In June, Veru Healthcare, the manufacturer of the female condom, changed how consumers can access its product. It is no longer available for purchase on drugstore shelves but can now be obtained through a pharmacist with a prescription or ordered directly from the company online.

Earlier this week, a coalition of more than 200 advocates sent a letter urging the company to reverse its decision and arguing that these changes make an important prevention tool harder to get and significantly more expensive. The company disagrees, saying its new distribution methods give people more options and should even make it cheaper for most people.

While it is not surprising that a for-profit company and a coalition of health departments, community-based organizations, and national nonprofits would see the world slightly differently, the level of disagreement—even over simple facts—is a bit alarming.

A Little-Used Prevention Method

The female condom is a sheath that is closed at one end and has ringlike opening at the other. A second flexible ring goes inside the condom so that it can be inserted into the vagina and stay in place. Like the male condom, the female condom protects against sexually transmitted infections (STIs) and pregnancy by creating a barrier that blocks the exchange of bodily fluids and prevents some direct skin-to-skin contact. Though only approved for vaginal use, research shows that both men and women use the female condom for protection during anal sex.

This is the only barrier method for STI prevention that is controlled by the receptive partner, and it is the receptive partner who is at greater risk for contracting STIs and HIV. Despite this, the female condom has never been very popular in the United States. According to the National Health Statistics Reports, less than 0.3 percent of women using contraception rely on it as their primary method of birth control. In contrast, 10 percent say they are using male condoms and 17 percent rely on the pill.

Some of its unpopularity may be a result of its price tag; it has always been significantly more expensive than a male condom. Some users also complained that the baggy design of the product made it cumbersome, and the original version was known to be noisy during intercourse.

In 2006, a new version was released, and it was made from the synthetic rubber nitrile instead of polyurethane, a common material for condoms. Called FC2, this second-generation female condom is just as effective as the original but less expensive to produce and apparently not squeaky during sex.

Access to FC2: Then and Now

Both activists and the company agree that most people in the United States who use FC2 get the product from a health department or community-based organization. What they can’t seem to agree on is how important retail sales were or could be to overall access.

Until recently, at least in theory, someone who wanted a FC2 could walk into their local Walgreens or CVS and grab a box of three off the shelf. They could walk out having spent between $10 and $12 or roughly $3.50 a condom.

However, most drugstores did not stock the item. Walgreens, for example, has more than 8,000 stores in the United States and maybe 400 of them stocked the product, according to Brian Groch, the chief commercial officer at Veru. Moreover, Groch said that those stores that had them on shelves didn’t sell them. He told Rewire a story of walking into a Duane Reade in New York City and finding a bunch of boxes of FC2 in the half-off bin.

Poor sales led to the company’s decision to discontinue its retail distribution in favor of a plan that focuses on health-care practitioners and prescription distribution. This puts the product behind the pharmacy counter but means that it should be covered by insurance; the female condom is one of 18 methods of contraception available at no cost to consumers under the Affordable Care Act (ACA) birth control mandate. On Friday, however, the Trump administration released new rules that allow employers to skirt that mandate, effectively putting no-cost contraception at risk for thousands of women.

For now, a person who has insurance can walk into their local drugstore and get the product for free, but they have to have seen their provider for a prescription first.

Advocates say this system, by its very nature, limits access to those who can see health-care providers or have insurance. In the letter to Veru Healthcare, the Female Condom Coalition writes: “We are concerned that requiring a clinician gatekeeper will substantially reduce access for all, including individuals with low incomes and poor access to quality health coverage and care.”

Veru thinks it may have solved one of these issues since the coalition sent its letter. Groch recently told Rewire that the company had teamed up with a telemedicine app called HeyDoc!. A virtual visit will cost $5 and from it a person can get a prescription for a box of 24 with one refill. That ends up being 48 condoms for $5 or 10 cents per condom.

Amanda Jean Stevenson, a sociology professor at the University of Colorado who studies contraception access, told Rewire that a middle ground might have been to work on allowing pharmacists to actually write the prescriptions through what’s called collaborative practice agreements. Pharmacies partner with physicians or nurse practitioners to be able to write prescriptions for patients who come into the pharmacy without one. Some states allowed this practices for emergency contraception before it went over the counter, and others allow it now for hormonal contraceptive methods like the birth control pill.

Even without this, Stevenson says there is no clear winner or loser in the change to FC2 access for people interested in birth control. “Making it available by prescription only will increase access for some people and decrease it for others,” she said.

The one who might be hit hardest, though, are men who have sex with men using FC2 as a method of STI protection. Stevenson explained that the ACA contraceptive benefit only covers female-controlled birth control, hence the male condom is not one of the methods included. It is possible that a man can have a prescription covered for the female condom with the implicit—if perhaps inaccurate—understanding by the insurance company that it is being used for vaginal sex. In fact, Groch says he tested the system and was able to fill a prescription in his own name for no cost.

But again, this is limited to those who have insurance and is based on the ACA’s contraception benefit, which is not politically secure. President Trump’s Department of Health and Human Services gutted the no-cost contraception benefit Friday by allowing many employers to deny coverage of contraception in their health insurance plans, and Republicans in Congress will likely try wholesale repeal of the ACA again. It is unclear how much FC2 would be with a prescription in a post-ACA world.

The Price of Protection

There is even a debate over how much the product costs right now if someone who did not have insurance were to ask their pharmacist for it. In its letter, the coalition claims that with the change to a prescription model, the price went from between $2 and $3 a condom to upward of $10 a condom. Groch uses a distributor to sell FC2 to pharmacies, and he’s not sure how much the product would cost an uninsured patient in a pharmacy. But he believes that this is irrelevant because there are so many other ways that people who don’t have insurance can access FC2.

The company says it is still committed to selling the product at a deep discount to health departments and community-based organizations, and it will also start participating in the federal 340B pricing program, which makes FC2 available at a discounted cost to college health centers, Ryan White HIV and AIDS clinics, and Title X family planning clinics. Until now, the company used distributors to sell FC2 to these agencies so Groch said that he was not sure how much these agencies actually paid per condom.

Rewire spoke to a representative from one of these distributors who said that prices varied a lot but put the average price at 82 cents per condom. The company is cutting out these distributors and starting to sell directly to public health institutions. While the price may still vary, Groch expects them to sell for “well under $1 a unit.” However, sales to public health entities are on back order while the product is repackaged. In an email, Groch said, “We should have product available to meet all demand by the end of this year.”

The company has also added a direct-to-consumer sales avenue that allows people to request up to 24 condoms a month. The company charges $19.95 for a pack of 12 with about $10 of shipping and handling fees. This ends up being between $2.08 and $2.50 a condom depending on whether you order one or two boxes (the shipping fee does not increase for the second box). Groch notes those expenses are less than it used to cost over-the-counter in a pharmacy.

But the coalition called this program “woefully insufficient” because it’s limited to people who have internet access, a debit or credit card, and an address at which they can receive packages. The letter calls on Veru to lower the price of the product saying, “If Veru is truly committed to expanding access to HIV-vulnerable people in the United States and prioritizing the public’s health, it must recognize that selling more of a deeply discounted product is better than selling none of a higher-priced product.”

Again, Groch disagrees that the price went up in anything but the hypothetical situation of the uninsured person who tries to buy it at a pharmacy. He says that the weighted average cost of the product across all avenues of sales is $1.48 per condom. And, he says, “We’re not getting rich at $1.48 a condom.”

Promoting an Unpopular Product

The real question is whether these new changes have decreased access to this important prevention tool. Not surprisingly, Groch says that it hasn’t: “Nothing has changed. We’re not decreasing access. If they don’t have insurance, they come to us to get it. We added online sales.”

Advocates, however, remain very concerned that the product isn’t in pharmacy aisles anymore even if few people accessed it that way. The letter argues: “Pulling FC2s off the shelves and putting them behind a gatekeeper further hinders people’s awareness and understanding of the product and creates an unnecessary waiting period for FC2.” They argue that the answer was not to stop selling it over-the-counter but to make a concerted effort to increase sales.

Jessica Terlikowski, senior director of advocacy and community mobilization at AIDS Foundation of Chicago (which spearheads the National Female Condom Coalition), told Rewire: “The company has never invested in community education, social marketing, and provider engagement in a meaningful way. And that’s one piece of why so few people were buying it.” In the past, she says, advocacy groups have run campaigns in cities like New York and Los Angeles promoting the female condom with success, but the company itself never tried to reach its consumer.

Stevenson says it takes a lot to get someone to change their current method of contraception and that, barring some change in their personal situation, a new method needs to offer something the old one did not. That’s a tall order for the female condom whose biggest selling points are that it can be female-controlled and protects against STIs. “Almost all methods are female-controlled,” Stevenson noted, “and STI protection is not the primary thing most people care about when they choose a method.”

Moreover, large-scale marketing and advertising campaigns are not cheap, and Groch is honest about not being able to afford them: “We’re limited in what we can do because we just don’t have the resources.” Veru Healthcare is not necessarily ‘Big Pharma.’” It is a new company formed by the merger of the Female Health Company (which was formed in 1995 to sell just this product) and Aspen Park Pharmaceuticals. At the time of the merger, FC2 was its only profit-making product. And the female condom has not always been profitable: The Female Health Company operated at a loss for its first ten years.

Though Veru is doing some work directly with students on college campuses (which can receive FC2 from the company through its 340B pricing program), Groch and his team are mostly reaching out to providers instead of consumers. They say this approach is more economical, and their hope is that educated providers will then inform their patients and write prescriptions.

But Terlikowski does not think this will be enough. “It’s clear that we have a fundamental disagreement about what it takes to get prevention options to people to need them. They think they’ll increase access by going through clinical providers. We think that’s an important piece—we would love to see more providers promote this method—but we’ve been doing that for a long time. Just relying on them is not going to meet the needs of those that are most at risk of HIV.”

Fundamental Agreement

Through all these arguments, there is one thing that the activists and the company really do agree on: The female condom is an important product that more people should use. Both Groch and Terlikowski pointed Rewire to research that found that when both female and male condoms were made available, the number of protected sex acts went up and that when given multiple opportunities to try female condoms both men and women like the product sometimes even more than male condoms. Both of them also said other countries did a better job of educating providers and consumers about female condoms. South Africa, for example, invested in a long-running national campaign to promote female condom use as HIV-prevention tool. An evaluation after almost 20 years found that 90 percent of the population had heard of the method though still only 20 percent had used one.

There is a long tradition of private companies working with nonprofit or governmental organization to achieve public health goals regarding contraception. Stevenson, the University of Colorado sociology professor, pointed out that many of our current methods of contraception were created under one of these partnerships.

Unfortunately, she says what often happens is that the company who produces the product takes the reins once it hits the market and makes huge profits off of something they didn’t produce by themselves.

Stevenson explained: “The IUD was developed this way and now companies are selling this method, which cost pennies to produce for $800 even though they didn’t put any money into developing it.” The situation with the female condom is not the same, but Stevenson drew the parallel because as she puts it, the real problem remains: “How do we deliver health care within a capitalist system? We don’t have a perfect solution for that.”

The balance is tricky. Female condoms fulfill a public health need, and people should have unfettered access to them. But if the company goes out of business trying to sell an unpopular product, no one can have it. In the end, this seems like a missed opportunity for advocates and industry to work together. Veru angered advocates by making these changes without any advance notice or consultation. And advocates may be antagonizing the company by making demands that it simply can’t afford to honor.

Though working together might be difficult, collaboration clearly has the potential to get more accomplished. And despite almost 25 years on the market in this country, the female condom is still all about unmet potential.