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The FDA is set to approve the "female Viagra." Critics say it's a mistake.

The FDA might approve "female Viagra." But critics aren't convinced it'll actually help women.
The FDA might approve "female Viagra." But critics aren't convinced it'll actually help women.
PhotoSkech /Shutterstock
  1. Today, the Food and Drug Administration is expected to decide on whether it will approve a new drug designed to boost women's sex drives.
  2. Before this, flibanserin — a pill dubbed the "female Viagra" — had been on a rocky road to the market, rejected by the FDA twice since 2010 out of concerns that its harms outweigh its benefits.
  3. The pill's luck changed in June, when an FDA advisory panel urged the regulator to back the drug. The 18-6 vote was considered a "major victory" for the drug, since the FDA more often than not adopts the advice of the expert group and the same panel had voted unanimously against flibanserin in the past.
  4. Critics have raised questions about the efficacy of flibanserin. They've also accused the pharmaceutical industry of inventing the medical condition — hypoactive sexual desire disorder — that the drug would supposedly treat.

American women will soon have access to the "female Viagra"

female viagra

(El Nariz/Shutterstock)

Flibanserin (pronounced fluh-BAN-ser-in) is a daily pill made by Sprout Pharmaceuticals designed to treat low libido in premenopausal women. Today, the FDA is expected to make its decision on whether to approve the drug for market.

The news comes after a June advisory panel voted 18 to 6 to recommend that the FDA approve the drug — on the condition that Sprout can figure out how to minimize the safety risks to patients. That might entail requiring medical professionals to take a training course before being allowed to prescribe the drug or making women who want the pink pills sign an agreement saying they won't use hormonal contraceptives or alcohol while on flibanserin (since these two behaviors increased the risk of side effects).

While Viagra improves men's sexual performance by increasing blood flow, the pink pill works on women's brains, raising dopamine levels. About one in five women who took the drug have experienced side effects: most commonly, low blood pressure, dizziness, and fainting, increasing the risk of injuries such as concussions. As the New York Times reports, the results of clinical trials for flibanserin have been lackluster:

Three clinical trials testing flibanserin were consistent in their results. The women who took part were having an average of two to three of what they defined as "sexually satisfying events" per month when the studies began. Once they started taking the drug, the number of such events increased, but by no more than one event per month more than for women in the trial who got a placebo.

At the June advisory committee meeting, the FDA gave a scientific presentation against the drug, arguing that it only resulted in eight more sexually satisfying events per year (when compared with a placebo) and that side effects were common.

But the room was also filled with emotional testimony by women who feel they would greatly benefit from the medication. Sprout claims nearly one-tenth of premenopausal women suffer hypoactive sexual desire disorder.

Critics say "pink Viagra" is a Big Pharma marketing sham

Not everyone's convinced that the drug is necessary, however. Some critics question whether low sex drive is even a real medical condition that can be treated by a pill — or just an invention of Big Pharma. The condition has been discussed in the scientific literature as "a textbook case of disease mongering by the pharmaceutical industry."

Although the evidence hasn't improved since the FDA's last rejection of flibanserin in 2013, the marketing push around the drug has gained traction: Sprout put together the "Even the Score" campaign accusing the FDA of being sexist for not getting the pink pill on the market to help women.

As Paul Thacker described in Slate, the medical experts he spoke to agreed flibanserin is no "cure-all" and that the FDA has been evidence-based in its treatment of the pill. "It is hard to see what is sexist about the national drug regulatory agency refusing to approve a drug that was ineffective and like all active pharmaceutical products, has the potential for harm," one doctor told Thacker.

Dr. Adriane J. Fugh-Berman — the director of the PharmedOut project at Georgetown University who has studied the marketing campaign around flibanserin — calls the drug "a mediocre aphrodisiac with scary side effects."

"Marketing won over science today," she told Vox after the June committee meeting.

"The FDA presented a very good scientific case against the drug," Fugh-Berman said. "But the panel was convinced by the many women who had been brought there by Sprout to talk about the tragedy of their low libido, and how it was threatening their marriages. Several of them cried."