AEGiS-PRn: U.S. Food and Drug Administration Approves New Female Condom: Center for Health and Gender Equity Applauds Expansion of HIV Prevention Options for Women and Men Worldwide

Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.

U.S. Food and Drug Administration Approves New Female Condom: Center for Health and Gender Equity Applauds Expansion of HIV Prevention Options for Women and Men Worldwide

PRNewswire - March 11, 2009

WASHINGTON, March 11 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration (FDA) granted regulatory approval to the FC2 female condom, a lower-cost, second generation product manufactured by the Female Health Company -- a move widely praised by HIV/AIDS and women's health and rights advocates globally.

"We join women around the world in applauding the FDA's swift action to approve the FC2 female condom," stated Serra Sippel, executive director of the Center for Health and Gender Equity. "The HIV pandemic among women requires increased investment in woman-centered prevention options, and FC2 approval is an important step forward in putting the power of prevention in women's hands."

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 U.S. and internationally.

Advocates are now calling on the U.S. government to react quickly to ensure rapid expansion of female condom distribution and programming, and have support from U.S. law. In the reauthorization legislation for the President's Emergency Plan for AIDS Relief (PEPFAR) in 2008, Congress explicitly mentioned female and male condoms, emphasizing the importance of increasing availability and access to these commodities and ensuring consistent and correct use as essential for HIV/AIDS prevention efforts.

"We praise Congress for including specific references to female condoms, as both male and female condoms are safe and effective HIV prevention tools that are available to women and men today. We now look to the next leader of the Office of the Global AIDS Coordinator to ensure that female condoms are truly available, accessible and well-programmed for women and men worldwide," said Serra Sippel.

The United States Agency for International Development (USAID) plans to phase out procurement of the FC1 upon FDA approval of the FC2, according to Saving Lives Now, a report by the Center for Health and Gender Equity. This means that potentially more female condoms can be procured, distributed and programmed overseas due to lower costs.

"Female condoms are a vital tool for prevention, women's empowerment and communication between partners, and in Zimbabwe, we greatly welcome this decision by the U.S. FDA," said Edinah Masiyiwa, executive director of Women's Action Group (WAG) - Zimbabwe. "Women and men alike benefit from the female condom, with regard to their health, happiness and pleasure."

The FC2 has the same design, appearance and use as the FC1, but is made of a different material -- a synthetic rubber called nitrile. The FC2 holds all the benefits of the FC1 and is comparable in safety and effectiveness. Despite their many benefits, female condoms account for only 0.2% of the world's total condom supply and make up only 1.6% of U.S. international condom shipments. It is unclear how long it will take before the FC2 is distributed through U.S.-funded HIV prevention programs overseas.

Source: Center for Health & Gender Equity (CHANGE)

CONTACT: Serra Sippel of Center for Health & Gender Equity (CHANGE), +1-202-393-5930, Mobile: +1-202-631-8808, ssippel@genderhealth.org

090311
PR090317

Copyright © 2009 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.

Always watch for outdated information. This article first appeared in 2009. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2009. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .