FDA Expert Panel: The Truth About Menopause & Hormone Therapy
This is a summary of the Expert Panel on Menopause & Hormone Replacement Therapy for Women,” recently convened with the new FDA Commissioner, Dr. Marty Makarty, MD on July 17, 2025.
Why 50 Million Women Have Been Denied Lifesaving Care
For over 20 years, millions of women have been denied access to safe, effective hormone therapy because of fear — not facts.
The FDA’s outdated black box warnings on estrogen-based treatments, based on flawed interpretations of the 2002 Women’s Health Initiative (WHI) study, have kept patients and clinicians in the dark.
The Facts the FDA Can’t Ignore
No credible clinical trial has ever shown that hormone therapy increases breast cancer mortality.
Timing matters: Starting estrogen therapy within 10 years of menopause or before age 60 can reduce risk of fatal heart attacks by up to 50%, lower Alzheimer’s risk by 35–64%, and cut bone fractures nearly in half.
Vaginal (local) estrogen is categorically safe — it does not enter the bloodstream in measurable amounts and carries no increased risk for heart disease, stroke, clots, dementia, or breast cancer.
The WHI data was misinterpreted — the average participant was 63 years old, using outdated synthetic hormones. Younger women and those using bioidentical estradiol have far better outcomes.
The Cost of Fear
Since 2002, avoidance of estrogen therapy has contributed to at least 150,000 unnecessary deaths in U.S. women in their 50s and 60s.
Hip fractures from preventable osteoporosis carry a 30% one-year mortality rate — and estrogen is the only proven intervention to stop the steep bone loss of early menopause.
UTIs, sexual dysfunction, and loss of vitality devastated quality of life — and could often be prevented with low-cost local hormone treatments.
Real Women, Real Harm
Denise: Plunged into perimenopause, awoke in the night with suicidal thoughts — a direct result of untreated hormone loss.
Miriam: Broke her hip in her kitchen, never offered vaginal estrogen despite chronic UTIs, heart damage, and bone loss.
Doctors’ own mothers and sisters — denied therapy — suffered fractures, cognitive decline, and preventable disability.
The Expert Consensus
From leading menopause specialists, urologists, neurologists, orthopedic surgeons, and women’s health advocates:
Remove the outdated black box warnings from low-dose vaginal estrogen.
Modernize labeling for systemic hormone therapy to reflect timing, formulation, and delivery method.
Approve female-dose testosterone to treat the same deficiency recognized in men.
Expand menopause education for all healthcare providers, including NPs, PAs, and pharmacists.
The Bottom Line
The current FDA labels are not only unscientific — they are harming women every single day.
Updating these warnings and policies could save lives, prevent disability, and restore vitality to millions.
Women deserve policies based on evidence — not fear.
It’s time to separate medical dogma from the truth.
