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FDA Approval of Flibanserin, 'Female Viagra,' Hangs in the Balance

FDA Approval of Flibanserin, 'Female Viagra,' Hangs in the Balance
A tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, North Carolina, headquarters. (AP Photo/Allen G. Breed, File)

By    |   Tuesday, 18 August 2015 03:45 PM EDT

The FDA will decide Tuesday whether to approve flibanserin, or the little pink pill known as the "female Viagra."

The drug is designed to treat women with a low libido, but questions over potential side effects remain, USA Today reported.

Sprout Pharmaceuticals, of Raleigh, North Carolina, is trying for the third time to win approval from U.S. Food and Drug Administration. Since 2010, the agency has rejected the drug on two other occasions, but flibanserin this time has the support of groups like the National Organization for Women and an advocacy group Even the Score.

An advisory panel recommended approving flibanserin 18-6 in June, but the FDA is not bound by that decision, according to Politico.

"Women have the right to make their own informed choices concerning their sexual health; that gender equality should be the standard when it comes to access to treatments for sexual dysfunction; and that the approval of safe and effective treatments for women's sexual dysfunction should be a priority for action by the FDA," wrote Susan Scanlan in a Huffington Post essay last year.

The FDA rejected the drug in the past because it felt the medical risk outweighed any benefit it could provide. Some health experts fear that political pressure is the only thing that has changed in regards to flibanserin.

"I do think FDA is feeling public pressure because of misinformation that's put out there," Susan Wood, who guided the FDA's Office of Women's Health from 2000-2005, told Politico.

Some critics have been harsher, calling flibanserin little better than a placebo in improving a woman's libido while exposing them dangerous side effects, according to an open letter to the FDA in July signed by about 200 health professionals.

"Approving flibanserin will not only unleash an unsafe drug onto the U.S. market, but will send a message to industry that pressuring the FDA through public relations campaigns can get a drug approved," one letter, whose lead author Adriane Fugh-Berman is an associate professor at Georgetown University Medical Center in Washington, read.

Dr. Keesha Ewers, the founder and chief medical officer of The Functional Sexology Institute, said in a statement earlier that month that she believes the pill simply sends the wrong message for women.

"There is no pill, no hormone, and no one-size-fits-all solution to such a complex and multi-dimensional experience as sexual desire," she said.

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TheWire
The FDA will decide Tuesday whether to approve flibanserin, or the little pink pill known as the "female Viagra."
fda, approval, flibanserin, female, viagra
394
2015-45-18
Tuesday, 18 August 2015 03:45 PM
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