Last week, the Department of Health and Human Services (HHS) announced game-changing news for women in perimenopause and menopause: Under the leadership of President Trump and First Lady Melania Trump, the FDA has approved three new black box labeling revisions for hormone replacement therapy products — all estrogen patches — and intends to update labels for all estrogen and progesterone therapy products by Christmas. Warnings of cardiovascular disease, breast cancer, and probable dementia have long deterred women and doctors from these treatments, even though the evidence no longer supported them. Now, for the first time in 20 years, women finally have access to the best products for them, and demand is surging. To keep up with the market, HHS has also announced plans to expedite manufacturing and approved a new generic estrogen patch intended to improve affordability and access.
These are exciting changes for women who want to make decisions based on scientific evidence — not fear or outdated assumptions. But they’re only the latest example of how Secretary Robert F. Kennedy Jr.’s HHS is transforming women’s healthcare through better research, more treatment options, and lower costs for care.
Two weeks ago, President Trump signed an Executive Order (EO) spearheaded by First Lady Melania Trump that announced an all-of-government effort to improve women’s health. The order establishes a Women’s Health Division at the National Institutes of Health that, for the first time in history, will provide scientific review of grants to fund research into conditions impacting millions of women and girls, such as endometriosis and pelvic floor disorders. Women deserve earlier diagnoses, treatments, and interventions founded on robust data and gold standard evidence, and this EO is an important step toward delivering for them.
The Order also created the White House Women’s Health Task Force, co-chaired by Secretary Kennedy and White House Chief of Staff Susie Wiles, to pursue a comprehensive approach to women’s health that recognizes evolving health needs from infancy, childhood, and adolescence through pregnancy, midlife, menopause, and aging.
Following the first White House Women’s Health Task Force meeting, HHS launched a joint effort to improve breast cancer detection and follow-up care for women in midlife and menopause. It will use patient data to track when women get screened, which tests they receive, how quickly they get follow-up care, and their health outcomes.
Through our Advanced Research Projects Agency for Health (ARPA-H), we’re also funding programs to build cancer biomarkers by harnessing advanced technologies and better understanding tumor biology. And thanks to a new collaboration with DenseBreast-info.org, we’re improving breast cancer screening, expanding breast density education, and encouraging timely diagnostic follow-up. On the heels of Breast Cancer Awareness Month, we’re reminded of our commitment to pursuing gold-standard evidence for the nearly 383,000 American women who will hear the words “You have breast cancer” this year.
But the wins for women don’t end there.
In addition to last week’s announcement, the FDA is expanding access to menopausal therapies by working with sponsors to explore the potential for over-the-counter availability of vaginal estrogen products. Women no longer have to accept urinary tract infections (UTIs) as an inevitable part of aging, because vaginal estrogen can help prevent recurrent UTIs. And healthcare professionals won’t need to prescribe antibiotics as often, because women who use vaginal estrogen will experience fewer UTIs. There is no age limit to vaginal estrogen.
HHS is also supporting fertility and reproductive care by launching the first national training center focused on infertility education and technical assistance and establishing new Reproductive Health Centers of Excellence. We’ve strengthened maternal and infant health, launched Moms.gov, expanded evidence-based home visiting, and advanced the HHS Perinatal Improvement Collaborative. And we’re investing in research on endometriosis, polyendocrine metabolic ovarian syndrome, infertility, autoimmune disease, hormone health, maternal health, midlife health, and other conditions that have received far less attention than they deserve. Thanks to TrumpRx.gov, many of these treatments are now more affordable with transparent Most Favored Nation pricing — and more will be added soon.
HHS is revolutionizing women’s health, and the results are tangible. I attended the FDA’s recent workshop on Testosterone Use in Menopausal Women, where one woman shared how she spent years suffering from menopause-related symptoms that went unrecognized as related to one another. It was a difficult journey that delayed her access to menopausal hormone therapy when she needed it most. When she found a doctor who tied all of her symptoms together and helped her know her hormone therapy options, it changed her life and made her feel herself again. Stories like hers are a powerful reminder that no woman should have to endure confusion and distress to get the treatment she deserves. By removing outdated black box warnings on hormone therapy, the FDA is empowering women to receive the timely, evidence-based care they deserve.
The days of treating conditions in isolation are over. Our mandate today is clear: Prevent chronic disease, identify root causes, expand access to high-quality care, and make sure scientific discoveries do, in fact, improve the lives of women. When we invest in a woman's health, we invest in her family, her community, and the health and strength of our nation. It moves us one step closer to achieving President Trump’s directive to Make America Healthy Again.
Dr. Dorothy Fink, Deputy Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development
