Accepted Paper:

FDA Approval of Flibanserin for Female Hypoactive Sexual Desire Disorder: A Rhetorical Study  

Author:

Judith Segal (University of British Columbia)

Paper short abstract:

The presenter attended FDA meetings on Female Sexual Dysfunction, ahead of an application for approval of flibanserin as a treatment. The paper analyzes the rhetoric leading to approval, and asks why arguments persuasive to the FDA have been unpersuasive to women who might be candidates for the drug.

Paper long abstract:

Flibanserin (Addyi) is a drug to treat Female Hypoactive Sexual Desire Disorder. The drug was presented for approval, for the third time, to the FDA in February 2015. In June 2015, an expert panel recommended the FDA approve the drug, and in August, the FDA did approve it. The story of flibanserin's approval goes back to the summer of 2014, and the launch of the largely pharma-funded campaign, Even the Score—and to October 2014, when the FDA held patient-focused meetings on the "unmet need" for an HSDD drug. I attended those meetings as a rhetorical observer, and noted, for example, that the language used there already assumed disease in the women who were recruited to report on their experience of low desire for their long-term male partners. By the language of the FDA staff who interviewed the patient panelists (mostly funded for their appearance that day by Sprout Pharmaceuticals, then owner of flibanserin), these women were there to talk about their "symptoms." The flibanserin case presents additional matters of rhetorical interest—not least, the appropriation by Even the Score of a feminist language to promote an arguably anti-feminist agenda. Addyi is now on sale in the U.S. and its market numbers have been low: only 227 prescriptions were written in its first four weeks of sale. A rhetorician's further question is then, how is it that arguments so persuasive to the FDA have turned out to be unpersuasive to women who might be candidates for the drug?

Panel T017
STS for pharmaceuticals and public health policy