Today, a Food and Drug Administration (FDA) committee voted 18-6 in favor of approving flibanserin, a pill that's earned the nickname "Viagra for women." It's meant to treat premenopausal women suffering from hypoactive sexual desire disorder (HSDD), which is characterized as "persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity," according to an FDA briefing document. Basically, when you have HSDD, your libido goes MIA. More than that, for women dealing with this problem, a lack of sexual interest can be seriously distressing.
Although the drug won't be officially approved or rejected by the FDA until August, the decision is a landmark moment in flibanserin's layered history. The vote came on the heels of intense criticism that the FDA was being biased against women by rejecting the drug two previous times, first in 2010 under pharmaceutical company Boehringer Ingelheim, then in 2013 with Spout Pharmaceuticals, which still owns it. Read on for the controversy that's followed fliban-serin's approval process.
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Has Gender Bias Been Involved?
The struggle to get flibanserin approved has seemingly pitted some women's health advocacy groups against the FDA. One, Even the Score, has been vocal about how the medical industry treats women's sexual issues as lesser than men's. "Millions of women living with this disorder don’t have a single FDA-approved treatment option for HSDD,” says Even the Score's Change.org petition to Stephen Ostroff, acting FDA commissioner. “And that’s while men have 26 FDA-approved treatments marketed for male sexual dysfunction. You read that correctly: 26."
Groups like The National Organization for Women and CHANGE: Center for Health and Gender Equity have joined in on the fight, writing letters to Janet Woodcock, M.D., the director of Center for Drug Evaluation and Research. These calls to action all maintain a similar theme: The FDA should take this chance to potentially change women's sex lives for the better, or at the very least, seriously consider it.
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Some government officials have also voiced their support. "We firmly believe that equitable access to healthcare should be a fundamental right, regardless of whether you are a man or a woman,” says a March 26 letter from 11 Congressional representatives to then-FDA commissioner Margaret Hamburg. “But when it comes to sexual health—and, in particular, sexual dysfunction—that is not the case." The letter goes on to say that over 11,000 women have undergone clinical trials for flibanserin, allegedly the most ever for a women's drug, and that the potential side effects pale in comparison to the ones from products intended to keep men's blood pumping in all the right places. "The most common side effects observed in clinical trials for a drug to combat HSDD were fatigue, nausea, sleepiness, difficulty sleeping, dizziness, and dry mouth,” say the members of Congress. “By contrast, the 26 FDA-approved drugs for male sexual dysfunction list side effects ranging from prolonged erection, blindness, heart attack, and stroke."
The FDA has countered claims that there is sexism afoot. "The agency evaluates drugs based on science and strongly rejects claims of gender bias," says Andrea Fischer, an FDA spokeswoman. Plus, there are two classes of FDA-approved medications to treat pain during intercourse and two classes of FDA-approved medications to treat erectile dysfunction, she says. Beyond that, there's one FDA-approved treatment for Peyronie's disease, a condition that causes abnormal curvature of the penis. The FDA's bottom line: There isn't a single FDA-approved drug to treat actual sexual desire or orgasm in men (treating erectile dysfunction is technically about helping the blood pump to the penis properly, so it doesn't qualify). That includes what the FDA says are dozens of testosterone products included in the "26 FDA-approved drugs" the letter from Congress cites. "The testosterone therapies are only approved as replacement therapy in men who have low testosterone levels due to specific medical conditions,” says Fischer. “None of the testosterone therapies are FDA-approved to specifically treat male sexual dysfunction."
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What's more, the FDA says in its two prior reviews of flibanserin, there wasn't enough proof that the potential risks of the drug outweighed the benefits. In the first review cycle, the FDA rejected the drug based on nine concerns ranging from lack of statistically significant change in one of the measures of sexual desire to an incomplete 12-week trial, according to the June 4 meeting materials. The second time around, there were six major factors including a clinically significant flibanserin-alcohol interaction and fatigue that could potentially cause accidental injury. Each of the 18 members who voted to recommend flibanserin mentioned the caveat that those risks need to be reduced, and the six who were against it frequently called upon the side effects when explaining why. Still, more of them than not thought it showed enough promise to earn the recommendation.
The gender equity debate is certainly a piece of this puzzle, but parsing it out shouldn't come at the risk of forgetting who's at the middle of this conversation: real women who are distraught over their lack of sexual desire. When it comes down to it, these advocacy groups and the FDA have the same end goal of finding a safe method of treatment that can improve as many sex lives as possible—and, most important, women's sexual self-esteem. An official backing for approval while requiring more scientific exploration of side effects is a middle-of-the-road choice that will hopefully help tons of women in the near future.
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