For Immediate Release
WASHINGTON, D.C. - MARCH 24, 2009 - The U.S. Agency for International Development (USAID) has announced that the U.S. Food and Drug Administration (FDA) has approved use of the FC2 Female Condom® (FC2) made by the Female Health Company (FHC). FC2 is a woman-initiated barrier method that helps protect against sexually transmitted infections, HIV/AIDS, and unintended pregnancy. Its design and method of use is similar to its predecessor - FC1 - and studies have shown that FC2 performs in a comparable manner to FC1 in terms of safety, failure rates and acceptability.
The second generation female condom FC2 is made of a synthetic latex. It consists of a soft, loose fitting sheath, a rolled outer ring made of nitrile polymer and one flexible inner ring made of polyurethane and other materials. The nitrile polymer allows FC2 to be produced more economically than FC1. FC2 will also cost distributors about 33 percent less than FC1, depending on the volume of purchases. Like the FC1, the approved label for the FC2 is not reusable.
The FDA approval of FC2 will allow USAID to procure the second-generation female condom at a lower unit cost for U.S.-supported HIV/AIDS prevention and family planning programs around the world.
FC2 is currently available in 77 countries, and is produced at FHC's facilities in Malaysia and India.
The USAID | DELIVER PROJECT is preparing a new contract to purchase this product on behalf of USAID. All pending orders in the system for FC1 will be filled until the new FC2 contract is in place. All new orders will be filled with FC2 once the contract is awarded with FHC and registration/importation requirements in the countries where USAID works have been secured.
USAID has long recognized the importance of the female condom and the role it plays in sexual and reproductive health programs worldwide. The Agency has been a committed purchaser of the female condom, and its missions have worked to introduce and integrate the female condom at the country level.
For more information about USAID and its family planning programs, please visit: www.usaid.gov.
Last updated: May 31, 2012