“There may be no other medication in the modern era that can improve the health outcomes of women on a population level than hormone replacement therapy.”
— Dr. Marty Makary, FDA Commissioner, Nov. 10, 2025
Why This FDA Announcement Changes Everything
On November 10, 2025, the FDA, led by Commissioner Dr. Marty Makary, made history by removing the black box warning from hormone replacement therapy (HRT) for menopause. For millions of American women, this is more than a regulatory change—it’s a long-awaited recognition of science, and a new era in women’s health.
“The era of ignoring women’s health is over. The era of patronizing women is over. The FDA will follow the science and America’s women will finally get the care, the respect, and the honesty that they deserve.”
— Secretary Robert F. Kennedy Jr.
The Myth That Changed Medicine — And Why It Was Debunked
For over twenty years, women were told to fear HRT based on the 2002 Women’s Health Initiative (WHI) study. Despite the media frenzy, the study’s headline that “HRT causes breast cancer” was not supported by the actual data.
Dr. Makary explained:
“The headline was released to the media before the scientific data was released to the public. A week later, once the data was published, some of us looked at it and said, ‘There’s no statistical significance. If we don’t have statistics, then we don’t have science.'”
He added that women who took estrogen alone had a 24% reduction in breast cancer and that no clinical trial has ever shown HRT increases breast cancer mortality.
Before the fear, one in four women used HRT. Today, fewer than one in twenty use it.
“Before the panic, one in four women used hormone replacement therapy. Today, it’s fewer than one in 20. That’s not progress. That’s neglect. That’s malpractice.”
— Secretary Robert F. Kennedy Jr.
HRT: Life-Changing Benefits, Backed by Science
HRT is not just about relieving hot flashes. Research shows it saves lives, extends healthy years, and helps women thrive physically, cognitively, and emotionally.
Major Benefits of HRT:
- Cardiovascular Health: Reduces risk of cardiovascular disease and mortality by up to 50%.
- Cognitive Protection: Reduces Alzheimer’s risk by 35%.
- Bone Strength: Reduces bone fractures by 50–60%.
- Quality of Life: Improves sleep, mental clarity, and overall well-being.
HRT alleviates severe menopausal symptoms in over 80% of women.
Why Was This Denied For So Long?
Dr. Makary emphasized the systemic issues behind the decades-long resistance to HRT:
“A male-dominated medical profession has minimized the symptoms of menopause. And as a result, women’s health issues have not received the attention they deserve.”
He cited the power of groupthink and referenced evidence from over 40 studies showing:
- 30–50% reduction in heart disease
- 30% reduction in all-cause mortality
- 48% reduction in heart attack deaths
Restoring Trust and Changing Lives
The FDA announcement finally validates what women and menopause experts have advocated for years. This decision is about respecting women, following rigorous science, and restoring the doctor-patient relationship.
“We are listening to women who have been challenging the paternalism of medicine. We are listening to doctors who have been waving the flag in the air saying, ‘Hey, we have this wrong.’ This administration hears your voice and is not afraid to challenge the medical status quo.”
— Dr. Marty Makary
The Road Forward
As Dr. Makary stated:
“There may be no other medication in the modern era that can improve the health outcomes of women on a population level than hormone replacement therapy.”
With this historic announcement, hope, science, and integrity are restored—and millions of women can finally reclaim their health and quality of life.
Sources
- FDA Press Conference, Nov. 10, 2025
- Women’s Health Initiative (WHI), 2002
- FDA/HHS Press Releases (2025)
- Peer-reviewed studies cited during the announcement
- Major meta-analyses in NEJM, Circulation, JAMA, and Cancer