Flibanserin Approval: Facts or Feelings?

On August 18, 2015, the U.S. Food and Drug Administration (FDA) approved a first in class multifunctional serotonin agonist and antagonist medication, flibanserin, for the treatment of generalized acquired hypoactive sexual desire disorder (HSDD) in premenopausal women. This approval was surrounded by political posturing that has resulted in naysayers attacking the science based on their feelings rather than the facts. Although the FDA was criticized for gender bias—after all, they had fasttracked sildenafil for men with erectile dysfunction within 6 months with fewer than 2,000 subjects, whereas flibanserin for women with HSDD was repeatedly required to perform additional clinical trials and filed with approximately 11,000 subjects—whether there was actual gender bias in the FDA is no longer relevant. What is relevant is that science requires that the facts speak for themselves.