While sexual dysfunction affects both men and women, men have 26 FDA-approved treatments to choose from. Women have one.
Why is there no female Viagra?
A new documentary explains that it’s in part because the FDA drug approval process determines which sexual health options are available, and how restrictions or labeling decisions can limit access for certain groups.
“When you look at women — premenopausal, postmenopausal, transgender individuals — the conversation of what is available to you is not dictated by you,” explains Johns Hopkins Carey Business School Law and Ethics Professor Stacey Lee in The Pink Pill: Sex, Drugs & Who Has Control.
Addyi, or flibanserin, treats Hypoactive Sexual Desire Disorder, a common condition defined by lack of sexual desire in women. It has yet to achieve the same kind of widespread use or acceptance as men’s Viagra, which is used by millions of patients annually since its 1998 debut.
The Pink Pill recounts the journey of Sprout Pharmaceuticals Founder and CEO Cindy Eckert, the entrepreneur whose company developed and brought Addyi to market, as she set out to expand access for sexual health treatments for women. Eckert’s path in developing Addyi for patient use was more of a struggle than it should’ve been, according to the documentary, which calls out the inequalities in availability of sexual health treatment between men and women.
Lee highlights that FDA choices and approvals are not just regulatory decisions, but that they also shape who can get care and how easily.
“If you’re a cisgender, white male, healthcare in the United States is pretty darn good, and your healthcare experience can be a uniquely personal one,” she said. In other words, women and minority groups often don’t have a similar, positive experience.
“FDA decisions are not just scientific determinations, but structural choices that shape access, risk, and who benefits from innovation,” said Lee.
Why the FDA rejected Addyi twice
The FDA declined approval for Addyi in 2010 and 2013, with some critics referring to the treatment as “an ineffective drug for a nonexistent problem.” However, data from the University of Colorado Anschutz Department of Obstetrics and Gynecology shows that 10% of women across all age groups suffer from HSDD, which can “cause significant levels of personal distress.”
To put it into perspective, HSDD is just as common as autoimmune disorders like rheumatoid arthritis, and in the U.S. alone there are nearly a million patients taking oral medication to treat their autoimmune condition. Though HSDD is not a threat to physical wellbeing, both conditions can have significant impact on a person’s life. Like most medications, Addyi doesn’t work for everyone, but its availability gives women struggling with HSDD an option that otherwise doesn’t exist.
Still, early research didn’t quite satisfy the FDA.
“When the data first went up for review in 2010, the FDA did not feel that there was enough data to support Addyi’s effectiveness,” said Lee.
The drug was originally tested in a clinical trial with over 2,000 premenopausal women either taking Addyi or a placebo pill. Participants taking Addyi were 10% more likely to report an increase in satisfying sexual events. A more recent study found that about half of women taking Addyi reported benefit to their sex life.
How FDA decisions shape access
Advocates for women’s health criticized the FDA’s early rejections and claimed gender bias, especially because Viagra was approved under an expedited priority review process, taking less than a year to achieve approval. Though the purposes of Addyi and Viagra are similar, Addyi corrects chemical imbalances of certain neurotransmitters in the brain that are responsible for sexual desire or excitement, which makes the drug approval process more complex.
“Erectile dysfunction was seen as an unmet physical ailment,” said Lee. Because of that, Viagra was evaluated as treatment to address a physical need.
HSDD was not considered an unmet physical ailment in the eyes of the FDA but rather an unmet psychological ailment, which “immediately triggers a higher standard of review and additional safety measures,” Lee adds.
While the drugs had to be evaluated differently, supporters of Addyi claimed that stigma and overly cautious FDA warnings deterred patient use even after it was approved.
For example, doctors and pharmacists had to take a test, known as a Risk Evaluation and Mitigation Strategy assessment, to prescribe and administer Addyi. The assessment included an online slide presentation followed by a comprehension test that proved the medical professionals knew and understood the drug’s risks of potential low blood pressure and fainting when combined with alcohol.
Even further, patients had to sign a paper vowing not to drink while on the medication even though Cialis--another medication used to treat erectile dysfunction in men--creates similar interactions with alcohol but comes with no more than an advisement to moderate alcohol use. At the time of approval, the FDA argued that Addyi’s interaction with alcohol hadn’t yet been adequately studied.
In 2019 and after additional research was conducted, the FDA modified its original alcohol warning for Addyi and removed the test requirement for doctors and pharmacists. In December of 2025, the FDA approved the drug for postmenopausal women, expanding access to more patients.
Advocates say a drug to treat women’s sexual dysfunction is a start to addressing health inequity. Lee adds that recent bigger picture events, though, like the overturn of Roe v. Wade and rollbacks on birth control access, have changed what healthcare looks like for women today. The approval and acceptance of Addyi is part of a much larger and ongoing conversation about women’s health and regulatory policy currently.
“The past five to 10 years really calls into question where the state of women’s health is going,” Lee said.
The Pink Pill: Sex, Drugs & Who Has Control is streaming on Paramount+ in Canada and the U.S. as of March 6, 2026.
FAQs in this article:
- What is “female Viagra”?
- Why was Addyi controversial?
- Is Addyi effective?
