Far too many extreme bills see the light of day thanks to gerrymandering, voter suppression and concentration of power. In the case of menopause, 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.

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?).”

According to urologist and sexual health expert Dr. Rachel Rubin (who was among those presenting at the FDA July 2025), 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" 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.