FDA Scientific Workshop – Female Sexual Interest/Arousal Disorder

Publication Date: October 28, 2014

By: Cindy Pearson

Food and Drug Administration Scientific Workshop on Female Sexual Interest/Arousal Disorder

Edited 3/7/2024

I am speaking on behalf of the National Women’s Health Network, a non-profit advocacy organization that works to improve the health of all women. Our members support us and do not take financial contributions from drug companies, medical device manufacturers, insurance companies, or any other entity with a financial stake in women’s health decision-making.

Since the Network’s founding almost 40 years ago, we have brought women’s voices to the FDA, advocating for medical products that meet women’s real-life needs and a drug development process that reflects women’s lived experiences.

We are pleased to have the opportunity today to comment on the FDA’s efforts to develop scientifically sound guidelines for evaluating treatments for female sexual interest/arousal disorder. My comments reflect the questions, input, concerns, and perspectives of the women that the Network regularly communicates with via our Women’s Health Voice information line.

As we all know, the cultural impact and massive profitability of male impotence drugs have contributed to an equally significant interest in developing a parallel drug treatment for women. However, we must be wary of the continued trend to frame women’s sexual experience, no less than men’s, as only a performance issue. We recognize that many of our members are struggling with sexual problems and are dissatisfied with their sex lives. Still, we caution that there is a real danger in labeling all sexual problems or frustrations as “dysfunctions.” Many factors can contribute to a woman’s sexual dissatisfaction, including relationship issues, work burnout, economic anxieties, illness, past and present experiences with sexual and physical violence, and daily life stressors – just to name a few.  If product development-driven research were happening in a balanced context, proportionate attention would also be paid to the myriad of causes of women’s sexual concerns.

Despite over 15 years of concerted attention on Female Sexual Dysfunction research and development, we are still unable to identify a population of women for whom the drugs work consistently better than a placebo, perhaps in part because measures of physiological response do not adequately reflect the outcomes that matter most to women. There are many reasons that these drugs may not have been effective in increasing women’s sexual enjoyment, chief among them the heterogeneity of female sexuality and, of course, research demonstrating that sexual problems are shaped mainly by interpersonal, psychological, and social factors.

The Network has serious questions about whether drug development itself is the best way to go about addressing women’s problems with sexual satisfaction. If safe and effective drugs are going to be developed in this area, creating reliable, validated tools to capture patient-reported outcomes is essential. A more open and multidisciplinary exploration of what is driving women’s interest in female sexual dysfunction products and their definition of success would benefit everyone.

Finally, a recent public relations campaign has called for gender equality to be the FDA standard in access to sexual dysfunction treatments. This appeal is misleading and dangerous – the FDA must continue to balance a serious and respectful incorporation of patient input while maintaining a rigorous, uncompromised, science-based review standard. Women have answers to the age-old question, “What do women want?” – ask us. We want and demand products that are rigorously evaluated, safe, effective, and meet our real needs.

Cindy Pearson was the NWHN’s Executive Director from 1996 to 2021. One of the nation’s leading advocates for women’s health, Cindy often testified before Congress,  NIH and the FDA and was frequently featured in the news as a consumer expert on women’s health issues. When she retired, Cindy received a Congressional Resolution in honor of her outstanding contributions to the health of women and girls.

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