The Day the FDA Listened: What This Historic Menopause Panel Means for 50 Million Women

Hello Warriors!

This week, history was made.

On July 17th, 2025, the FDA hosted a landmark expert panel — the first of its kind — devoted entirely to menopause and hormone therapy. Gathered in a packed auditorium at the FDA’s White Oak headquarters, a powerhouse lineup of physicians, researchers, and advocates spoke with one voice: Women have been misled and underserved for too long.

The session wasn’t just about science. It was about equity, access, safety — and correcting two decades of fear-based messaging that started in 2002 with the fallout from the Women’s Health Initiative study. The panel challenged outdated "black box" warnings on estrogen, called for FDA approval of female-dose testosterone, and demanded that evidence, not fear, guide future policy.

The implications for every woman — and every clinician — are enormous.

7 Truth Bombs from the FDA Menopause Panel That Could Change Everything

1. The black box warning on vaginal estrogen must go

Multiple experts presented overwhelming data showing that low-dose vaginal estrogen is safe and does not raise the risk of stroke, heart disease, or cancer. The warning is outdated, unscientific, and harms women by fueling fear.

2. Estrogen therapy can save lives — and reduce suffering

Data shows up to a 50% reduction in fatal heart attacks when estrogen is started within 10 years of menopause. It also improves bone strength, cognitive function, and quality of life.

3. We misunderstood the WHI study for decades

Experts clarified that the WHI enrolled older women (average age 63) using high-dose oral estrogen. Today’s low-dose, transdermal, or vaginal forms are far safer when started earlier — yet current warnings still reflect outdated risks.

4. The education gap among doctors is huge

Several physicians confessed they received only an hour of menopause training — often as an optional lunch lecture. Meanwhile, patients are going to 5–7 doctors before getting relief

5. Vaginal and systemic hormones are not the same

Local estrogen does not enter the bloodstream in meaningful amounts. Yet both forms share the same label, leading to confusion among patients and clinicians.

6. Testosterone for women is a missing piece

There is no FDA-approved female-dose testosterone in the U.S., despite mounting evidence it improves energy, mood, cognition, and libido. Four other countries already have approved versions for women.

7. Denying hormone therapy has consequences

Yale researchers estimate over 150,000 avoidable deaths since 2002 from not using estrogen post-hysterectomy — all linked to fear, confusion, or lack of access.

Meet the Panel: The Experts Who Spoke Up for You

• Dr. Marty Makary – Commissioner, FDA
  Health policy leader who convened the roundtable and compared estrogen’s benefits to statins in heart health.

• Dr. Sara Brenner – Principal Deputy Commissioner, FDA
  Public health advocate committed to evidence-based reform for women’s health.

• Dr. Heather Hirsch – Internist, Menopause Specialist
  Cleveland Clinic–trained menopause expert who called out medical dogma and misinformation.

• Dr. Barbara Levy – OB/GYN, ACOG Leader
  Spoke about the trauma from the 2002 WHI fallout and the biological differences between hormone types.

• Dr. JoAnn Pinkerton – Past President, North American Menopause Society (NAMS)
  Brought critical WHI data and emphasized proper age-based interpretation.

• Dr. James Simon – Reproductive Endocrinologist
  Called the FDA’s vaginal estrogen labeling inconsistent and unsupported by data.

• Dr. Philip Sarrel – Yale Professor Emeritus
  Presented stunning data on reduced workplace performance and increased mortality due to untreated hot flashes.

• Dr. Roberta Diaz Brinton – Neuroscientist, University of Arizona
  Explained how estrogen protects the aging brain — especially in preventing Alzheimer’s.

• Dr. Vonda Wright – Orthopedic Surgeon
  Described estrogen’s role in preventing osteoporosis and her frustration over preventable hip fractures.

• Dr. Kelly Casperson – Urologist & Advocate
  Made a powerful case for fast-tracking female-dose testosterone, drawing sharp contrasts with male access.

• Dr. Mary Jane Minkin – OB/GYN & Educator
  Exposed the collapse of menopause education in medical schools post-WHI.

• Dr. Rachel Rubin – Urologist, Sexual Medicine Expert
  Shared a personal story about how FDA labeling almost cost her mother’s life in the ICU.

• Dr. Howard Hodis – Cardiologist and Researcher
  Presented long-term WHI data showing estrogen reduces all-cause mortality and does not raise breast cancer risk in younger women.

• Dr. Dorothy Fink – Deputy Assistant Secretary of Health, HHS
  Spoke on early menopause, POI, and the critical need for access to testosterone for women under 40.Listen to the FULL EPISODE now!

Why This Moment Matters

This panel marks the beginning of a long-overdue shift — one that could empower millions of women with accurate, evidence-based options for midlife and beyond. If the FDA acts on this panel’s recommendations, we may finally see:

• Updated drug labels that reflect current science

• Increased access to low-risk treatments

• A generation of doctors trained in menopause care

• And most importantly, women who are heard, helped, and healed.

Stay tuned, warriors. This is just the beginning.

With power and purpose,
Crissy

Ready to Warrior Up!

Listen to the Full Episode: Suburban Warrior podcast on Apple Podcasts or wherever you get your podcasts.

Thank you for reading—and remember, knowledge is power! If you’re experiencing symptoms, don’t ignore them. There is help (and hope) out there. Stay tuned for our next newsletter to keep transforming your mindset and rocking your inner warrior!