title: Missed Opportunities in the Patient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction Held at the FDA, October 2014.
abstract: There were numerous missed opportunities at the October 2014 U.S. Food and Drug Administration (FDA) meeting on female sexual dysfunction (FSD). They included opportunities to hear from a diverse range of patients and to engage in evidence-based discussions of unmet medical needs, diagnostic instruments, trial end points, and inclusion criteria for clinical trials. Contributions of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) nomenclature, based on extensive research, were dismissed in favor of language favoring a seemingly clear but scientifically unsupportable distinction between women's sexual desire and arousal. Numerous participants, including patients recruited by their physicians, acknowledged travel expenses paid for by interested pharmaceutical companies. Conflicts of interest were manifold. The meeting did not advance the FDA's understanding of women's sexual distress and represents a setback for our field.
authors.affiliation: a Department of Psychiatry , NYU School of Medicine.
authors.forename: Leonore
authors.initials: L
authors.lastname: Tiefer
authors.forename: Ellen
authors.initials: E
authors.lastname: Laan
authors.forename: Rosemary
authors.initials: R
authors.lastname: Basson
mesh_terms: D000328:Adult; D016265:Conflict of Interest; D055808:Drug Discovery / Q000592:standards*; D004493:Education; D005260:Female; D006801:Humans; D007989:Libido; D020018:Sexual Dysfunctions, Psychological / Q000175:diagnosis* / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration