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FDA advisers back new female condom
GAITHERSBURG, Maryland |
GAITHERSBURG, Maryland (Reuters) - A potentially less-costly version of Female Health Co's condom for women won unanimous backing from a U.S. Food and Drug Administration advisory panel on Thursday.
A lower price could attract more users and allow health organizations to distribute more of the condoms to help stem the spread of the virus that causes AIDS, the panel heard.
The new version is also quieter, with panelists saying the new, softer material could win over more American women.
"When I talk to my patients ... the biggest concern they have is that it's noisy ... a 'snap, crackle, pop'," said Paula Hillard, a gynecologist at Stanford University Medical Center.
The panel of experts voted 15-0 to recommend the FDA approve the FC2 Female Condom. The agency usually follows the advice of its advisers.
"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.
Female Health's original female condom was approved in 1993 to prevent pregnancy as well as sexually transmitted diseases but has not developed widespread use. Just 10 percent of its 34.7 million unit sales in 2008 were in the United States.
Part of the issue is price. Male condoms come in a variety of brands and retail for as little as $50 cents each, while the current Female Condom runs between $2.80 and $4 a piece.
The current version requires welding sheets of polyurethane to form a sheath, then welding rings at each end. The newer one, made of synthetic rubber, uses a simpler process similar to male condoms that should cut costs, the company said.
FDA approval of the cheaper version should allow more women access to the only female condom available, the company said. "The key in the U.S. has always been cost," Mary Ann Leeper, an adviser and former president of the company, told Reuters.
FDA approval could also help women in other countries, as the U.S. Agency for International Development needs FDA approval before it can buy the cheaper version, Leeper said.
Most other countries have already adopted FC2.
More than a dozen health advocates urged panel support of FC2, saying its use was critical to help more women protect themselves. Unlike male condoms, the female product can be inserted well before sexual intercourse begins.
"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," said American Social Health Association Vice President Deborah Arrindell.
Even with approval, Leeper said it will take time for the company to relaunch it for U.S. consumers. The company is looking for a marketing partner to help distribute it more widely, she said.
The only other condom for women ever sold was the Gee Bee ring during the 1930s by another maker, before devices required FDA approval.
Ahead of the advisory panel's recommendation, shares of Female Health closed up 3.8 percent at $3.28 on the American Stock Exchange.
(Editing by Bernard Orr and Tim Dobbyn)
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