Overcoming Regulatory Barriers to Increase Female Condom Access
Three guest bloggers have contributed to this posting — PATH staff members Kimberly Whipkey, Policy and Advocacy Officer, and Maggie Kilbourne-Brook, Senior Program Officer, along with Sara Semelka, Program Manager, AIDS Foundation of Chicago/National Female Condom Coalition
One small rule change being considered by the U.S. Food and Drug Administration (FDA) could make a big difference in the pregnancy and HIV prevention worlds—and expand female condom options available to women, men, and young people.
The female condom is a valuable prevention tool that should be offered as part of a wide method mix. It is the only option available today that protects from both unintended pregnancy and sexually transmitted infections (STIs) and is designed for women and receptive partners to initiate.
Following years of advocacy led by the National Female Condom Coalition (NFCC), female condom researchers, and civil society groups across the world, the FDA recently issued a proposed rule to reclassify the female condom from a Class III medical device to Class II. Why is this so important? The change in classification would make it much easier for female condom manufacturers to seek USFDA approval, which could potentially result in additional female condom products on the US market. And, if additional female condoms receive US market clearance, this approval may help facilitate product registrations and increase access in other countries.
With the growing body of evidence generated over the past few decades from clinical studies and consumer use, practitioners, researchers, and advocates increasingly have questioned the need for the Class III designation. The FDA categorizes medical devices into one of three classes—Class I, II, or III—based on their risks and the regulatory controls needed to assure safety and effectiveness. A Class III device requires the greatest amount of clinical evidence and control.
When the FDA evaluated the first female condom in 1991—the Female Health Company’s FC1—it gave female condoms a Class III designation. This was because the FDA determined that the female condom was not substantially equivalent to the male condom (it works differently from the male condom and has different ways of failing during use, known as “failure modes”), so there were no safety and effectiveness data from a previously approved and marketed device. Class III medical devices “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.” Examples include implantable pacemakers and breast implants—products that have a lot more potential risk to human health than female condoms.
This Class III designation means that female condom manufacturers must meet the FDA’s most stringent requirements for documentation and clinical evidence of safety and effectiveness. In practical terms, this means that manufacturers considering a Class III premarket approval application face a process that is very costly in terms of time, money, and level of evidence required. The Class III designation has deterred some female condom manufacturers from pursuing FDA approval for their products. In contrast, the male condom is categorized as a Class II medical device, because when this was decided in 1981, the FDA determined sufficient evidence on safety and effectiveness existed.
Since the USFDA’s initial approval of the FC1 and its subsequent review and approval of the FC2 in 2009, additional female condom products have been developed, have achieved regulatory approvals and prequalification by the World Health Organization, and are being marketed in other countries (new types of female condoms include the Cupid®1, Velvet, and Woman’s Condom, among others).
Numerous clinical studies, and more than 25 years of experience and use of female condoms, confirm their safety and effectiveness. Female condoms have been well studied as a category of products, and their failure modes are well defined and can be evaluated.Advocates used this evidence to urge the USFDA to “down-classify” female condoms. We shared evidence, cultivated internal champions, mobilized domestic and international support through petitions, and persisted in engaging the DA.
A window of opportunity opened in 2015 when the USFDA announced that it was conducting a retrospective review of all Class III products to assess their appropriateness for that designation. The NFCC promptly launched a campaign for the FDA to prioritize review of female condoms. More than 100 organizations signed a letter to the FDA in 2016, urging its support for reclassification on the rationale that this would more accurately reflect current scientific evidence regarding female condom safety, performance, and efficacy.
These advocacy efforts culminated in the FDA’s release of its proposed rule on December 4, 2017. In addition to reclassifying the “single-use” female condom from Class III to Class II, the proposed rule seeks to rename single-use female condoms to single-use “internal condoms.” This change in naming is also a huge victory in de-gendering the device, because people of all genders and sexualities use the product for vaginal and/or anal protection.
While the notice of the proposed rule change is an important step, the FDA’s proposed rule also suggests it may still require significant clinical data for female condoms from both a contraceptive effectiveness study and a failure modes study. If so, this is a higher requirement for clinical data than is required for male condoms from manufacturers seeking regulatory approval through the 510(k) process. We advocate that as possible, female condoms should be evaluated for safety and effectiveness based on a clinical study of failures, similar to how male condoms are evaluated.
The FDA is seeking public comments on its proposed rule until February 2, 2018. The NFCC has developed an international sign-on letter expressing its support for the rule change. The road to female condom reclassification has been a long one, and it’s not over yet. Over the coming months, advocates will be following closely to see whether the FDA moves from proposed rule to reality.