FDA panel set to weigh new female condom

By Susan Heavey

WASHINGTON (Reuters) - A new, potentially less expensive version of the female condom faces U.S. regulatory review this week when a Food and Drug Administration advisory panel weighs whether they adequately prevent pregnancy, HIV and other sexually transmitted diseases.

The FC2 Female Condom, made by Female Health Co, is made with a synthetic rubber using a process similar to male condoms that the company says is less labor intensive and should reduce its current cost.

Male condoms, which come in a variety of brands and cost consumers between 50 cents and $2 a piece, are far more widely used than their female counterpart, which costs between $2.80 and $4.

Chicago-based Female Health is seeking FDA approval to market the new version. On Thursday, the agency will seek a recommendation from its panel of outside experts before later making its final decision.

"The whole idea is to increase access," said Mary Ann Leeper, an adviser and former president of the company.

But FDA regulatory staff questioned whether the company should have conducted specific trials to show how well the FC2 prevents women from contracting diseases or becoming pregnant.

Female Health said it did not conduct such studies because FC2 uses a new material but is otherwise similar to the version already on the U.S. market, the FDA staff said in documents released on Tuesday ahead of the panel meeting.

The company "asserts that such studies are not necessary. This is an important review issue," the staff wrote.