FDA approves FC2 female condom

Mar 16 2009

The Female Health Company on Wednesday announced that FDA has approved its FC2 Female Condom to help prevent pregnancy and sexually transmitted infections such as HIV, the AP/Forbes reports.

With the approval, the lower-cost, new version of the female condom now will be available in the U.S. In addition, USAID now can procure the condoms and distribute them through HIV/AIDS programs worldwide (AP/Forbes, 3/11).

The new female condom is made of synthetic rubber instead of polyurethane and is less expensive than the original version. According to the Chicago Tribune's "Triage," both the new version and older version are equally effective. The new version likely will cost about 30% less than the older version, making it more affordable for individuals and public health groups, Mary Ann Leeper, strategic adviser to FHC, said (Graham, "Triage," Chicago Tribune, 3/11). The new version also is manufactured through a less-expensive process, which FHC said should allow health groups to distribute larger quantities to women in Africa and other areas heavily affected by HIV/AIDS. The FDA approval is an "important development in efforts to deliver affordable access to woman-initiated HIV prevention in the United States and around the world," Leeper said (Reuters India, 3/11).

The World Health Organization in 2006 approved the new version of the female condom for purchase by United Nations agencies, according to FHC. More than 23 million FC2 condoms have been distributed in 77 countries since then (AP/Forbes, 3/11).