For years, one question has come up in my clinic almost weekly: “What about testosterone?” And for years, the honest answer has been the same: the evidence supports it for one specific problem, no product is made for women, and the system makes it needlessly hard to get.
Yesterday, the FDA spent an entire day on exactly this. It’s worth paying attention.
What happened
On September 17, the FDA held its first-ever public workshop on testosterone use in menopausal women - a full day, in person and online, with regulators, researchers, clinicians, and patients in the room. The agency’s own framing: examine what’s known, map what’s missing, and chart a path toward testosterone products actually developed for women.
The timing tells the story. Testosterone prescriptions for US women have nearly tripled since 2023 (up 146%), yet there is no FDA-approved testosterone product for women, at any dose, for any condition. Doctors prescribe off-label: splitting gels designed for men, or turning to compounding pharmacies. Insurance rarely covers it, and pharmacies have started delaying or refusing these prescriptions. Meanwhile the UK, Australia, New Zealand, and South Africa all approve testosterone for women with low sexual desire.
The FDA’s public comment docket drew 744 submissions before the meeting, many from women describing what the treatment changed for them.
What was said
The headline moment came from the government’s own officials. The Assistant Secretary for Health, Admiral Brian Christine, opened by calling it unacceptable that American women have no approved testosterone product while Australian women do: “Something’s wrong with that,” he said, urging the FDA to “get this done.” The deputy director of the NIH’s child health and human development institute added that women deserve options “formulated and dosed specifically for them.” And FDA officials told manufacturers directly: we stand ready to review applications for female-specific products, and data from products already approved overseas can count, case by case.
The clinicians brought the balance. Dr. Rajita Patil, who directs UCLA’s comprehensive menopause program, was precise: the evidence today supports testosterone for one condition - hypoactive sexual desire disorder (HSDD), persistently low sexual desire that causes distress - and not for mood, cognition, or general well-being. She also warned against oral testosterone, which worsens cholesterol profiles. Others in the room pointed out the double standard: GLP-1 weight-loss drugs won multiple approvals without decades of safety data, while women’s sexual health waits.
The plain-English meaning
Testosterone in women declines steadily with age - by the late 40s, levels are roughly half of what they were in the early 20s. For some women that shows up as a loss of sexual desire that nothing else touches. For those women, low, female-appropriate doses are the one treatment with real evidence behind it, and it’s what international menopause guidelines endorse.
What’s broken isn’t the science - it’s the infrastructure. A woman needs a fraction of the male dose, but no product comes in that dose, so patients eyeball portions of a man’s gel packet. Pharmacists balk. Insurers say no. An approved female product fixes all of it: standard dosing, proper labeling, safety monitoring, and a fighting chance at coverage.
What you gain from this
Nothing changes at the pharmacy today. This was a workshop, not an approval. But the direction is unmistakable: the FDA is openly inviting manufacturers to bring female-specific products forward.
Your voice is literally on the record. The FDA’s public comment period stays open until October 19. If testosterone has mattered in your life, good or bad, the agency is asking to hear it: https://www.regulations.gov/commenton/FDA-2026-N-5479-0001
If you’re prescribed testosterone now, two questions worth asking your doctor: is the goal HSDD (the evidence-backed use), and is the dose a physiologic female dose rather than a scaled-down male one?
The honest caveats
The evidence supports testosterone for HSDD. Full stop. The energy, muscle, bone, mood, and general “wellness” claims filling social media do not have the data yet - the experts at the meeting said so explicitly.
Long-term safety beyond two years is unknown, especially for cardiovascular health and breast cancer. Testosterone converts to estrogen in the body, which is why it’s generally avoided in women with a history of breast cancer.
Excessive doses bring real side effects: acne, increased hair growth, and rarely voice deepening or hair loss that don’t reverse.
This is exactly why testosterone belongs with a physician who measures levels and follows you - not a wellness clinic selling pellets.
My take
I’ve watched women piece together testosterone therapy from products designed for someone else’s body, at doses they have to estimate, paid out of pocket, while four other developed countries simply approve it. Yesterday’s meeting doesn’t change a prescription pad today. But it’s the first time the FDA has said out loud that this gap is a problem to solve rather than a situation to tolerate. That’s how approvals start.
Dr. Herman Weiss
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