September 1, 2015

Evaluation of FlibanserinScience and Advocacy at the FDA

Author Affiliations
  • 1Division of General Internal Medicine and Center for Pharmaceutical Policy and Prescribing, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 2Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania
  • 3Department of Medicine and Center for Patient Care and Outcomes Research, Medical College of Wisconsin, Milwaukee
  • 4Center for Drug Safety and Effectiveness and Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 5Section of General Internal Medicine, Department of Medicine, Johns Hopkins Medicine, Baltimore, Maryland

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;314(9):869-870. doi:10.1001/jama.2015.8405

On June 4, 2015, the US Food and Drug Administration (FDA) convened a scientific advisory committee meeting to review the efficacy and safety of flibanserin, a new molecular entity for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. This was the second such meeting of the committee regarding a product that had twice been rejected by the FDA due to an unfavorable risk-benefit profile. After the day-long hearing, the advisory committee voted 18 to 6 in favor of recommending approval of the drug, provided certain risk management options were implemented. The FDA is not bound to this recommendation and has indicated that it will rule on the product’s application by the end of August. Regardless of the outcome, the FDA’s decision is certain to join other controversial regulatory decisions at the intersection of science, policy, and advocacy. In this Viewpoint, we discuss the history of flibanserin and provide insight about the regulatory process from the point of view of 3 of the advisory committee members at the FDA meeting.

First Page Preview View Large
First page PDF preview
First page PDF preview