FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women
On June 13th, 2025, the U.S. Food and Drug Administration (FDA) convened a landmark roundtable: a panel of leading menopause experts, patients, and FDA officials met to discuss modernizing the official stance on hormone replacement therapy (HRT) for women. Here’s what happened and why it matters for millions.
Why This Now?
For years, millions of women suffering from menopause were told HRT was dangerous, thanks to a 2002 study (the Women’s Health Initiative, or WHI) that sparked fears of cancer and heart risk. Prescriptions dropped by half. Access all but vanished for many. Now, new science and real-world experience have cast the old warnings in a controversial new light, and the FDA is listening.
Key Takeaways From the Panel
1. A Changed Understanding of Risk and Benefit
Panelists emphasized that menopause and its symptoms—hot flashes, night sweats, insomnia, bone loss, and more—are not trivial. Untreated, they harm physical health and quality of life. HRT, started within 10 years of menopause, may actually reduce risks of heart disease, fractures, cognitive decline, and even premature death.2. The 2002 WHI Study Got Misinterpreted
Multiple experts explained that the WHI, which stopped a giant clinical trial early over fears of breast cancer and cardiac risk, mostly studied women well past menopause, often in their 60s and 70s. That doesn’t reflect the typical patient who starts HRT for symptoms in her 40s or 50s. Update: When reanalyzed, data in younger women shows clear net benefit and minimal risk.3. Not All Hormones Are Alike
“Menopausal hormone therapy” is a catchall, but route and formulation matter:- Local/vaginal estrogen for genitourinary symptoms is not systemically absorbed and does not increase risk of blood clots, heart attacks, stroke, or breast cancer.
- Systemic HRT (oral, patch, etc.) can carry risk, but that risk is tiny for most healthy women soon after menopause.
- Some forms of progestin are safer, and transdermal (patch/gel) forms have fewer side effects than pills.
4. A Harmful Black Box Warning Persists
Despite the evidence, all FDA-approved estrogen products carry a “black box” warning, designed for serious risk, often scaring away patients and doctors. Many panelists called for removing it, especially from low-dose vaginal estrogen, which has years of safety data.5. Medical Education and Access Are Lacking
Doctors receive little menopause training. Many clinicians fear prescribing HRT, and millions of women suffer needlessly. Harm, panelists said, is being done in the name of “first, do no harm.”6. Stories Matter
Patients and their advocates voiced frustration and heartbreak. Women described years of symptoms, bounced from doctor to doctor until finally receiving (and thriving on) appropriate therapy.7. The Call to Action
Panelists called for:- Updating FDA warnings and labels
- Improving access to evidence-based therapy
- Dramatically expanding provider education
- Prioritizing patient choice and individualized care