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After more than 20 years, the FDA announced in November 2025 that it would begin the process of removing the black box warning from Menopausal Replacement Therapy, which had been mandated to be included on products beginning in 2003. The warning language highlighted what was believed to be the connection between MRT and longer-term health risks for the women taking it—discouraging many women from using this front-line treatment for menopause symptoms.
In March of this year, I had the opportunity to attend U.S. Department of Health and Human Services Office on Women’s Health’s first HHS National Conference on Women’s Health in Washington, D.C. The meeting included scientific posters, panels on new science, policy approaches and collaboration between business and government. Speakers included key government officials, researchers, entrepreneurs, investors representing a range of asset classes, health care practitioners, chief medical officers and partnership drivers, as well as many others.
One of the frequent conversations in healthcare—and women’s health specifically—is how complex and time-consuming it is to make real, meaningful change that results in improved outcomes. So I was particularly excited by the first panel I heard titled "Beyond the Black Box Warning: The Critical Role of Estrogen in Women’s Urological Health” with Marisa Clifton, M.D. and Rachel Rubin, M.D., as it provided real details about just the kind of change we have been working toward.
The change to the black box warning was the results of decades of work, advocacy, thought leadership, industry involvement and clarification of scientific study results. Health care practitioners, women’s health advocates and the broader women’s health ecosystem seemed to applaud the changes. To understand the magnitude of this change, it is important to understand where we were and how we got here.
As per Dr. Rubin, the process was long, time-consuming and challenging, and will continue to require multiple steps, warriors and resources to make a true clinical impact. Each step built upon the previous.
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In 2002, results from the Women’s Health Initiative study, which originally began in 1993, were published. The study was designed to determine whether combination hormone therapy (Experiment 1) or estrogen only therapy (Experiment 2) helped prevent the incidence of chronic diseases in post-menopausal women. Previous research had indicated that women taking estrogen experienced significantly lower rates of heart disease.
The combination therapy study—Experiment 1—was halted 3 years early when the data analysis indicated that women in the study were at increased risk in 6 critical areas—breast cancer heart attack, stroke, blood clots, colorectal cancer and hip fractures.
In 2003, the black box warning language was added to all related hormonal therapy—estrogen only, combination therapy and vaginal estrogen. Overnight, prescription rates declined, patient anxiety increased—and as a result, the treatment paradigm shifted dramatically. Hormone therapy usage declined precipitously from 26.9% in 1999 to 4.7% in 2020 as a result of the reported study results and warning language.
Fortunately, during the confusion and uncertainty about hormone therapy for menopausal women, the field did not stand still. From 2007 to 2024, active discussions began regarding the fundamental flaws with the research—the characteristics of the study participants, the study design and the conclusions.
Questions were raised as to whether the study included participants of the right age, whether the higher than average BMI was the right starting point or if the approach of limited drugs with fixed dosing and delivery—and lack of inclusion of other delivery, drugs and dosing regimens—was appropriate. Pivotal to the new conversations were new reviews and analyses of the study, new positioning statements from leading industry organizations—all of which consistently contradicted the published 2002 results.
In 2012, the International Society for the Study of Women’s Sexual Health and The North American Menopause Society (NAMS, rebranded to The Menopause Society in 2023) determined that terms like vulvovaginal strophy, which described the impact on the vulvar and vaginal tissue of estrogen loss, did not adequately describe the clinical and scientific understanding of what HCPs were seeing and patients were experiencing.
Following a process of a formal conference, strategic discussions and review of options, ISSWSH and NAMS agreed to the more comprehensive term of Genitourinary Symptom of Menopause in 2014. GSM included genital, sexual and urinary symptoms, the first-line prescription treatment for which was hormone therapy. The black box warning had been discouraging women from using low-dose vaginal estrogen for treating GSM.
After years of effort, data review, expert panels, discussion, re-analysis, lobbying, advocacy and public comment, on November 10, 2025, the FDA announced that it was requesting that companies remove the black box language on all forms of hormone therapy. The ruling specifically recommended removing concerns related to cardiovascular disease, breast cancer and potential dementia. In addition, the FDA suggested adding new language to recommend HRT starting within 10 years of menopause, or before 60 for systemic HRT.
Following the announcement, 29 companies submitted proposed labelling changes. In February 2026, the FDA approved label changes for 6 menopausal hormone therapy products, and the progress continues.
So, what to make of this long and winding road? Will we see much wider usage of menopausal hormone therapy products? Will HCPs feel more comfortable them? Will we see a generation of women who don’t have to suffer unnecessarily? According to Anna Edney from Bloomberg, “Women are racing to get the once-vilified treatments, which help relieve hot flashes and other symptoms of menopause.”
The many of us working behind the scenes hope that this successful process will lay the foundation for future improvements in women’s health. Maybe our next round of changes will be short and direct - not long and winding.
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