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Date Title  
7/13/2015 NV Letter to FDA asking to reject flibanserin  

 On July 13, The New View sent a letter with 100+ signers to the FDA asking for flibanserin to be rejected. Here's a brief version:

The undersigned health experts, sex researchers and clinicians write to request that the FDA reject the NDA for flibanserin submitted by Sprout Pharmaceuticals for the treatment of HSDD in premenopausal women.

We believe that the 0-18-6 advisory committee vote on June 4 occurred because of a confusing scientific picture and the interference of “Even the Score,” a carefully orchestrated public relations campaign initiated by the makers of flibanserin and other companies with sexual pharmaceuticals in the pipeline. Approval would set a dangerous precedent and send the wrong message to the public that a drug for chronic use with a poor risk-benefit profile can be successfully promoted by unethical tactics.

I.

As sex reseachers and clinicians we recommend that flibanserin be rejected because clinical definitions of women’s sexual problems are changing in important ways that flibanserin studies have ignored. The classification changes between DSM-IV to DSM-5 represent a substantial and beneficial shift in our understanding of sexual desire.

The FDA Scientific Workshop on Female Sexual Interest/Arousal Disorder held October 28, 2014 was supposed to illuminate these issues, and the comprehensive list of questions posed by the FDA to the Scientific Workshop Panel should have produced a thoughtful examination. However, as discussed in a recent Journal of Sex Research commentary, “Missed Opportunities in the Patient-Focused Drug Development Public Meeting…,” the makeup of the Panel Roster and the contentious atmosphere engendered by the lobbying of the “Even the Score” campaign prevented this from happening. The discussion was largely based on opinion and anecdote and the meaning and implications of the HSDD-FSIAD shift were never explored.

 The full letter will be posted soon

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