December 10, 2008

FDA Reviews Less-Costly Female Condom

The U.S. Food and Drug Administration (FDA) will begin reviewing a less-costly version of the female condom this week.

An advisory panel of outside experts will consider whether the FC2C Female Condom, made by Chicago-based Female Health Co., adequately protects users against pregnancy, HIV and other sexually transmitted diseases. 

The female condom gives women their own option for protection, allowing them to insert a condom prior to intercourse.  It also has other advantages over the male condom, the company said, including better protection by covering part of a woman's outer genitals.

The FDA will seek a recommendation from the panel on Thursday before making a final decision.

The new condom, which consists of a synthetic rubber, is made using a similar but less labor-intensive process than the one used to make male condoms, which come in a variety of brands and typically cost between 50 cents and $2 each.

Traditional female condoms cost between $2.80 and $4 a piece.  Female Health is seeking FDA approval to market the new version.

"The whole idea is to increase access," Mary Ann Leeper, an adviser and former president of Female Health, told Reuters.

The FDA has questioned whether the company should have conducted specific trials to prove the FC2 prevents pregnancy and sexually transmitted diseases.  In documents released on Tuesday, FDA regulatory staff said the company did not conduct such tests because the new condom is comparable to the version already on the market, although it consists of a new material.   

Female Health "asserts that such studies are not necessary. This is an important review issue," the FDA staff wrote.

The new condoms are made from a synthetic rubber called nitrile, whereas the original version uses polyurethane.  Both versions consist of a sheath with a closed ring on one end and an open ring on the outer end that remains outside the woman's body.

Conducting an additional trial would have taken five years and cost millions of dollars, according to Leeper.

"The design is exactly the same, how you use it is exactly the same ... we just don't believe there is any more information required," she said.

Most countries outside the U.S. have adopted the newer version of the condom, Female Health said.

FDA approval could help drive U.S. sales, which currently comprise just 10 percent of the female condom's 34.7 million unit sales this year.

"We haven't been able to market the product," said Leeper, adding that the company seeks to collaborate with others, such as a male condom manufacturer or a pharmaceutical company, invested in human immunodeficiency virus (HIV) awareness.

Most of Female Health's U.S.-based sales are to aid agencies, such as the U.S. Agency for International Development, which requires FDA approval of the FC2 before it can distribute the product abroad, Leeper said.

The majority of the condom's use is in other countries, particularly in Africa, where public health agencies provide the condom to prevent HIV transmission.

Shares of Female Health Co. closed at $2.96, up nearly 1.6 percent, or 5 cents, on the American Stock Exchange.


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