FDA Panel Backs 'Female Viagra'

Flibanserin recommended for approval by FDA advisory panel

An advisory panel for the US Food and Drug Administration (FDA) voted to recommend approval of a drug to treat lack of sexual desire in women by an 18-6 margin last week.

The move doesn't constitute official approval by the FDA, which is expected to make a final decision on the approval of flibanserin by an Aug. 18 deadline. The vote instead serves as a recommendation, and the agency tends to follow the panel's lead, according to The Washington Post.

Outside of the advisory panel, public support for the drug — which has been compared to Viagra, which treats erectile dysfunction in men — has been generally positive and has even included backing from several women's groups.

As committee member and Rutgers University drug safety expert Dr. Tobias Gerhard put it to The New York Times, "The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point."

Those limitations may include a requirement that doctors warn patients of potential side effects like low blood pressure, fainting, nausea and dizziness. There's also a possibility that doctors might have to become certified to prescribe flibanserin.

The New York Times reports that some women's groups lobbied for the drug's approval as part of a campaign called Even the Score. Their argument was essentially that the FDA had an obligation to approve flibanserin in the interest of gender equality. According to the Times, the campaign was in part assembled by a consultant to Sprout Pharmaceuticals, the company that created flibanserin.

Even the Score was predictably pleased with the results of the vote.

"Today, we write a new chapter in the fight for equity in sexual health," said Even the Score chairwoman Susan Scanlan in a statement.

Citing the corporate influence behind efforts to have the drug approved, critics were far less enthused.

Georgetown University's Dr. Adriane Fugh-Berman argued to the Times that, "To approve this drug will set the worst kind of precedent — that companies that spend enough money can force the FDA to approve useless or dangerous drugs."

Dr. Fugh-Berman directs an organization called PharmedOut, which scrutinizes the role drug companies play in influencing the medical community.

So long as there's market demand, however, a drug like flibanserin seems destined for approval. Politics aside, there's still a fundamentally health-centered issue at the heart of the debate.

Sally Greenberg, executive director of the National Consumers League, laid out the need for treatment.

"[Low sexual desire is] very destructive to their relationships, to their families and their self-image," she told The New York Times. "We know this is a problem with their brain chemistry. Just like depression. And, just like depression, their brain chemistry can be adjusted. We can treat it. And we should treat it."