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FDA Approves Lower-cost Female Condom
Earlier this week, the Female Health Company (FHC) announced approval from the US Food and Drug Administration (FDA) for the company's Female Condom (FC2), a woman-initiated barrier method that helps to protect against sexually transmitted infections (STIs), HIV/AIDS, and unintended pregnancy.
FHC's lower-cost second generation female condom will now be sold at 30 per cent less than the earlier version of female condom.
FHC's first-generation 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.
With microbicides still in different stages of the research pipeline, the female condom is currently the only method available to prevent HIV infection and unintended pregnancy that is designed for women's initiation. FDA approval of the FC2 is significant since the new product will sell for about 30% less than its predecessor, the FC1.
Female condoms have been relatively expensive in many parts of the world, due to a constellation of factors including manufacturing costs, bulk purchasing, and government and donor investment. Reduction in manufacturing costs, therefore, is one of many important avenues for making the new female condom more affordable and accessible to women and men in the US and internationally.
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.
FHC's lower-cost second generation female condom will now be sold at 30 per cent less than the earlier version of female condom.
FHC's first-generation 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.
With microbicides still in different stages of the research pipeline, the female condom is currently the only method available to prevent HIV infection and unintended pregnancy that is designed for women's initiation. FDA approval of the FC2 is significant since the new product will sell for about 30% less than its predecessor, the FC1.
Female condoms have been relatively expensive in many parts of the world, due to a constellation of factors including manufacturing costs, bulk purchasing, and government and donor investment. Reduction in manufacturing costs, therefore, is one of many important avenues for making the new female condom more affordable and accessible to women and men in the US and internationally.
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.
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More News on: Gonorrhea, Condoms And Contraception, Syphilis, AIDS/HIV - Prevention And Transmission, Vasectomy, Chlamydia Trachomatis, Prostitution: Fresh Stakes in the Oldest Trade, Safe Sex
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