On July 17, 2025, the U.S. Food and Drug Administration (FDA) hosted a landmark expert panel to address longstanding controversies surrounding hormone replacement therapy (HRT) for menopause. The roundtable, held at the FDA’s White Oak campus and featuring preeminent clinicians and researchers, became a focal point for debate over the future of menopause care in Read more…
Dr. Howard Hodis, professor of medicine and a landmark figure in cardiovascular research, delivered a thorough analysis of how HRT timing determines its effect profile. He explained that younger women who start hormone therapy within 10 years of menopause experience not just relief from symptoms, but reductions in all-cause mortality and cardiovascular disease incidence—benefits unparalleled Read more…
Dr. Rachel S. Rubin, fellowship-trained urologist and sexual medicine expert, used her time to elevate the discussion around genital and urinary syndrome of menopause (GSM). She shared the historical context of how the understanding of urogenital symptoms evolved, with advocacy shifting policy language toward a whole-system view of menopause. Dr. Rubin delved into the specifics Read more…
Mary Jane Minkin, MD, veteran OB/GYN and menopause educator, presented a comprehensive critique of the “one-size-fits-all” black box warning on estrogen therapies, focusing especially on low-dose vaginal products. Quoting both modern research and follow-up analyses of the WHI trial, Dr. Minkin demonstrated that fears about cardiovascular events, stroke, and breast cancer for vaginal estrogen have Read more…
Dr. Kelly Casperson brought a unique perspective as a urologist and sexual health expert, focusing attention on the regulatory and clinical neglect faced by women in need of testosterone therapy. Casperson highlighted the dramatic contrast: while dozens of testosterone products are approved and reimbursed for men, not one is formally sanctioned for use in women, Read more…
Dr. Vonda Wright, a leading authority on musculoskeletal health and aging, offered a no-nonsense appraisal of estrogen’s role in maintaining bone health after menopause. Describing osteoporosis as both prevalent and underdiagnosed, Dr. Wright noted that almost 70% of hip fractures occur in women, with one-third experiencing fatal outcomes within a year of injury. Drawing on large-scale Read more…
Roberta Diaz Brinton, PhD, a neuroscientist and international authority in women’s brain health, broadened the scope of the panel by linking menopause to the rising incidence of Alzheimer’s disease. Her presentation, at once scientific and visionary, drew a direct connection between the dramatic neuroendocrine shifts of menopause—characterized by loss of estrogen—and subsequent changes in brain Read more…
Dr. Philip Sarrel presented a compelling case for expanding hormonal therapy conversations to encompass mental as well as physical health. Citing epidemiological studies and his clinical experience, Sarrel linked untreated menopause—and its often-ignored psychological effects—to a tangible rise in healthcare utilization ranging from ER visits for insomnia and anxiety to increased rates of psychiatric medication Read more…
Dr. James Simon, an eminent clinical researcher in menopause and hormone therapy, delivered a nuanced exploration of how the timing of hormone replacement profoundly influences outcomes. He synthesized years of clinical trial data and real-world studies to illustrate a clear pattern: early initiation of HRT, within 10 years of menopause onset or before age 60, Read more…
Dr. JoAnn Pinkerton, a prominent leader in gynecology and menopause care, presented a passionate and evidence-back call to overhaul FDA boxed warnings on hormonal therapies. With a focus on patient rights and physician guidance, Dr. Pinkerton argued that millions of women are disenfranchised from effective treatments by outdated regulatory language that is not aligned with Read more…
Dr. Barbara Levy, a renowned gynecologist and specialist in women’s health, spoke with urgency about the need to update FDA warnings on hormone therapy for menopausal women. Levy outlined how the now-infamous black box warning, which was attached after the Women’s Health Initiative (WHI) study in 2002, continues to limit access to HRT despite significant Read more…
Dr. Heather Hirsch’s presentation powerfully challenged longstanding dogma around hormone therapy (HRT) for menopause. Citing her experience as an internist with advanced women’s health training, Dr. Hirsch opened by recounting patient stories that highlighted the real-world harm caused by excessive caution and misinformation about HRT. One poignant story told of “Denise,” a patient who, during Read more…
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