Major Policy Shift Expected to Expand Treatment Access for Millions of Women
In a landmark decision, the U.S. Food and Drug Administration (FDA) announced plans to remove the long-standing “black box” warning from many menopausal hormone therapies, marking a dramatic shift in women’s health policy after two decades of caution and controversy. The move is expected to increase confidence among physicians and patients and spark a surge in prescriptions for hormone replacement therapy (HRT).
The black box warning—introduced in 2003 following the Women’s Health Initiative (WHI) study—linked hormone therapy to heightened risks of cardiovascular disease, stroke, breast cancer, and dementia. Those warnings caused prescriptions to plummet more than 70% over the next decade. Now, with new evidence and mounting expert pressure, the FDA says it is ready to rewrite that narrative.
“After 23 years of dogma, the FDA is announcing that we are going to stop the fear machine steering women away from this life-changing, even life-saving, treatment,” said Dr. Marty Makary, the FDA Commissioner. “With the exception of vaccines or antibiotics, there’s no medication that can improve the health of women on a population level more than hormone replacement therapy.”
New Labeling Reflects Modern Research and Individualized Risks
Under the updated guidance, hormone therapy will be recommended primarily for women younger than 60 or within 10 years of menopause, when benefits are considered highest and risks lower. The FDA will also eliminate the old directive to use “the lowest effective dose for the shortest time,” a change that could allow long-term use under medical supervision.
FDA officials emphasized the importance of personalized care, noting that risks still exist for women with prior breast cancer or clotting disorders. “We want doctors to have the right information,” Makary said. “Part of that means removing these scary warnings and putting the nuanced discussion in the package insert instead.”
The label revision process could take several months, but Makary said drugmakers are “very excited” about the change. Experts believe this will restore confidence among clinicians who had grown wary of prescribing HRT after the WHI study.
Experts Praise the Decision as a Long-Overdue Correction
Women’s health leaders broadly welcomed the FDA’s move as a long-awaited acknowledgment of the latest science. Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women’s Hospital, called the change “overdue and well-supported.” She added, “The existing boxed warning is one-size-fits-all—it doesn’t account for age, type of hormone, or delivery method.”
Similarly, Dr. JoAnn Pinkerton of the University of Virginia said, “Removing the boxed warning from local vaginal estrogen is a victory for women’s health. The FDA’s nuanced approach to systemic hormone therapy is equally important, though discussions must remain individualized.”
The Menopause Society and other advocacy groups have petitioned the FDA for years to reconsider the warning. “This is a step toward modernizing menopause care,” said Jennifer Weiss-Wolf, executive director of the Birnbaum Women’s Leadership Center at NYU. “It’s part of a larger movement ensuring menopause is treated with accuracy, equity, and dignity.”
Restoring Confidence in Hormone Therapy
Before the 2003 warning, roughly one in four postmenopausal women used hormone therapy for symptoms like hot flashes, insomnia, and mood changes. By 2020, that figure had dropped to about one in twenty-five. The resulting undertreatment, experts argue, has deprived millions of women of relief and contributed to declining midlife health outcomes.
“Hormone therapy is not just symptom management—it’s preventive medicine,” said Dr. Erika Schwartz, a New York-based internist. “The fear around cancer risk has been exaggerated for decades. We now know that, for many women, hormones can protect against heart disease, osteoporosis, and cognitive decline.”
Recent studies confirm that when started early, hormone therapy can safely improve cardiovascular and neurological health. Dr. Jayne Morgan, a cardiologist and women’s health expert, explained: “Estrogen is fuel for the body—it powers the heart, brain, and bones. Once that fuel runs out, the body begins to struggle. Restoring it can dramatically improve quality of life.”
A Broader Movement in Women’s Health
The FDA’s action aligns with a wave of state-level menopause legislation expanding access to care, training clinicians, and improving insurance coverage. Nineteen states have introduced more than 35 bills addressing menopause awareness and treatment.
For advocates and clinicians, the policy change represents both a scientific correction and a cultural turning point. As Weiss-Wolf put it, “We are witnessing menopause come out of the shadows.”