After an intense lobbying campaign, a federal
advisory panel recommended approval of what would become the first drug to
treat a lack of sexual desire in women.
The move was immediately hailed by some women’s
organizations as a step toward sexual equality by, in effect, giving women
their counterpart to Viagra, the widely prescribed drug for male erectile
dysfunction.
By a vote of 18-6, the advisory committee to the
Food and Drug Administration favored approval of the drug, flibanserin, for
women whose lack of sexual desire was not attributable to other causes such as
disease or relationship troubles, providing that certain steps were taken to
limit the risks of the drug. Doctors might be required, for instance, to inform
patients of potential side effects — like low blood pressure, fainting, nausea
and dizziness — and physicians might have to become certified to prescribe the
drug.
The controversial campaign by some women’s groups
to win federal approval was waged under the banner Even the Score, which
accused the F.D.A. of gender bias because it had approved Viagra and other
drugs to help men have sex while leaving women without options.
The participants in the campaign had been brought
together by a consultant to Sprout Pharmaceuticals, the developer of
flibanserin.
That campaign, which packed the advisory
committee meeting room with the drug’s supporters, in addition to some new data
from clinical trials, apparently helped tip the balance for flibanserin, which
has been rejected twice by the F.D.A. The first time, in 2010, came after a
similar advisory committee had voted unanimously against approval.
Now the drug could be approved by Aug. 18, the
F.D.A.’s deadline for making a decision.
The agency usually follows the advice of its
advisory committees. But Thursday’s vote was closer than the numbers indicate,
making it less clear how the F.D.A. will respond. Several committee members
said they voted “yes” with great misgivings because of the drug’s modest
benefit and possible side effects.
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