'Women's Viagra' FDA Approval Looming? Long-Term Safety Challenged

A petition from feminist groups is pushing for the approval of a 'women's Viagra' drug after accusing Food and Drug Administration (FDA) of gender bias by arguing that men have more libido-enhancing drugs available in the market than women. 

Flibanserin, the pink libido-enhancing drug made by Sprout Pharmaceuticals for women who lack the drive for sexual intercourse, was rejected twice by the FDA due its side effects including dizziness, nausea, and fatigue, The Associated Press has learned.

The application for the pink pill's approval was resubmitted on Tuesday after adding new information requested by the FDA—the results of the effectiveness of the drug on women compared to women taking a placebo. It will now be re-evaluated because scores of supporters in the form of feminist and women's advocate groups are pushing for its availability in the market.

The group accuses the agency of gender bias since there are currently 26 approved libido-enhancing drugs for men but none for women.

"There are 26 FDA approved drugs to treat various sexual dysfunctions for men (41 if you count generics!), but still not a single one for women's most common sexual complaint," said a petition from a group called Even the Score. 

"Sex is a basic human right¹.  If individuals have a medical condition that affects their sexual function, men or women, we believe they deserve access to medical treatment options and the opportunity to make a choice with their healthcare provider on whether or not that treatment is right for them."

According to Medical Daily, the petition has been signed 40,000 times by its supporters and the FDA might approve the libido-enhancing drug on June 4.

Meanwhile, the FDA counters the group's accusation saying that each drug they review goes through a scientific process and that it's quite unfortunate that the Flibanserin "drug's benefits outweigh its risk."

"We do not believe there has been any gender bias with regard to our review of this drug and FDA did not acknowledge gender bias at the meeting," Andre Fischer, an FDA spokeswoman, said in an email to Reuters. The agency is reportedly committed to approving safe and proven therapies for women. Additionally, the agency also notes that "all drugs need to show positive benefit when compared to risk."

The Even the Score campaign is backed by the National Council of Women's Organizations, Jewish Women International, the Black Women's Health Imperative and the Association of Reproductive Health Professionals, according to the New York Times.