UNITED STATES: FDA Advisers Back New Female Condom

Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.

UNITED STATES: FDA Advisers Back New Female Condom

Reuters (12.11.08) - Friday, December 12, 2008
Susan Heavey

An advisory panel to the Food and Drug Administration backed a new version of Female Health Co.'s female condom on Thursday. "This will allow women in general to take even more control of their ability to protect themselves," said Michael Thomas, a panelist from the University of Cincinnati's College of Medicine. More than two dozen advocates spoke in the product's favor prior to the 15-0 vote.

In 1993, FDA approved Female Health Co.'s original female condom. The product's domestic appeal was limited, with just 10 percent of 34.7 million unit sales taking place in the United States. Two barriers to sales became evident: price, with the female condom costing $2.80 to $4 each, compared to as little as 50 cents for male condoms; and the polyurethane material of which the condom is made.

"When I talk to my patients - the biggest concern they have is that it's noisy - 'a snap, crackle, pop,'" said Stanford University Medical Center gynecologist Paula Hillard.

The improved product, FC2, seeks to address both problems. It is constructed of synthetic rubber, and the simpler manufacturing process - similar to that of male condoms - will reduce its cost. In addition, the softer material may entice more women to try it.

FDA tends to follow the advice of its review panels. FDA approval of FC2 would also permit its distribution in other countries by the US Agency for International Development. FC2 has already been adopted in many other nations.
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