An FDA hearing this week looked at hormonal treatments—finally.
Originally published in The Contrarian on July 16, 2025.
In “The Fight for Midlife and Menopausal Health Is Essential to Reproductive Rights—and Democracy,” my first piece published by The Contrarian (way back in January), I wrote, “It may sound surprising to hold out hope for the immediate future of any women’s health issue. But I think menopause may be an outlier.”
Five months later, CNN and NPR published back-to-back articles crediting a burgeoning movement for pushing state legislatures to take up issues such as insurance coverage of menopause treatments, improved education for doctors and more robust workplace protections.
Seven of the dozens of bills introduced are now law: California, Illinois, Louisiana, Maine, Rhode Island and Washington lead the nation when it comes to codifying menopause policy.
What happens in statehouses surely matters. I recently wrote for The Contrarian: “The tone set in the states can send a nationwide signal of just how far we can expect politicians to go in defending or degrading democracy.”
For sure, far too many extreme bills see the light of day thanks to gerrymandering, voter suppression and concentration of power. In the case of menopause, though, I dare say a rare combination of bipartisan commitment and robust public attention reflect not just heightened interest among constituents but also proof of the democratic process actually working. I am always glad to celebrate a win!
Even with all the menopause momentum, I somewhat expected the issue to stay out of the federal fray. Given its history at the margins of health research—a measly 1 percent of the National Institutes of Health’s annual spending in 2023 went to menopause (the first year it was tracked)—it would have hardly been surprising for this administration to ignore, even as it doubles down on attacks on abortion and reproductive care.
But hold onto your hats, menopause has arrived! On Thursday, July 17, the Food and Drug Administration held a two-hour briefing featuring FDA leadership and a panel of doctors to focus on menopausal hormone treatments. (The session was livestreamed; you can watch the recording here.)
The menopause medical and advocacy community believes that rectifying the labeling of vaginal estrogen is essential, lifesaving and long overdue.
Among the issues addressed was a decades-old labeling requirement for estrogen products—a.k.a. the “black box warning.” FDA commissioner Martin Makary appears willing to consider scrapping it on packaging for localized vaginal estrogen treatment.
The FDA should do so: The label is inaccurate and utterly alarming.
In her 2023 book Hot and Bothered, New York Times health and wellness columnist Jancee Dunn regaled her first foray with vaginal estrogen.
“When I brought the tube home from the pharmacy, I was alarmed by the all-caps warning emblazoned on the box, alerting users of the risks of ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER, AND PROBABLE DEMENTIA. (Probable dementia?).”
Dunn is hardly alone in her all-out, ALL-CAPS panic. It is all too common for women to read the label and promptly throw the prescription in the trash—or for doctors not fluent in menopause care (translation, the vast majority, including OB-GYNs) to refuse to prescribe it at all.
The labeling is rooted in a decades-old push-and-pull with the federal government.
When estrogen became all the rage in the 1970s, the FDA issued a mandate to provide stringent written warnings about benefits and risk on all usages, including the birth control pill.
In the 1990s, the FDA began to allow a more iterative labeling process for menopause.
But by 2003, after the disastrous Women’s Health Initiative announcement linked menopause hormone treatment to elevated risk of breast cancer, the FDA adopted the most stringent boxed labeling format.
Advocates, not industry or politicos, have taken the lead in fighting for accurate labeling, making the case that vaginal estrogen is not only the most effective treatment for genitourinary symptoms of menopause but also that addressing those symptoms improves and saves women’s lives.
New data makes the economic case. According to urologist and sexual health expert Dr. Rachel Rubin (who was among those presenting at the FDA yesterday), eliminating the warning would also save our healthcare system billions of dollars. “As women get older, they become more susceptible to frequent urinary tract infections,” she explains. “We have excellent data, spanning many decades, showing that vaginal estrogen products reduce the risk of future UTIs by more than 50 percent—which means less pain, fewer urgent care visits and hospitalizations, and even reduced risk of death, due to sepsis.”
Rubin is part of a team that published a 2024 report showing that if Medicare patients regularly received vaginal estrogen, the program could save billions per year.
In 2014, physicians filed a citizen petition to counter the FDA requirement, which the agency denied. Last year, the effort was resurrected by the nonprofit Let’s Talk Menopause (of which I serve on the board) through a national campaign called Unboxing Menopause.
It feels especially important that readers and the general public know this history, given the current state of crisis and chaos among U.S. federal health agencies, especially the FDA. I am writing to make clear the menopause medical and advocacy community believes that rectifying the labeling of vaginal estrogen is essential, lifesaving and long overdue … and is turning out—for the sake of women and democracy—to hold the FDA to a fair, transparent process at Thursday’s hearing and thereafter.
