PATH Seeks To Gain WHO, FDA Approval Of Redesigned Female Condom, New York Times Reports

Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology
Article Date: 14 Nov 2007 - 12:00 PDT

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The New York Times on Tuesday examined the global health group PATH's efforts to gain approval of its redesigned female condom. According to the Times, the female condom has never been widely used in the U.S. and never "caught on" in developing countries, where "public health workers hoped it would ... empower women and stop the AIDS epidemic in its tracks" when it was introduced in the late 1990s. About 12 million female condoms are delivered annually in developing countries, compared with about six billion male condoms, according to the Times.

PATH hopes its redesigned female condom, which is made of soft, thin polyurethane, will "succeed where its predecessor failed." The redesigned female condom is easier to insert than the older version, and it has dots of adhesive foam that adhere to the vaginal wall and expand during sex. According to PATH, 90% of couples in Mexico, Seattle, South Africa and Thailand who tested prototypes of the new female condom were satisfied with the new version's comfort and ease of use. In addition, 98% of the couples said sex with the new version was "O.K. to very satisfactory."

PATH is now seeking FDA approval for the female condom so it can be sold in the U.S., which would make it easier to license in developing countries and achieve an endorsement from the World Health Organization. The condom must go through clinical trials, which are expected to cost $3 million to $6 million, before it can be approved, the Times reports.

Michael Free, head of technology at PATH, said the clinical trials will be a "huge impediment ... because no one's willing to put up that sort of money." USAID, the Bill & Melinda Gates Foundation, the Lemelson Foundation and other groups contributed to the development of the new condom but are unwilling to cover the cost of trials, the Times reports.

Background
Peter Piot, executive director of UNAIDS, said that the use of female condoms "has remained frustratingly and tragically low."

Lois Chingandu -- director of SAfaids, an HIV/AIDS organization in Zimbabwe -- said women generally do not want their husbands to know they use female condoms because condom use often is considered a sign of infidelity and could lead to violence. In addition, a lack of marketing and training also contributed to the female condom's failure, according to Mitchell Warren, who promoted the female condom when it was first introduced (McNeil, New York Times, 11/13).

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