Why it took so long to approve a Viagra equivalent for women

A drug to treat low female sexual desire should be approved with strict measures in place to ensure patients are fully aware of its risks, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday. Eighteen panelists voted in favor of approving the drug with a risk management program. Six voted against approval. None voted to approve the product without such a program. The vote came as a surprise after not one but two rejections of the drug by the FDA.  Although some organizations say that sexism played a role in the FDA’s slow approval, experts say safety was the main criterion underlying the agency’s rejections for so long.

All you can measure is safety, and so you better have a safety profile that’s pretty much like taking a sugar pill.

Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York City

Several feminist organizations have pointed out that 26 drugs are now marketed for men with sexual dysfunction, and this is the first and only that has been approved for women. They argue that the FDA has repeatedly rejected flibanserin’s drug approval application because of a sexist belief that women aren’t supposed to want or need sex. But those numbers are misleading, says one expert, because there are only a few active ingredients in the many drugs for men. Also, there isn’t really a clear way for doctors to decide whether a person’s level of desire is normal, or needs fixing, says another expert. Spurring any kind of desire with just a pill is tricky, she said.

How do you make somebody want to have sex? How do you make someone want to go to work in the morning? I don’t know how a pill does that, because there are so many aspects to desire.

Elizabeth Kavaler

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