For Immediate Release
Serra Sippel, Center for Health and Gender Equity, 202.393.5930 (o), 202.631.8808 (m)
Jessica Terlikowski, AIDS Foundation of Chicago, 312.334.0931 (o)
Domestic and International HIV/AIDS and Reproductive Health Organizations Unite to Support Female Condoms at U.S. FDA Review
WASHINGTON - Today, 170 domestic and international organizations committed to
women's sexual and reproductive health and human rights called on the
Obstetrics and Gynecology Devices Advisory Committee at the U.S. Food
and Drug Administration (FDA) to recognize the importance of female
condoms as the committee deliberates over granting premarket approval
to the FC2--the second generation of the Female Health Company's female
condom. The diverse group of organizations submitted a joint statement
to the advisory committee members underscoring the critical value of
female condoms for women's health and rights, as female condoms are the
only existing tool designed for women's initiation that prevents HIV
In the letter, organizations
highlight that women--who comprised half of the 33.2 million people
worldwide with HIV/AIDS in 2007--desperately need access to female
condoms and education on their use in order to stay healthy, plan
family size and protect themselves and their partners from HIV.
Despite this urgent need, female condoms remain out of women's hands in
many places globally, due to factors such as lack of political will and
donor investment. As the organizations state in the letter, "[W]ith
sustainable procurement and distribution and effective programming, the
FC2 has great promise for getting into the hands of women worldwide and
ultimately saving lives."
committee's decision on FC2 pre-market approval can have an enormous
impact on the availability and accessibility of female condoms for
women in the U.S. and across the world," said Jessica Terlikowski,
Policy Manager at the AIDS Foundation of Chicago. "We're hoping the
committee sends a strong signal to the FDA--and to the world--that we
must prioritize safe, effective and affordable prevention methods for
women, like the FC2."
The FC2 is
already being procured by international bodies like the United Nations
Population Fund (UNFPA). In 2006, the World Health Organization (WHO)
concluded that the FC2 is acceptable for bulk purchase. And, according
to a report by the Center for Health and Gender Equity, the United
States Agency for International Development (USAID) plans to phase out
procurement of the FC1 if the FDA review results in approval of FC2.
and reproductive health and rights advocates across the world will have
their eyes on the FDA today," stated Serra Sippel, Executive Director
of the Center for Health and Gender Equity. "The U.S. has an important
opportunity to provide leadership in expanding HIV prevention options
The advisory committee
decision also has significant implications for female condom education
and distribution in the United States. HIV/AIDS and reproductive
health organizations are excited by the prospect of adding a new,
woman-centered prevention tool into their programming.
are strong advocates of the female condom and include them in our
prevention education around barrier methods. It's incredible to see
the positive reactions from women when they learn that they, too, have
an option for initiating HIV prevention and safe sex. The more
opportunities and options women have for taking prevention into their
own hands, the better," said Shayne Galloway, Prevention Program
Director at Vermont CARES, a local AIDS Service Organization.
Obstetrics and Gynecology Devices Advisory Committee will vote by the
end of the day whether to recommend pre-market approval for the FC2.
The FDA will take the committee's decision into consideration when
making final deliberations about approving the product, which is likely
to occur within the next few months.
The organizational statement can be accessed at: http://www.preventionnow.net/
For more information about female condoms and advocacy, and to download
the Center for Health and Gender Equity's report Saving Lives Now: Female Condoms and the Role of U.S. Foreign Aid, please visit www.preventionnow.net.
Prevention Now!--an initiative of the Center for Health and Gender
Equity--is a global campaign to ensure that governments and donor
agencies provide funding to dramatically increase access to female
condoms and other existing prevention options for women and men, to
prevent the spread of HIV, reduce unintended pregnancy, and advance the
sexual and reproductive health and rights of all people worldwide.
he Center for Health and Gender Equity (CHANGE) is a U.S.-based non-governmental organization that seeks to ensure that U.S. international policies and programs promote sexual and reproductive health and rights through effective, evidence-based approaches to prevention and treatment of critical reproductive and sexual health concerns, and through increased funding for critical international programs and institutions.