FDA to Address Female Sexual Enhancement Drugs

LOS ANGELES — The topic of female sexual dysfunction — and drugs to treat it — will be front and center at an FDA meeting this month, one in a series of 20 looking at “patient-focused drug development.”

Critics have accused the Food and Drug Administration of having a gender bias, pointing out that it has approved six male-targeted drugs to help them overcome anxiety, physiology and more to get an erection, but has yet to approve a single female equivalent. 

The meeting to be held Oct. 27-28 will include statements from patients about the impact that female sexual dysfunction has had on their lives, WebMD reports. It will also include a scientific workshop to discuss how to diagnose the disorder and measure how well medications for it work.

Advocating for pharmaceutical gender inclusivity is Even the Score, a campaign that launched in June and is backed by the drug companies of at least three potential treatments for female sexual dysfunction.

A petition to the FDA posted by Even the Score on Change.org attracted more than 16,000 signatures. The petition addresses the FDA: “We urge you to work fairly and urgently toward a solution to an unmet medical need…”

Others, including the National Women’s Health Network and the American Medical Women’s Association, believe that the dearth of pharmaceutical options for women is not a gender bias, but a reflection of how much more complicated treating female sexual dysfunction can be.  

Following, they have supported the FDA’s decisions not to approve a drug for female sexual dysfunction, arguing that women may need more than a single pill to boost their libido. Viagra and Cialis target one important aspect of sex — the erection — but do not address psychological aspects of arousal, which may be key for women’s satisfaction,

Cindy Pearson, executive director of the National Women’s Health Network, says while the FDA has not been immune to gender bias, she doesn’t believe that is what’s delaying the drugs. “If it were gender bias, we would be yelling and screaming,” Pearson said. “The problem is the drugs. Our biology is so much more complicated than men’s.”