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FDA Accused Of ‘Persistent Gender Bias’ For Failing To Approve A Female Version Of Viagra

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"FDA Accused Of ‘Persistent Gender Bias’ For Failing To Approve A Female Version Of Viagra"

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A blackboard in Sprout Pharmaceuticals'  Raleigh, N.C., headquarters makes an allusion to the male erectile dysfunction drug Viagra

A blackboard in Sprout Pharmaceuticals’ Raleigh, N.C., headquarters makes an allusion to the male erectile dysfunction drug Viagra

CREDIT: AP Photo/Allen G. Breed

The federal government has approved 26 different drugs to treat male sexual dysfunction. So why aren’t there any similar treatments available for women?

That’s the subject of a new campaign, “Even the Score,” that’s seeking to pressure the Food and Drug Administration (FDA) to focus on approving its first-ever drug to address low sex drive in women. A coalition of 12 different reproductive health and feminist groups are spearheading the effort, encouraging additional supporters to get involved by signing a petition to pressure the agency to dedicate more research to this area.

“Viagra, a household name, was approved in 1998. Sixteen years later, women are still waiting for an FDA-approved solution of their own and they stand ready to support decision-makers and regulators who prioritize woman’s health issues such as this one,” the group’s petition reads — noting that 43 percent of women suffer from sexual dysfunction, compared to 31 percent of men.

Although there have been multiple attempts to develop a drug treatment to enhance female libido, it’s been difficult to get anything past the FDA. The latest drug company to make a foray into this area is Sprout Pharmaceuticals, which developed a medication called flibanserin — a so-called “little pink pill” intended to provide a female counterbalance to Viagra’s “little blue pill.” But the government rejected Sprout’s application to approve the drug in 2010 and 2013, and sent it back for more testing this past February.

That sparked outrage among some medical professionals, who pointed out that the FDA’s reluctance to approve a drug for women suggests an implicit discomfort with women taking control over their sexuality. “The FDA is saying we need more driving trials because flibanserin makes women sleepy. But it’s a drug you take at bedtime,” Sheryl Kingsberg, the chief of behavioral medicine at University Hospitals Case Medical Center in Cleveland, told the American Prospect at the time.

After Sprout started fighting back against the FDA, feminist groups began to take notice of the issue. Even some members of Congress got involved — at the beginning of this year, four Democratic lawmakers penned a letter to the FDA urging the agency to use “careful review employing the same standards of consideration given to the approved drugs for men in your risk/benefit analysis.” Now, it’s come full circle. The Hill reports that Sprout is backing the new “Even the Score” campaign.

The FDA, which is led by a woman, has refuted accusations of gender bias throughout the controversy over “female Viagra.” The agency says it takes female sexual dysfunction seriously, but wants to continue working with companies to develop a drug whose benefits outweigh the potential risks.

That’s not enough for the coalition that’s signed onto the Even the Score campaign. “Despite the fact that the FDA itself chose female sexual dysfunction as one of its 20 priority areas of unmet need, women still wait for a single safe and effective FDA approved treatment for a common sexual issue that affects one in ten of them,” the groups say in their petition. “It’s time to even the score when it comes to the treatment of women’s sexual dysfunction.”

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