Female Viagra and the FDA: The agency’s rejection of flibanserin has nothing to do with sexism.

The FDA’s Rejection of Female Viagra Wasn’t Sexist. It Was Good Science.

The FDA’s Rejection of Female Viagra Wasn’t Sexist. It Was Good Science.

What women really think about news, politics, and culture.
April 6 2014 10:15 PM

How to Handle FDA Rejection

Women’s groups are calling the FDA sexist for not approving female Viagra. They are so wrong.

female pill.
Is the absence of an effective "Viagra" for women a result of sexism?

Photo by Khuntapol/Thinkstock

When the FDA denied Sprout Pharmaceutical’s bid last October to begin marketing flibanserin, a drug aimed at treating low sexual desire in women, women’s groups responded in anger. In January, representatives from eight different women’s groups, including the National Organization of Women, met with Janet Woodcock, the FDA’s head of pharmaceuticals, to protest the decision. Congress also got in on the act, with Reps. Debbie Wasserman Schultz, Chellie Pingree, Nita Lowey, and Louise Slaughter sending a letter to FDA Commissioner Margaret Hamburg to implore that, when evaluating drugs for female dysfunction (in medical terms Hypoactive Sexual Desire Disorder, or HSDD), Dr. Hamburg apply "the same standards of consideration given to the approved drugs for men in your risk/benefit evaluation."

“We’ve now got 24 drugs for men for either testosterone replacement or erectile dysfunction,” Cindy Whitehead, Sprout’s chief operating officer told the Associated Press. “Yet there are zero drugs for the most common form of sexual dysfunction in women.” Anita H. Clayton, the interim chair of the department of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine, was more explicit, writing in a blistering column for the Huffington Post: “For the millions of women with HSDD, the FDA must overcome the problem of institutionalized sexism—unconscious and perhaps unintended, but damaging nonetheless.”

The chorus was loud and clear: The FDA is sexist. The federal agency charged with approving drugs to protect and improve our health is now standing in the way of a woman’s right to have a satisfying sex life. This framing played out in numerous stories, with similar charges appearing in the American Prospect (“the FDA’s kinda sexist”), and the Washington Post (“Some critics say the agency—consciously or not—may be succumbing to society’s squeam­ishness about women’s sexual desires compared with those of men”). Not to be outdone with mere institutional sexism, a writer for the Wire mused whether “blatant, medieval sexism is also at play.”


So where did the idea that sexism it to blame for the FDA’s rejection of flibanserin come from? It appears from Sprout itself.

Pharmaceutical companies have long been trying, and failing, to develop a pill to treat female sexual dysfunction. According to a study cited on Sprout’s website, “43% of women experienced some type of sexual dysfunction compared to 31% of men.” And the most common complaint from these women is low sexual desire. But, according to several medical experts I contacted for this story, the very idea that women can be cured from low sexual desire with a pill was created years ago by the drug industry. Flibanserin, they argue, is far from a cure-all.

“It is hard to see what is sexist about the national drug regulatory agency refusing to approve a drug that was ineffective and like all active pharmaceutical products, has the potential for harm,” says Barbara Mintzes an assistant professor at the University of British Columbia and co-author of the 2010 book Sex, Lies, and Pharmaceuticals: How Drug Companies Plan to Profit from Female Sexual Dysfunction.

Many of the doctors accusing the FDA of sexism have received some sort of monetary compensation from Sprout. Dr. Sheryl Kingsberg, chief of behavioral medicine at University Hospitals Case Medical Center and a vocal critic of the FDA’s rejection of flibanserin, told the American Prospect, “There’s some underlying institutional sexism at play.” She added: “The FDA is saying we need more driving trials because flibanserin makes women sleepy. But it’s a drug you take at bedtime.” In another story about the FDA’s rejection of flibanserin, Kingsberg blamed a double standard in society's "willingness to allow women to take any risk for improving their sexual health." Neither story disclosed that Kingsberg receives consulting fees from Sprout. Anita Clayton, who wrote that passionate HuffPo plea, is also a consultant for Sprout, which was not disclosed in her piece. And the International Society for the Study of Women’s Sexual Health (ISSWSH), which conducted a poll that found “[n]early two-thirds of women polled believe it's inappropriate that the score is 24-0 when it comes to federal approval of treatments for desire, arousal or orgasm dysfunction in men vs. women,” is also financially connected to Sprout. Not disclosed in the press release for that poll is that the group’s leader, Irwin Goldstein, director of sexual medicine at Alvarado Hospital, has also received funding from Sprout. (When I reached out to Sprout, the company confirmed that Goldstein, Kingsberg, and Clayton have been compensated by Sprout for their research and consulting services, and added that they believe in “the need for healthcare professionals to be open about their financial relationships with the healthcare industry.”)

Sprout says that while many groups have been vocal about the FDA’s rejection of flibanserin, Sprout executives have not made accusations of sexism at the FDA. The company has definitely been pushing the talking point, which organizations like NOW are repeating, that there are zero drugs available for women but almost two dozen for men. However, that’s a misleading claim: Viagra has several generics approved for use, but when you count actual active ingredients, there are really only a handful of available therapies for male dysfunction.

The lack of a magic pill to cure female sexual dysfunction has long been blamed on sexism, of some sort. “Any time a drug comes around as the female Viagra, that framing of sexism comes up,” says Amy Allini, deputy director of the National Women’s Health Network. “I think that Sprout has picked up on that and is trying to do something strategic. But it didn’t start with them.”

Allini’s organization sent a letter to the FDA urging the agency to not approve flibanserin because it failed to work and had serious side effects. “[W]hile the Network agrees with Sprout’s assertion that women deserve to have our problems with sex taken seriously, we do not believe that a minimally effective drug that must be taken daily, causes significant side effects and has not been evaluated for long-term safety offers women a serious solution,” the letter reads.