LAUREN GARDNER and DAVID LIM, Politico, October 28, 2025
OUT OF THE BLACK BOX? The FDA could announce as soon as this week a change to the black box warning on estrogen products used to treat menopause symptoms — a policy move that would be the first to stem from Commissioner Marty Makary’s “expert panel” series.
Makary told CNN’s Sanjay Gupta on a podcast earlier this month that the FDA was having “serious discussions” about the warning with changes coming “very soon.” He focused a chapter of his 2024 book “Blind Spots” on an NIH-backed hormone therapy clinical trial that was halted in 2002 amid concerns about cancer and stroke risks, blasting the study’s administrators for misinterpreting the data.
It’s unclear how far the agency will go, according to advocates monitoring the issue. Some of the speakers at Makary’s July panel discussion are medical advisers to a group petitioning the FDA to remove the boxed warning from vaginal estrogen products, arguing that it deters providers and patients from using them.
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At issue: The FDA could opt to remove the warning for topical, nonsystemic estrogen creams or ointments that treat dryness and other genitourinary symptoms that some women experience while going through menopause.
Existing evidence suggests those localized low doses are safe, though Diana Zuckerman, president of the National Center for Health Research, said there’s a dearth of data from long-term controlled trials. Any changes to the black box warning should distinguish between local and systemic therapies, the latter of which she said pose some risks depending on the timing and duration of treatment and the patient’s health profile.
“There’s a lot of nuance in the research,” said Zuckerman, who criticized the July panel as being skewed in favor of hormone therapy. “But when it is presented as if there is no risk here of cancer or heart disease or anything else, that is just completely untrue.”
The opportunity: But Anne Fulenwider, co-founder and co-CEO of telehealth platform Alloy, said removing the warning will help “millions and millions of women” gain greater access to those therapies.
“Even if it is [removed from] just one of them, that is a huge step for all women,” Fulenwider said. “Everyone is afraid of estrogen to their detriment.”
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