FDA staff debate data for new female condom
WASHINGTON (Reuters) - U.S. health regulatory staff have questioned whether there are enough data to show that Female Health Co’s latest condom for women prevents pregnancy and sexually transmitted diseases, according to documents released on Tuesday.
The Chicago-based company is seeking Food and Drug Administration approval to sell its new version, called the FC2 Female Condom, to prevent pregnancy and HIV.
The company said it did not conduct clinical trials to show how well it prevents such outcomes because FC2 uses a new material but works the same way as the original version already on the U.S. market, the FDA staff said. Instead, the company compared the new version with the older one.
Female Health Co “asserts that such studies are not necessary. This is an important review issue,” the staff wrote.
Company representatives could not be immediately reached for comment.
On Thursday, the FDA will seek advice from a panel of outside experts on whether there are enough data to show the condom is safe and effective to warrant U.S. sales.
Studies were conducted on how well the new material, a synthetic rubber called nitrile, holds up against tears and other issues, the agency said. The original condom uses polyurethane.
Both versions are comprised of a sheath with a closed ring on one end that is inserted near the cervix and an open ring on the outer end that stays outside the woman’s body.
Just 10 percent of the female condom’s 34.7 million unit sales in 2008 were in the United States, according to Female Health Co.
Most other countries have already adopted the newer version, which is manufactured similarly to male condoms. That process is less-costly than the current system and should reduce costs, the company has said.
U.S. consumers currently pay between 50 cents and $2 per male condom while the female version can cost nearly $4 each, according to major retail prices online.
Shares of Female Health Co. were up 2.5 percent, or 7 cents, at $2.92 in morning trade on the American Stock Exchange.
(Reporting by Susan Heavey, editing by Gerald E. McCormick and Derek Caney)
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