Adriane Fugh-Berman and Alessandra Hirsch consider the sexist roots and implications of flibanserin.
On August 18th, 2015, the U.S. Food and Drug Administration (FDA) approved Sprout Pharmaceuticals’ flibanserin (brand name Addyi), commonly called “female Viagra.” Flibanserin had previously failed to achieve FDA approval for “Hypoactive Sexual Desire Disorder” on two separate occasions. The third time was the charm. Less than 48 hours after approval, Valeant Pharmaceuticals International, Canada’s largest company by market value, acquired Sprout for one billion dollars.
This may be the first drug approved through a public relations campaign. The FDA had rejected flibanserin in 2010 and 2013, because the purported benefits of this libido-boosting drug did not outweigh the substantial risks. At an FDA Advisory Committee meeting in June 2015, no new data on benefits were presented, but new data on risks raised serious concerns about sudden prolonged unconsciousness and serious interactions with drugs and alcohol. Given these new data, what convinced a government regulatory body to approve this drug?
The answer is: A brilliant, misleading public relations campaign by Sprout Pharmaceuticals and its public relations firm, Blue Engine Message and Media. “Even the Score” accused the FDA of sexism by claiming that there are 26 FDA-approved sexual dysfunction drugs for men and zero for women. In fact, the FDA has approved eight drugs for sexual dysfunction in men and three for women – and (until now) had never approved a single libido-boosting drug for either men or women.
Sprout’s entire board of directors is male except for Cindy Whitehead, who replaced her husband as CEO several months ago (perhaps because the company realized it had a credibility problem crying sexism with only men in charge).
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.