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April 2016

US Food and Drug Administration Approval of Flibanserin: Even the Score Does Not Add Up

Author Affiliations
  • 1Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire
  • 2Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
JAMA Intern Med. 2016;176(4):439-442. doi:10.1001/jamainternmed.2016.0073

Flibanserin (Addyi), the new female libido pill, is about desire, arousal, and satisfaction. The manufacturer, Sprout Pharmaceuticals (a division of Valeant Pharmaceuticals North America LLC), clearly had desire. They purchased the rights to the drug even after its initial rejection by the US Food and Drug Administration (FDA) and persisted through 2 contentious review cycles. Sprout worked hard to arouse support for the drug, helping create and fund “Even the Score,” an advocacy campaign pushing the message that sexism—not legitimate scientific questions—motivated the drug’s rejection.1 And within 48 hours of FDA approval, flibanserin was sold to Valeant Pharmaceuticals for about $1 billion in cash.2 Very satisfying.

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