By Toni Clarke
WASHINGTON Feb 11 The U.S. Food and Drug
Administration hit back on Tuesday at critics who have charged
it with gender bias for rejecting a drug for low female libido
from Sprout Pharmaceuticals.
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
The FDA's decision followed intense lobbying by women's
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
On Jan. 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 drugs.
In a follow-up letter two days later, the groups renewed
"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 affecting women."
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 email.
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
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 quarter.