Inaccurate labeling and classification of menopausal hormone treatments have thwarted women’s
access to quality health care for more than two decades. The good news? We are in the midst of major reform momentum.
On Monday, Nov. 10, the U.S. Department of Health and Human Services announced that the Food and Drug Administration would eliminate the “boxed labeling” requirement for estrogen products.
The “black box warning,” as it’s commonly called, is part of the fallout from a press conference that occurred more than 20 years ago, announcing the findings of the Women’s Health Initiative (WHI). It’s also been the subject of a half-century-long push and pull with the federal government.
The backstory
When estrogen became all the rage in the 1970s, the FDA issued a mandate to provide stringent written warnings about its benefits and risks. At the time, this move was widely celebrated as a feminist win and a way to ensure women were armed with information to make decisions for themselves without medical gatekeeping.
By the 1990s, the FDA initiated a more iterative labeling process for menopause treatments in order to keep up with new observational research. All that changed following the WHI’s misread of its data and the public frenzy it stoked.
As a result, the FDA revisited the warning on estrogen, and in 2003 the agency upgraded the requirement to the most stringent “boxed labeling” format, which is applied to products that cause serious life-or-death reactions. In this case, the label warned of numerous conditions, including breast cancer, heart disease, blood clots, and probable dementia. Apart from an increased risk in blood clots, none of the other warnings were statistically significant. (In medical research parlance, a non-statistically significant finding is not a finding.)
Not surprisingly, the warning language and prominent placement caused undue alarm among patients and doctors alike. Usage plummeted — and a generation of women suffered.
Fast forward to today
With menopause advocacy gaining global attention, a modern campaign for better policies has emerged. Over the past year, the online citizen’s petition organized by Let’s Talk Menopause in support of removing the boxed warning from vaginal estrogen garnered more than 26,000 signatures. Nineteen states have introduced more than three dozen bills to improve menopause education and care.
And the FDA, too, has now stepped up. In July, it convened a first-ever publicly broadcast roundtable discussion on menopausal hormone treatments; a dozen physicians presented, urging regulators to finally align policy with the data. The panel was followed by an open public comments and feedback period over several weeks.
At Monday’s press conference and in a corresponding piece in JAMA, FDA commissioner Dr. Marty Makary shared that this process led the agency’s internal experts to determine that removing the boxed labeling requirement was the right thing to do. Make no mistake, this has been a longstanding demand — it’s neither new nor MAHA-driven. Doctors and scientists have made the case for its removal since the start to no avail, arguing the data from the WHI — the largest, most expensive, and only randomized placebo-controlled study of post-menopausal women — never supported putting it there in the first place.
This is surely the case for local vaginal estrogen. Experts across the board agree that it is safe to use, that it is the most effective treatment for vaginal dryness and urinary tract infections, and that addressing those symptoms improves women’s long-term health, quality of life, and longevity. Local vaginal estrogen is deemed so safe, in fact, that other countries including the U.K. have made it available over the counter.
What comes next?
A regulatory course correction is big — but it’s only half the battle. After two decades of fear and misinformation, the challenge ahead entails helping the public and clinicians understand what the labeling status change does (and doesn’t) mean.
To do this, we first must ensure that doctors themselves are educated about menopause; hormone therapy may not be for everyone, but everyone deserves a conversation about it as they enter the menopausal transition.
Also, patients should know that removal of the black box does not equate to no warnings. All medications have side effects and risks, and hormone therapy is no exception. The FDA’s next step will be to provide appropriate revised language for vaginal and systemic menopause hormone treatments. For the latter, it’s especially important that the benefits and risks be individually assessed and based on personal medical history.
A particularly thorny issue right now, of course, is managing the public response in the midst of a crisis in support for federal agencies. The New York Times reported, “Americans have always been ambivalent about public health in general and the American regulatory project in particular. We want protection from bad food and bad medicine and other unsafe products, but we also want to draw the line between safe and unsafe for ourselves and to redraw it whenever we see fit. The FDA has always reflected this tension.”
For the here and now? Our advice is to trust the physicians, the researchers, and the scientists who have advocated for this for decades regardless of who happened to be in charge of the FDA.
This includes the Menopause Society and ACOG, among others.
And importantly, don’t let polarization muddle the message. This is about policy, not politics. Our job is to continue to discuss hormone therapy the same way we would any medication. At long last, we are free to have this conversation without the unnecessary fear factor that the black box warning engendered.
Make no mistake: The FDA’s reversal of the labeling requirement is a major win for evidence-based medicine. Now it’s up to us to responsibly inform women of their choices.
Dr. Sharon Malone is a DC-based OB/GYN and Certified Menopause Practitioner, as well as the author of Grown Woman Talk.
Attorney and author Jennifer Weiss-Wolf is executive director of Birnbaum Women’s Leadership Center at NYU Law.
