FDA Panel Recommends Approval Of New, Less Costly Female Condom

Main Category: Women's Health / Gynecology
Also Included In: Sexual Health / STDs;  Regulatory Affairs / Drug Approvals
Article Date: 16 Dec 2008 - 4:00 PST

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An FDA advisory panel on Thursday voted 15-0 to recommend approval of the new, less costly version of the female condom developed by the Female Health Company, Reuters reports. Experts told the panel that the lower price of the new condom -- called the FC2 female condom -- could attract more women to the product and allow health organizations to increase distribution in an effort to curb the spread of HIV/AIDS, Reuters reports. Approval of the less costly version also could boost U.S. sales -- which accounted for 10% of the company's 34.7 million unit sales in 2008 -- Reuters reports (Heavey, Reuters, 12/11).

Currently, most of the company's U.S. sales are to development agencies such as USAID, which will not distribute the new female condom abroad without FDA approval (Daily Women's Health Policy Report, 12/11). Distribution by USAID would improve access to the condom for women in other countries, according to Mary Ann Leeper, an adviser and former president of FHC. An older version of the female condom currently on the U.S. market was approved in 1993 to help prevent pregnancy and sexually transmitted infections but has not achieved widespread use in the U.S., mainly because of its higher price compared with male condoms, Reuters reports (Reuters, 12/11). The new nitrile-based female condom, which costs less to produce than the older polyurethane version, already is available in countries outside the U.S., FHC said (Daily Women's Health Policy Report, 12/11).

More than 12 health advocates urged the panel to recommend approval of FC2, saying that the condom is a critical factor in helping women to prevent pregnancies and STIs. Michael Thomas, a panelist from the University of Cincinnati's College of Medicine, said, "This will allow women in general to take even more control of their ability to protect themselves." American Social Health Association Vice President Deborah Arrindell said, "Female condoms are the only woman-controlled method of safer sex, and we also know what the birth control pill did for women: it allowed them an unprecedented control over their reproductive status" (Reuters, 12/11).

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