FDA Approves FC2 Female Condom

Laurie Barclay, MD

March 18, 2009

March 18, 2009 — On March 11, the Female Health Company (FHC) announced that their FC2 female condom was approved by the US Food and Drug Administration, with the expectation that this lower-cost, second-generation female condom would improve access to woman-initiated protection against HIV/AIDS, sexually transmitted infections (STIs), and unintended pregnancy.

In addition to being available for purchase and distribution in the United States, FC2 will now be available to the US Agency for International Development for distribution to global HIV/AIDS programs.

"Nearly three decades after the start of the global AIDS pandemic, FHC's female condoms remain the only safe and effective woman-initiated HIV prevention method approved by the FDA," Dr. Mary Ann Leeper, FHC's senior strategic advisor, said in a news release. "Approval of FC2 — a lower-cost, second-generation female condom — is an important development in efforts to deliver affordable access to woman-initiated HIV prevention in the United States and around the world."

In 1993, the FDA approved FHC's first-generation FC Female Condom (FC1). Since then, 165 million FC1 female condoms have been distributed in 142 countries, and studies have shown that acceptability of FC1 is comparable to that of the male condom for both men and women. However, the high cost of FC1 has hindered increased use by US and global HIV prevention programs.

Five years ago, FHC began engineering FC2 to be less expensive by using a new material and a different manufacturing process. Whereas FC1 is made from polyurethane in a labor-intensive manufacturing process, FC2 is made from a proprietary nitrile polymer using a highly automated process. Initial cost of FC2 for global procurement programs will be 30% less than that of FC1, and as public sector volume increases, additional cost reductions may be possible.

Research to date indicates that performance of FC2 is comparable to that of FC1. In a randomized, double-blind, crossover, comparative trial of FC2 with FC1, performed in 2004 by the Reproductive Health and HIV Research Unit of the University of Witwatersrand in South Africa, findings from more than 200 women were that FC2 is safe and that failure risk during use was similar to that of FC1 (Contraception. 2006;73:386–393).

"Research has shown that the Female Condom can strengthen HIV prevention by providing men and women with access to more prevention options," Dr. Leeper said. "In studies where the FC Female Condom is distributed by prevention programs together with the male condom, the rate of unsafe sex acts decreased and the rate of new [STIs] declined significantly as compared to when only male condoms were available."

The European Union, the World Health Organization (WHO), and agencies in India and Brazil have also approved this product. Since WHO cleared FC2 for purchase by UN agencies in 2006, more than 23 million FC2 Female Condoms have been distributed in 77 countries.

FHC hopes that FC2 will help address the unmet need for women-initiated prevention methods for HIV/AIDS, other STIs, and rates of unintended pregnancy, which continue to be significant public health challenges in the United States. According to the Centers for Disease Control and Prevention, one half of US pregnancies are unintended, 1 in 4 people aged 15 to 20 years contracts an STI each year, and the proportion of women among people living with HIV/AIDS in the United States has tripled during the past 2 decades, from 8% in 1985 to 26% in 2007.

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