Chicago Tribune - December 16, 2008
Judith Graham, jegraham@tribune.com

If, as expected, the FDA heeds the panel's recommendation, this altered contraceptive optionùdesigned primarily for women who want to avoid sexually transmitted infectionsùcould become available in the U.S. by mid-2009. The panel approved the new version late Thursday.

Costs will be about 30 percent less than the existing version, making female condoms more affordable to individuals and public health organizations, said Mary Ann Leeper, senior strategic adviser to the Female Health Co., the Chicago firm that manufactures the product.

In developing countries, female condoms sell for about 80 cents a piece. In the U.S., prices are $1.15 to $2.75 each, depending on whether they are distributed through public health organizations or retail outlets, she said.

In part because of the high price, the product never really caught on in the U.S. Users also complained it was difficult to insert, slippery, sometimes squeaky during sex and unsightly.

The second-generation female condom will be made of a cheaper synthetic rubber product instead of polyurethane, the material currently used. The product is a long, lubricated sheath, anchored at either end by a flexible ring. Upon insertion, the smaller ring surrounding the closed end of the sheath is positioned high in the vagina while the larger ring extends outside the canal and covers the labia.

The FDA approved the original product, known as FC1 (female condom 1), in May 1993. Research shows it has a 5 percent failure rate in the U.S., compared with a 3 percent failure rate for male condoms. For the year ending Sept. 30, 35 million FC1 condoms were sold worldwideù90 percent of them in developing countries.

The hope is that the second-generation product, known as FC2 (female condom 2), will expand the market and lead to sales of up to 200 million female condoms a year, Leeper said.

One hundred seventy women's health, reproductive health and HIV/AIDS groups urged the FDA panel to endorse FC2 in a letter last week, writing, "The feminization of HIV and AIDS requires a woman-centered response and access to a range of safe, effective and affordable prevention methods for womenùincluding female condoms." Half of the 33.2 million people living with HIV/AIDS are women.

Catherine Christeller, executive director of the Chicago Women's AIDS Project, one of the organizations listed, said, "For women, this isn't just about controlling pregnancy: It's about protecting their health and potentially saving their lives."

Many men still simply refuse to use condoms, putting women at risk of contracting sexually transmitted diseases, she noted.

Other Illinois organizations that endorsed FC2 in the letter were the AIDS Foundation of Chicago, the Chicago Foundation for Women, the Chicago Recovery Alliance, the Open Door Clinic in Elgin, the South Side Help Center and the University of Illinois Project WISH.

The FDA advisory panel voted unanimously to approve FC2.

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