As an avid women’s health advocate, I’m excited to share a detailed summary of the groundbreaking FDA Women’s Health Roundtable on Hormone Replacement Therapy, held on July 16, 2025.
This event signals a long-overdue and meaningful shift in how menopause care is being addressed at the national level—for both the women experiencing it and the practitioners guiding them through it.
Those of us in the functional and integrative space have been advocating for years what both research and real-world results have made clear: when used safely and intentionally, bioidentical hormone therapy has the power to dramatically improve lives.
This FDA roundtable represents more than just policy talk—it’s a bold acknowledgment that women’s health deserves better, and that it’s time to rebuild trust in evidence-based hormone care.
I strongly encourage fellow providers to stay informed and engaged—because the momentum is building, and we are part of the movement driving it forward.
FDA Women’s Health Roundtable: Hormone Replacement Therapy (HRT) and Women’s Health Summary
Date: July 17, 2025
To watch the roundtable:
https://www.youtube.com/live/_2ZRlOivC5M?si=4neXibMRa6NBfmYM
On July 17, 2025, the U.S. Food and Drug Administration (FDA) convened a landmark roundtable of leading clinicians, researchers, public health experts, and patient advocates to reevaluate the safety, efficacy, and public perception of Hormone Replacement Therapy (HRT), particularly estrogen therapy for menopausal women. The forum was a response to the growing movement for evidence-based menopause care and renewed scrutiny of longstanding FDA labeling practices that may no longer reflect the current body of clinical data.
Central to the day’s dialogue was a resounding call to correct misconceptions propagated by the 2002 Women’s Health Initiative (WHI), which many panelists deemed outdated and methodologically flawed. Emphasis was placed on the “critical window” theory—that estrogen therapy, when initiated within 10 years of menopause, confers significant benefits in cardiovascular health, bone preservation, and cognitive protection. The panel urged the FDA to update its black box warnings, support continuing medical education (CME) in menopause care, and open a formal public comment period.
- Chronological Narrative of Key Proceedings
Opening Remarks
- FDA leadership welcomed over 400 attendees, including remote participants, emphasizing the agency’s commitment to women’s health and open regulatory dialogue.
- Speakers acknowledged the lack of education, access, and clear clinical guidance on menopause treatment.
- The session was introduced as part of a broader commitment to improve regulatory frameworks and empower patients with evidence-informed options.
Dr. Marty Makary – Cardiovascular Evidence and Historical Perspective
- Dr. Makary cited Mayo Clinic findings from the 1950s on oophorectomized women who exhibited dramatically higher rates of cardiovascular disease.
- Reviewed multiple studies showing 30–50% reductions in heart disease risk when estrogen is initiated during the early menopausal transition.
- Highlighted 2015 data showing a 26% spike in cardiovascular events after abrupt discontinuation of HRT.
- Compared estrogen’s cardioprotective benefits to those of statins, framing estrogen as a “life-saving preventive therapy” in the right population.
Debunking the WHI Study
- Several panelists critiqued the WHI’s design, including its average participant age of 63, more than a decade post-menopause.
- The WHI tested oral conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA), now considered suboptimal or outdated.
- Experts emphasized the importance of differentiating outcomes by age, route, and formulation, all of which influence risk profiles.
- Discussed downstream consequences of the WHI: mass HRT discontinuation, surge in antidepressant prescriptions, and rise in fracture and cardiac events.
Clinical Evidence and Case Examples
- Dr. Ekta Kapoor (Mayo Clinic) and Dr. Rachel Rubin (George Washington University) presented case studies of women with severe menopausal symptoms misdiagnosed and undertreated.
- Examples included women being prescribed SSRIs or sleep aids instead of hormonal therapy, leading to years of avoidable suffering.
- Discussed transdermal estradiol and vaginal estrogen as safer, evidence-backed options.
- Endorsed individualized care based on patient history, goals, and risk assessments.
Patient Perspectives
- Multiple women spoke candidly about the psychological and physical toll of untreated menopause—anxiety, sexual dysfunction, bone loss, and sleep disruption.
- Some recounted begging providers for help, only to be dismissed or prescribed mood stabilizers.
- A consistent theme: relief and restoration upon starting HRT, often after years of fruitless treatments.
- Patients advocated for greater provider education and more inclusive, trauma-informed care.
Regulatory Challenges and Black Box Warnings
- Clinicians criticized the black box warnings on estrogen products as overly broad, outdated, and fear-inducing.
- Noted that warnings reflect findings from WHI-era drugs rather than modern formulations.
- Urged FDA to create age- and route-specific warnings that distinguish between transdermal vs. oral and systemic vs. local therapy.
- Requested incorporation of newer trials like KEEPS, ELITE, and Danish Osteoporosis Prevention Study.
Health Equity and Clinical Training Gaps
- Highlighted the absence of menopause training in most U.S. medical schools and residency programs.
- Called for CME certification pathways, integrated menopause modules in OB/GYN and primary care tracks.
- Addressed racial and socioeconomic disparities in diagnosis and treatment—particularly among Black and Hispanic women.
- Suggested expanding telehealth and funding public awareness campaigns in multiple languages.
Closing Remarks and FDA Commitments
- Dr. Kaveeta Vasisht and FDA officials thanked the panelists and participants, acknowledging both the scientific complexity and human urgency of the issue.
- Announced an official Federal Register notice to invite public comments on HRT labeling.
- Committed to re-reviewing scientific data and stakeholder submissions to guide future label changes and public guidance.
- Detailed Topical Breakdown
- Cardiovascular Health
- Estrogen preserves arterial compliance, reduces inflammation, and improves lipid profiles.
- Studies suggest 30–50% reduction in coronary events if initiated within 10 years post-menopause.
- Transdermal routes preferred due to lower thrombotic risk.
- Bone Health and Osteoporosis
- Estrogen inhibits osteoclast activity, preventing bone loss.
- Proven to reduce vertebral and non-vertebral fractures in randomized trials.
- Early HRT initiation improves long-term skeletal outcomes.
- Cognitive Function and Dementia
- Early estrogen use may reduce Alzheimer’s risk; later use may not confer benefit.
- Neuroimaging studies show brain volume preservation and improved cerebral perfusion in early users.
- Timing of initiation is critical (“critical window hypothesis”).
- Breast Cancer and Risk Perception
- WHI showed reduced breast cancer risk with estrogen-alone therapy (CEE only arm).
- Experts urged contextualizing risks relative to lifestyle factors (e.g., alcohol, obesity).
- Clarified that progestin—not bioidentical progesterone—was associated with higher risk.
- Labeling Reform
- Black box warnings reference outdated or non-representative populations.
- Proposed dynamic labels based on age, route, and formulation.
- Requested incorporation of real-world evidence and newer randomized trials.
- Clinical Education and Misdiagnosis
- Menopausal symptoms are often misdiagnosed as psychiatric conditions.
- Medical curricula lack structured menopause training.
- Proposed CME programs and provider toolkits.
- Health Equity and Access
- Language barriers, systemic racism, and socioeconomic status impact care.
- Urged culturally competent approaches, mobile clinics, and Medicaid coverage of HRT.
- Emphasized patient-led advocacy groups and storytelling campaigns.
- Key Quotes and Soundbites
“This isn’t about vanity or anti-aging. It’s about survival and quality of life.”
— Dr. Rachel Rubin
“Estrogen, when timed correctly, is one of the most powerful disease prevention tools we have.”
— Dr. Marty Makary
“For years, I thought I was losing my mind. What I needed was estrogen.”
— Patient Advocate
“Let’s modernize the label to reflect modern science.”
— FDA Roundtable Clinician
- Next Steps and Call to Action
- FDA to open Federal Register public comment period for formal stakeholder input.
- Providers, patients, researchers encouraged to submit data, personal stories, and literature reviews.
- Future regulatory revisions will be informed by new evidence and lived experience.
- Suggested follow-up: national summit, CME curriculum development, bipartisan legislative support.
