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You are here: Home / All Posts / The folly of the FDA

The folly of the FDA

August 19, 2015 by Andrea Mrozek 2 Comments

Today, “female viagra” was approved by the FDA.

If you want to read about how and why this happened, click here.

Flibanserin, a serotonergic drug, was initially in clinical trials as an antidepressant. Despite its history of being a “thrice failed antidepressant,” Sprout persevered and used the “finding” that some women in the drug trials said they experienced a slight increase in sexual desire as the reason to repackage the drug. Flibanserin was soon in clinical trials for Hypoactive Sexual Desire Disorder (HSDD), an indication listed in the previous edition of the Diagnostic and Statistical Manual of Mental Disorders). Sprout now maintains that HSDD is comparable to the DSM-5’s “Female Sexual Interest/Arousal Disorder,” and that women deserve a drug to treat this disorder.

As part of the attempt to gain approval for its drug, Sprout  initiated an ingenious marketing campaign, “Even the Score,” claiming that there was a sexism inherent in the number of FDA-approved treatments for sexual disorders: 26 for men and “zero for women.” However, this claim was false. There are only 8 drugs that treat male sexual dysfunction, and none are FDA-approved for low libido.

However, the “Even the Score” campaign worked. Sprout was able to get women’s groups to sign on to the idea that getting this drug approved was almost akin to getting Title IX passed.

Keep reading. It’s pretty fascinating stuff about the politics of drug approval for conditions that don’t exist, with no proof they do anything over and above a placebo.

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