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.
The company said it also looked at durability of the new material, a synthetic rubber called nitrile. 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.
Conducting another trial would have taken five more years and cost millions of dollars, Female Health's Leeper said.
"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.
FDA approval could help boost sales in the United States, which make up just 10 percent of the female condom's 34.7 million unit sales in 2008, according to Female Health Co.
"We haven't been able to market the product," Leeper said. But Female Health is seeking to partner with another company, perhaps a male condom manufacturer or a drugmaker invested in human immunodeficiency virus (HIV) awareness, she said.
Most of its U.S. sales are to aid agencies, including the U.S. Agency for International Development, which Leeper said needs FDA to approve FC2 before it can distribute it abroad.
The bulk of the condom's use is in other countries, particularly in Africa where public health agencies provide it to help prevent the spread of the HIV virus.
The female version gives women their own option for protection and allows them to insert a condom before intercourse. Most other countries have already adopted the newer version, the company has said.
It also offers other advantages over the male condom, according to the company, including greater protection by covering part of a woman's outer genitals.
Shares of Female Health Co. were up nearly 5 percent, or 13 cents, at $2.98 on the American Stock Exchange.
(Editing by Gerald E. McCormick, Derek Caney and Bernard Orr)
news source of www.news.yahoo.com
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.
The company said it also looked at durability of the new material, a synthetic rubber called nitrile. 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.
Conducting another trial would have taken five more years and cost millions of dollars, Female Health's Leeper said.
"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.
FDA approval could help boost sales in the United States, which make up just 10 percent of the female condom's 34.7 million unit sales in 2008, according to Female Health Co.
"We haven't been able to market the product," Leeper said. But Female Health is seeking to partner with another company, perhaps a male condom manufacturer or a drugmaker invested in human immunodeficiency virus (HIV) awareness, she said.
Most of its U.S. sales are to aid agencies, including the U.S. Agency for International Development, which Leeper said needs FDA to approve FC2 before it can distribute it abroad.
The bulk of the condom's use is in other countries, particularly in Africa where public health agencies provide it to help prevent the spread of the HIV virus.
The female version gives women their own option for protection and allows them to insert a condom before intercourse. Most other countries have already adopted the newer version, the company has said.
It also offers other advantages over the male condom, according to the company, including greater protection by covering part of a woman's outer genitals.
Shares of Female Health Co. were up nearly 5 percent, or 13 cents, at $2.98 on the American Stock Exchange.
(Editing by Gerald E. McCormick, Derek Caney and Bernard Orr)
news source of www.news.yahoo.com
