Tomorrow, the Food and Drug Administration’s Obstetrics and Gynecology Devices Panel (an advisory committee) will consider and vote on a premarket approval application for the FC2 Female Condom for HIV and pregnancy prevention.
This type of application means that the company making the condoms, the Female Health Company, believes the product is “substantially equivalent” to the female condom that is already on the market (sometimes know as the “Reality” condom, which is another FHC product). Whether the two products are equivalent is something the advisory committee will discuss, as this has bearing on whether the maker is required to do studies of clinical outcomes (STI/HIV and pregnancy prevention) in the FC2 condom or not.
According to Reuters, a representative of the company indicated that (regarding further testing and comparison to the first generation female condom): “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.” The only thing that seems to make the two products different is a material change from polyurethane to a “synthetic nitrile;” company literature explains that this change should “improve affordability.”
The panel will also discuss the data on “breakage, mis-direction, invagination, and slippage,” and what information should be included on the product label.
Pamela Merritt has further discussion of the product and the process at RH Reality Check, including links to a letter of support for approval that several organizations have put together and individuals and organizations can sign. She explains:
“The FC2 has been approved by the World Health Organization and the United Nations Population Fund for distribution by HIV/AIDS and family planning organizations. FDA approval would enable USAID to purchase larger quantities of female condoms and distribute them to non-governmental agencies providing services to the millions of women living in nations with high HIV/AIDS infection rates.”
If you are in the Gaithersburg, Md., area, the meeting is open to the public (see details).