Veru Health, the manufacturer of the only internal condom approved by the Food and Drug Administration, has made the decision to start selling internal condoms — more commonly known as female condoms — as prescription-only.
Though the internal condom (named F2C by the manufacturer) is currently only FDA-approved for vaginal use, many men and women also use it during anal sex to help prevent sexually transmitted infections, including HIV. The F2C provides protection against pregnancy and STIs by preventing the exchange of bodily fluids and blocking some skin-to-skin contact.
The decision came after a recent merger between Veru Health (formerly Female Health Company) and Aspen Park Pharmaceuticals. Very poor retail sales of the F2C are the main reason for the change, explained Veru’s chief commercial officer, Brian Groch, to TheBody.com. According to Groch, the device just wasn’t selling in retail settings, and most people who use the product get it for free or heavily discounted at public health organizations, such as local clinics. Groch said that continuing to invest in the retail sales model was simply unsustainable, therefore the company decided to move to a prescription distribution model instead.
Though there has not been much research done on the internal condom’s use for STI protection, there is some data to support Groch’s claim of low sales. As few as 0.3 percent of women using contraception in the U.S. use this device as their main form of birth control, according to the Center for Disease Control and Prevention’s National Health Statistics Reports. A lack of awareness and education about F2C is also a major contributing factor in its unpopularity.
Under the new prescription model, the F2C should be covered by insurers at no cost because it is named as one of the 18 methods listed in the Affordable Care Act’s (ACA or Obamacare) birth control mandate. In a perfect world, this would mean that anyone with insurance could obtain F2C for free at just about any pharmacy.
Unfortunately, this isn’t a perfect world, and Obamacare is now under attack by the Trump Administration, which is currently working hard to “repeal and replace” it. Another problem is that for those who are uninsured, the price would go from about $3.50 per device to approximately $20 per device. Groch argues that uninsured folks will still be able to access F2C at free clinics since Veru health will continue to supply it to public health organizations.
Regardless, advocates of F2C are worried about accessibility for those who need it most, and say that the timing couldn’t be worse. "The decision is particularly staggering given that that Affordable Care Act, Medicaid and family planning programs are on the chopping block. If Republicans get their way, these programs will be gutted leaving the only receptive partner-initiated barrier method out of reach for people living with and vulnerable to HIV," said Jessica Terlikowski, of the Chicago AIDS Foundation, to TheBody.com.