FDA Officials To Review New Female Condom
An FDA advisory panel this week is scheduled to review a new and possibly less expensive version of the female condom for its efficacy in preventing pregnancies, HIV and other sexually transmitted infections, Reuters India reports. The Female Health Company is seeking FDA approval for its new product, called the FC2 female condom, which is manufactured with a synthetic rubber called nitrile. FHC's older version of the female condom, which already is on the U.S. market, uses polyurethane. FDA on Thursday will receive advice from a panel of outside experts about whether existing data are sufficient to prove that FC2 is safe and effective for approval in the U.S.
Some FDA officials are questioning whether FHC should have performed clinical trials to determine how well FC2 prevents pregnancies and STIs. According to Reuters India, FHC said it did not conduct clinical trials on FC2 because although the new condom uses a material different from FHC's original version, the two products function in the same way. FHC "asserts that such studies are not necessary," the FDA officials wrote in documents released on Tuesday ahead of the review, adding, "This is an important review issue." Mary Ann Leeper, an adviser and former president of FHC, said the two versions of the female condom are designed "exactly the same" and are used in the same manner, adding that the company does not "believe there is any more information required." According to Leeper, conducting another trial would take five more years and cost millions of dollars, and the "whole idea is to increase access." Although FHC has not conducted clinical trials on the new female condom, it has examined the durability of nitrile against tears and other issues, the company said.
According to FHC, FDA approval of FC2 could boost female condom sales in the U.S., which account for 10% of the company's 34.7 million unit sales in 2008. In addition, most of the company's U.S. sales are to aid agencies such as USAID, which will not distribute the new female condom abroad without FDA approval. According to Leeper, FHC has encountered difficulty marketing female condoms but hopes to partner with another company involved in promoting HIV awareness. Female condoms can cost between $2.80 and $4 each in the U.S., compared with between 50 cents and $2 each for male condoms, Reuters reports. The new nitrile-based female condom, which costs less to produce than the polyurethane version, already is available in countries outside the U.S., FHC said (Heavey, Reuters India, 12/10).