Women's groups, who have lobbied heavily for the
drug's approval, pounced after the FDA denied an appeal to approve
the product, a once-a-day treatment for hypoactive sexual desire
disorder (HSDD), accusing the agency of bias.
"When it comes to approving drugs for male sexual dysfunction, the
FDA says yes with more limited research and serious side effects,
but when it comes to women, their go-slow tactics are preventing us
from having access to a treatment option where we make the decision
in consultation with our healthcare provider," said Terry O'Neill,
president of the National Organization for Women, in a statement.
The FDA rejected the charge, saying in an email that it "engaged in
a scientific process in which we evaluated whether the drug's
benefits outweigh its risk."
The FDA declined to approve the drug, flibanserin, last year saying
its effects were "modest" and did not outweigh side effects such as
dizziness, nausea and fatigue.
On Tuesday Sprout said the agency had asked for three new studies,
two to test its interaction with other drugs, and a third to
simulate driving since nearly 10 percent of women in clinical trials
became sleepy while taking it.
Sprout, which is privately held, said it welcomed the FDA's guidance
and viewed it as "a significant step" toward the once-a-day
The FDA's decision followed intense lobbying by women's advocates.
In January, Democratic lawmakers Debbie Wasserman Schultz, Chellie
Pingree, Nita Lowey and Louise Slaughter — wrote to FDA Commissioner
Margaret Hamburg urging the agency to give "careful review" to the flibanserin data and apply "the same standards of consideration
given to the approved drugs for men in your risk/benefit
On January 28 representatives from eight women's groups, including
NOW, the Center for Health and Gender Equity, Jewish Women
International and the National Council of Women's Organizations met
with Dr. Janet Woodcock, head of the FDA's pharmaceuticals division,
and conveyed their view that the standards for approval of
flibanserin exceed those required for male erectile dysfunction
In a follow-up letter two days later, the groups renewed their
"We were pleased, Dr. Woodcock, with your recognition that 24
treatment options for men contrasted with an ongoing dilemma to just
approve one for HSDD in women may signal gender bias, conscious or
unconscious," they wrote.
"We see this not only as an important unmet women's health issue,
but an inflection point for the agency to ensure that similar
standards are applied for drug approvals in conditions uniquely
[to top of second column]
The FDA, however, said there was no such "recognition" of
potential gender bias at the agency.
"We do not believe there has been any gender bias with regard to
our review of this drug and FDA did not acknowledge gender bias at
the meeting," Andrea Fischer, an agency spokeswoman, said in the
The FDA is hardly short of women in leadership positions, starting
with the commissioner, Dr. Margaret Hamburg. Woodcock herself heads
the agency's largest division and, according to the FDA's website,
the director of the office that oversees reproductive drugs and the
deputy director of the division that reviews them are women.
And while the agency has not approved any drugs to treat low female
libido, it has approved a treatment for pain during intercourse and
vulvovaginal atrophy associated with menopause.
Still, finding treatments for low female libido has proven
elusive for drugmakers. Among those trying is Palatin Technologies
Inc, which is developing a drug, bremelanotide, that it believes
affects sexual response in a novel way. It expects to start
late-stage trials in the first half of this year.
Female sexual dysfunction has been identified by the FDA as one of
several therapeutic areas that it plans to focus on as part of its
patient-focused drug development program, which aims to gather
patients' perspectives on their condition and potential treatments.
The FDA said in its email that it is committed to getting needed
therapies to women but that "all drugs need to show positive benefit
when compared to risk."
Sprout said it expects to resubmit its own application by the third
(Reporting by Toni Clarke in Washington;
editing by Eric Walsh and Tom Brown)
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