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Editorial |

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

Steven Woloshin, MD, MS1,2; Lisa M. Schwartz, MD, MS1,2
[+] 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.
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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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The US Food and Drug Administration (FDA) Division of Bone, Reproductive, and Urologic Products Clinical Review Team Votes and Rationales

The nonclinical pharmacology/toxicology team supported approval but concluded that there “was a drug-induced increase in malignant mammary gland tumors in female mice. Although the increase was small, the increases were dose-related and statistically significant…. The clinical significance of the mammary tumors in mice is unknown.”10 They recommended including this concern in the “Warnings and Precautions” of labeling to allow physicians and women to factor this uncertainty into their decisions. Red and green boxes represent the number of individual votes.11 HSDD indicates hypoactive sexual desire disorder; REMS, risk evaluation and management strategies.

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