The Female Health Company today announced approval from the U.S. Food and Drug Administration for the company's FC2 Female Condom, a woman-initiated barrier method that helps to protect against sexually transmitted diseases, HIV, and unintended pregnancy.

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FHC's lower-cost, second-generation female condom will now be available for purchase and distribution in the United States. The FDA approval also will enable the United States Agency for International Development to procure FC2 condoms for distribution to global HIV prevention programs.

The data on changing patterns in the incidence and prevalence of HIV and other STDs and the rates of unintended pregnancy suggest that there is an unmet need for women-initiated prevention methods. Unintended pregnancy and HIV infection are significant public health challenges in the United States. The most recent data from the Centers for Disease Control and Prevention indicate that one half of U.S. pregnancies are unintended, and one in four young people aged 15–20 contracts an STD each year.

The proportion of women among people living with HIV and AIDS in the United States also has tripled over the past two decades -- from 8% in 1985 to 26% in 2007. High-risk heterosexual contact is responsible for 80% of new HIV infections among American women.

HIV is more prevalent among African-American and Hispanic women. According to the CDC, the AIDS case rate in 2004 was 23 times higher among African-American women and five times higher among Hispanic women than among white women.

"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," said Mary Ann Leeper, FHC's senior strategic adviser. "Today's 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."

FHC's first-generation FC female condom (FC1) originally received FDA approval for distribution in the United States in 1993. FC1 also is included in the World Health Organization's essential products list for distribution by United Nations 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 United States 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.

This cost factor has reduced public access to the only safe and effective woman-initiated method of HIV and STD prevention developed since the start of the global AIDS pandemic. Approximately 10 billion male condoms were distributed throughout the global public sector in 2008, compared to about 35 million female condoms distributed during the same period. This suggests a remarkable opportunity for the female condom to strengthen access to HIV prevention tools through increased access to the only woman-initiated prevention method.

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 STDs 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% 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.

"Research has shown that the female condom can strengthen HIV prevention by providing men and women with access to more prevention options," said Leeper. "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 STD infections declined significantly as compared to when only male condoms were available. FC female condoms put the power of protection in women's hands."

Data on FC2 have been reviewed and approved by other regulatory agencies, including the European Union, the WHO, and agencies in India and Brazil. In 2006, the WHO, based on its own review of the scientific data, agreed that FC2 performs in the same manner as FC1 and cleared FC2 for purchase by U.N. agencies. Since then, more than 23 million FC2 female condoms have been distributed in 77 countries. The FDA approval of FC2 will allow USAID to procure the second-generation female condom at a lower unit cost for U.S.-funded prevention programs around the world.