Testosterone prescriptions for U.S. women rose 146% between January 2023 and July 2026. There's still no FDA-approved testosterone product for women. The agency has reviewed the question four times and rejected it each time, citing a lack of long-term safety data. The FDA hasn't approved anything, so most insurers won't cover it. Women end up on compounded formulas or male products split into smaller doses. Today, September 17, 2026, the FDA's Office of Women's Health is holding a public workshop specifically on testosterone use in menopausal women.

1. Patients and Prescribing Clinicians (Amy Swan, Jennifer Lanoff, Magen Price, Dr. Kelly Casperson)

They say testosterone works for them, and the system is making it needlessly hard to get.

This costs patients real time. Amy Swan, a 55-year-old graphic designer near Boston, spent weeks in March 2026 just trying to fill her first testosterone gel prescription. She said: "Hours of my time were lost just being able to get this one prescription."

Clinicians say this happens constantly, not occasionally. Nurse practitioner Magen Price, founder of Mystic Valley Sexual Wellness, says more than a third of her roughly 80 testosterone patients have hit filling problems at pharmacies including CVS and Walgreens.

Being off-label doesn't mean it doesn't work, clinicians say. Jennifer Lanoff, a women's-health nurse practitioner in Washington, D.C., says clinicians have prescribed testosterone for menopausal symptoms for a long time and it works for her patients.

They want the FDA to fund real study of a female-specific formulation. Dr. Kelly Casperson, a urologist who reviewed the FDA's public comments on the workshop, says that's a better path than leaving women to improvise with male products.

2. Menopause Specialists and Medical Societies (Dr. Stephanie Faubion, Dr. Karen Adams)

They believe patients feel better, but say the evidence only backs one specific use.

The Menopause Society backs testosterone for exactly one thing. The society and several co-signing groups endorse it solely for hypoactive sexual desire disorder in postmenopausal women, not for fatigue, muscle loss, or brain fog.

Dr. Stephanie Faubion says the data isn't there for the rest. The Mayo Clinic physician, who also serves as The Menopause Society's medical director, put it directly: "We do not have any evidence in women that it will improve muscle mass or bone density or mood or well-being or really any other metric."

Stanford's Dr. Karen Adams says the safety questions are still open, too. She points to unresolved cardiovascular and breast-cancer risk, since testosterone converts to estrogen in the body.

Regulators have already said no four separate times. The FDA has reviewed testosterone therapy for women on four occasions and never approved a product.

3. Insurers and Pharmacies (Amazon Pharmacy, Kevin Schipper)

Insurers and pharmacies say they're just enforcing the FDA's own non-approval.

Insurance plans generally only cover FDA-approved indications. The FDA hasn't approved a testosterone product for women, so coverage doesn't apply by default.

Amazon Pharmacy has been turning these prescriptions away. The company has declined to fill prescriptions that require splitting a male-dosed product into a smaller female dose, redirecting patients to compounding pharmacies instead.

Pharmacists point to dosing risk, not paperwork. Kevin Schipper, a pharmacist at ProPharma, says splitting single-use, male-dosed packaging raises accuracy, stability, and contamination concerns.

Compounding costs patients more. Compounded testosterone runs about $100 for a three-month supply, versus roughly $30 for ten months of a discounted commercial product.

Where This Lands

Today's workshop runs through 4:30 p.m. Eastern to gather evidence — it won't issue a ruling. Patients and the clinicians who treat them want faster access to something they say already works. The specialists most sympathetic to them still won't extend the evidence past one narrow use. Insurers and pharmacies are just enforcing a line the FDA itself drew by never approving a product. More than 30 clinical trials on testosterone in women are underway or planned, including a Stanford pilot study due in about two years. That evidence gap isn't closing today.

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