FDA
Panel To Review New Female Condom
Dec. 12, 2008. A U.S. Food and Drug Administration Agency (FDA)
advisory panel in
December, 2008, 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 made 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 in December, 2008, 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. The new nitrile-based female condom,
which costs less to produce than the
polyurethane version, already is available
in most countries outside the U.S., FHC said.
However, 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 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 50 cents
to $2 each for male condoms, Reuters reports (Heavey,
Reuters
India, 12/10/08).
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