‘Female Viagra’ finds difficult path at FDA

WASHINGTON — The Food and Drug Administration has approved 24 drugs for the treatment of male sexual dysfunction. For women, that number is zero.

The disparity reflects drugmakers’ difficulties in unlocking the secret to revving up women’s sex drives. But it also has become a rallying point for women’s advocates and even some members of Congress, who suggest that federal regulators seem more eager to approve sex-enhancing drugs for men than for women.

It isn’t every day that political leaders and groups such as the National Organization for Women get involved in the drug-approval process at the FDA, particularly for “lifestyle” drugs. But the unsuccessful quest for a “female Viagra” is sparking complicated questions about a woman’s right to a pill that may improve her sex life — and about how much of a libido lift is enough to be judged effective by the FDA.

A drug called flibanserin, touted by some as the “little pink pill,” the counterpoint to Viagra’s little blue pill, was developed 12 years ago. Last month, women’s groups were disappointed when the FDA asked for further safety tests on the medication.

Some critics believe the agency — consciously or not — may be succumbing to society’s squeamishness about women’s sexual desires compared with those of men.

“It looks to me like there are more hurdles being put in front of this drug than there have been on drugs addressing male dysfunction,” said Terry O’Neill, president of NOW. “Obviously, everyone only wants drugs to get on the market if they are proven safe and effective. But we don’t want attitudes to get in the way of a good drug.”

The FDA, which is led by a woman and has a woman at the helm of its Center for Drug Evaluation and Research, has denied the accusation. It stresses that it takes female sexual dysfunction seriously and is committed to working with companies trying to develop a marketable drug to treat it.

“We do not believe there has been any gender bias with regard to our review of this drug,” the agency said in a statement. “We engaged in a scientific process in which we evaluated whether the drug’s benefits outweigh its risk.”

Still, the agency’s reluctance to approve flibanserin, even as it signs off on new medications for men who struggle with intimacy, has gotten the attention of Congress. Last month, Rep. Debbie Wasserman Schultz, D-Fla., and three other congresswomen sent a letter to the FDA, urging “careful review employing the same standards of consideration given to approved drugs for men.” A 2008 study suggested that 12 percent of women may suffer from female sexual problems. Drugmakers have been working for years to address hypoactive sexual desire disorder, the most commonly reported type of female sexual dysfunction.

HSDD is defined as an absence of sexual fantasies and desire for sexual activity, which does not have an obvious cause, such as depression or libido-suppressing drugs, and which causes distress to the sufferer.

People diagnosed with the disorder often say they love and crave physical intimacy with their partners but are turned off by the idea of having sex with them.

“I have patients who call me who meet true criteria for HSDD, [asking] ‘Are we any closer? Is the drug out yet?’ ” said Leah Millheiser, director of the Female Sexual Medicine program at Stanford University. “There is a need for it.”