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.

Notes

¹Transcripts, recordings, agendas, participant lists, and more can be found at the FDA website: http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm.

²See https://www.facebook.com/pages/Even-TheScore/1461807247387799?sk=photos_stream.

³See http://eventhescore.org.

⁴All slides from the three presentations as well as all FDA questions and the answers from the panel are available on the FDA website: http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm.