The FDA has given approval to the Female Health Company, out of Chicago, Illinois, to market the new FC2 female condom. The FC2 is made out of nitrile, a synthetic rubber compound, and promises considerable savings over previous female condoms.
FHC’s first-generation FC Female Condom® (FC1) originally received FDA approval for distribution in the United States in 1993. FC1 is also included in the World Health Organization’s (WHO) essential products list for distribution by United Nations (UN) agencies. Since its approval, 165 million FC1 female condoms have been distributed in 142 countries.
The cost of FC1 has remained a key barrier to increased uptake by HIV prevention programs in the U.S. and globally. While numerous studies over the past two decades have indicated that acceptability of FC1 is comparable to the male condom among both male and female users, the high cost of FC1 has limited procurement by government programs and direct purchase by individual consumers.
As a result, five years ago FHC initiated the development of the FC2 Female Condom to expand access to women at risk of HIV and STIs by significantly lowering the cost of the product. FHC has succeeded in reducing FC2’s cost through the introduction of a new material and a different manufacturing process. FC1 is made from polyurethane and involves a labor-intensive manufacturing process, while FC2, which looks very similar to FC1, is made from a proprietary nitrile polymer that allows it to be manufactured using a highly automated process. Studies have shown that FC2 performs in a comparable manner to FC1.
As a result of FHC’s development program, FC2 will be available to the public sector at a cost as much as 30 percent less than FC1, contingent on volumes of procurement. In addition, the company has indicated that as public sector volume increases, additional cost reductions may be possible.
Press release: Female Health Company Receives FDA Approval for FC2 Female Condom (PDF)
Product brochure (PDF)…
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