WASHINGTON, D.C. — For the first time in more than two decades, the Food and Drug Administration will convene an expert panel today to revisit the safety profile of menopausal hormone therapy—an issue that has ricocheted between optimism and alarm since the early 2000s.
Commissioner Marty Makary, an outspoken critic of what he calls “stale dogma,” ordered the review, arguing that newer evidence paints a more nuanced picture of estrogen-based treatment. Makary maintains that when therapy begins within a decade of a woman’s final period, benefits may extend beyond hot-flash relief to potential protection against osteoporosis, cardiovascular disease, and even cognitive decline. Medical Xpress
From Mainstay to Marginalized
Hormone therapy was once the standard of care for menopausal symptoms, but usage cratered after the Women’s Health Initiative halted a large clinical trial in 2002 over elevated risks of invasive breast cancer, stroke, and clots. Critics have since faulted that study for enrolling women many years past menopause and for relying on drug formulations rarely prescribed today. National Center for Health Research
A Polarized Panel
Today’s roster includes researchers who believe the original warnings were overstated and clinicians who insist the caution label saves lives. Several panelists advise advocacy groups pushing to soften the FDA’s black-box warning on estrogen products, while others warn that aggressive promotion could downplay rare but serious harms. Constant Contact
Transparency Questions Linger
In a departure from pre-Trump protocol, the FDA released scant agenda details ahead of the session, irking watchdogs who note that some speakers have commercial ties to menopause-therapy startups. Patient-safety advocates argue the agency must insulate scientific deliberations from marketing pressure to avoid “regulatory capture.” National Center for Health Research
What’s at Stake
- Clinical Practice: Family physicians and gynecologists are seeking updated guidance to reconcile diverging studies and to decide whether modern, lower-dose regimens warrant a different risk-benefit calculus.
- Public Health: Roughly 45 million U.S. women will reach menopause in the next decade. Even marginal shifts in prescribing could affect millions of patient-years of exposure.
- Industry Signals: A friendlier label could accelerate investment into next-generation hormone patches, micro-dosed gels, and precision-dosed pellets now in early-stage trials.
Next Steps
The advisory committee’s recommendations are non-binding, but the agency traditionally heeds its panels on contentious matters. Should the FDA adjust its warning language or dosage guidance, insurers will likely follow suit—potentially reshaping a multibillion-dollar therapeutic category overnight. A decision is expected later this year after a formal comment period.
For menopausal women navigating a maze of conflicting headlines, today’s session may finally clarify whether hormone therapy is an underused tool or a medical misstep best left in the past.
