Even though I’m a medical doctor, I’m not accustomed to watching the Food and Drug Administration’s actions as closely as I have the past few months. If you’ve followed this blog, you know that last October, I traveled to Washington DC for a public hearing and then a workshop of women’s health experts. The FDA sponsored the events to hear about women’s sexual health and to examine how they might respond.
And then in June, an advisory committee to the FDA recommended the approval of flibanserin, a medical treatment to address hypoactive sexual desire disorder (HSDD). The FDA is poised to announce its decision next week.
It’s been a long road. I first wrote about flibanserin back in 2010, when the company that had developed fibanserin shelved it, saying that it didn’t have sufficient “potential to make it to market.” There’s been controversy about the HSDD diagnosis, although it was first medically characterized in 1977 in the Journal of Sex and Marital Therapy and is listed in the International Classification of Diseases.
More important to me than those scientific listings are specific women I’ve seen in my practice. They’ve had satisfying sex lives. They love their partners. They want to want intimacy. They don’t have psychological problems, relationship issues, social hang-ups, or a medical problem—beyond HSDD. Brain scans show different activity and structure in women with HSDD, proving the biological component.
As their doctor, I want to offer them options to reclaim the life they want, which includes intimacy. It’s up to each woman to decide which of the options she’s like to try, and then to determine whether each option is working for her.
Beyond the approval of this one pharmaceutical product, the FDA’s action is, I hope, a signal for a bright future. When I was there in October, I heard that the agency “recognizes that this [female sexual dysfunction, or FSD] is a condition that can greatly impact the quality of life,” and that “the FDA is committed to supporting the development of drug therapies for FSD.”
As a physician, I’m committed to the least invasive, simplest solution for each woman. But when that simplest solution doesn’t work, I’m deeply grateful for well-tested, thoroughly researched pharmaceutical options that help women restore the fullness of their lives.