It’s time to end the female condom monopoly in the US!
Two and a half years have passed since the U.S. Food and Drug Administration (FDA) answered the call of advocates and announced it would consider down-classifying female/internal condoms. While the decision was a critical first step to removing unnecessary barriers to bringing new safe and effective products to market, the FDA has failed to publicly demonstrate any additional movement since its 2015 announcement. Given that the FC2 manufacturer, Veru, decided this year to stop selling the FC2 over the counter and, instead, prioritize profits over people’s health, it’s more urgent than ever to end the female condom monopoly in the U.S.
Background: Since approved by the FDA in 1993, the female condom has shared the same classification as breast implants and pacemakers, Class III. Male condoms enjoy a Class II status. The more stringent classification made sense when the product was new and data was limited. However, we now have quality standards and more than 20 years of safety and efficacy data to support making female/internal condoms a Class II device.
Why down-classification matters: In addition to reflecting the latest evidence on female condom safety and efficacy, making internal condoms a Class II device would: help bring safe and effective female condoms already available in other countries to the U.S.; encourage product innovation among condom developers; put female condoms in the same medical device category as male condoms; and align U.S. regulations with other global health regulatory agencies.