The Food and Drug Administration (FDA) angered women everywhere when they rejected Sprout Pharmaceuticals' drug flibanserin last October, meant to treat low sexual desire in women. Representatives from eight different women's groups, and even several female members of Congress protested the decision. They asked in a letter that FDA Commissioner Margaret Hamburg apply "the same standards of consideration given to the approved drugs for men in your risk/benefit evaluation."
"We've now got 24 drugs for men for either testosterone replacement or erectile dysfunction," Cindy Whitehead, Sprout's chief operating officer, told the Associated Press. "Yet there are zero drugs for the most common form of sexual dysfunction in women."
More than 50 million women experience some type of sexual dysfunction, officially known as Hypoactive Sexual Desire Disorder (HSDD), and in fact it is more common in women (43 percent) than men (31 percent).
These women's groups have deemed the FDA's decision as sexist. Almost 60 percent believe that society places more emphasis on men's sexual satisfaction than on women's, according to a recent public opinion poll by the International Society for the Study of Women's Sexual Health (ISSWSH).
Flibanserin is designed to increase libido in women by acting on brain chemicals linked to mood and appetite. But women taking the drug reported only 1.7 more satisfying sexual experiences per month than women taking placebo. The FDA denied the drug's approval based because it was "moderately" effective, and stands by its decision.
"It is hard to see what is sexist about the national drug regulatory agency refusing to approve a drug that was ineffective," said Barbara Mintzes, an assistant professor at the University of British Columbia.
Sprout is launching an appeal, but chances for approval appear slim: Of the 17 appeals the FDA considered last year, 14 were denied, according to government figures. This is the second time since 2010 that the FDA has rejected flibanserin, and will make a decision on Sprout's appeal in the first quarter of next year.
