- one more nice thing that other people get to have. That's not the case with male condoms. Let's bring the price of female condoms down and create a little more HIV prevention equality for receptive sex partners.
Anna Forbes is a Washington, D.C.-based writer, organizer and activist working in HIV/AIDS since 1985. Now an independent consultant focused on women's needs in regard to HIV, her current and recent clients include the Sero Project, SisterLove, GNP+, the Positive Women's Network - USA, the International AIDS Society, IAVI, UN Women and the Global Network of Sex Work Projects.
Jessica Terlikowski is director of prevention technology education at AIDS Foundation of Chicago.