FDA: FC2 Female Condom Is Approvable
The Female Health Company (NYSE Alternext: FHC) has announced that the U.S. Food and Drug Administration's (FDA) Obstetrics and Gynecology Devices Advisory Committee has unanimously voted that the company's second-generation female condom, the FC2 Female Condom, is approvable with a single condition.
The Advisory Committee voted 15-0 that the product is approvable with the condition that the FC2 Female Condom's instructions for use continue to follow use instructions for the FC Female Condom (FC1 Female Condom) and appropriately identify the study that was performed to establish the comparable safety and effectiveness of FC2 with FC1.
The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing obstetric and gynecologic devices.
"We are very pleased with today's outcome and look forward to working with the FDA as it continues to review our application for the FC2 Female Condom," said Dr. Mary Ann Leeper, FHC's Senior Strategic Advisor. "We believe that FHC's second-generation female condom can strengthen the fight against AIDS by expanding affordable access to a woman-initiated HIV prevention method."
The company filed the FC2 Female Condom Pre-market Approval Application (PMA) with the FDA on January 7, 2008 and has been working with FDA as it reviewed the application.
The company's first-generation FC1 Female Condom received FDA approval for distribution in the United States in 1993. The FC1 Female Condom is also included in the World Health Organization's (WHO) essential products list for distribution by United Nations (UN) agencies. Since its approval, 165 million FC1 Female Condoms have been distributed in 142 countries.
The FC2 Female Condom data has been reviewed by other public agencies, including the European Union, India, Brazil and the World Health Organization (WHO). In 2006, the WHO agreed that the FC2 Female Condom does perform in the same manner as the FC1 Female Condom and recommended that the FC2 Female Condom can be purchased by UN agencies. Since then, over 22 million FC2 female condoms have been distributed in 77 countries.
Performance of FC2 Female Condom in Clinical Trial
FHC presented data from a randomized, double-blind, crossover, comparative trial with the FC1 Female Condom. The FC1 Female Condom is currently distributed in over 100 countries, including the U.S. The FC2 Female Condom, which looks very similar to the FC1 Female Condom, was developed to expand access to women at risk of HIV and STIs by lowering the cost of the product through the introduction of a more efficient manufacturing process. The clinical trial was conducted in 2004 by the Reproductive Health and HIV Research Unit of the University of Witwatersrand in South Africa. Over 200 women participated in the study. The results of the study showed that the FC2 Female Condom is safe and that the risk of failure during use was equivalent to FC1. Results from the study were originally published in the journal Contraception. (See Contraception 73 (2006) 386- 393.)
Unintended Pregnancy and HIV/STI Transmission in the U.S.
Unintended pregnancy and the transmission of HIV and other STIs remain significant public health challenges in the U.S. According to the Centers for Disease Control and Prevention (CDC), approximately one-half of pregnancies in the U.S. were unintended in 2001, and contraception methods provided by federally funded family planning programs (male condoms, female condoms, the Pill, and IUDs) prevent an estimated 1.3 million unintended pregnancies each year.
Over the past two decades, the proportion of women among all people living with HIV/AIDS (PLHIV) in the U.S. has more than tripled -- from 8 percent of PLHIV in 1985 to 26 percent in 2007. HIV infection has emerged as the leading cause of death for African American women aged 25-34, high-risk heterosexual contact is responsible for 80 percent of new HIV infections among American women, and one in four young adults aged 15-20 years contracts a sexually transmitted infection each year.
In this context, expanded access to the female condom -- the only safe, effective, and available woman-initiated prevention method currently available -- can provide women and men with more options to practice safer sex and prevent unintended pregnancy.