The FDA…Did Good?

November 11, 2025

Like seriously? ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌

November 11, 2025

Greetings, Meteor readers,

It’s 11/11, make a wish.

In today’s newsletter, we’re feeling optimistic about menopause. Plus, a stunning upset in Kansas City.

🥶🥶🥶🌷,

The Meteor team

WHAT’S GOING ON

What’s the HRTea?: Yesterday, Martin Makary, the FDA commissioner, announced that hormone therapies for menopause will no longer be required to carry the black box warning they’ve borne for nearly two decades. It was a difficult moment to process, mainly because it’s almost impossible to believe that a government agency overseen by a man so opposed to science actually appears to be…following the science. And for the benefit of women!?

Let’s be clear: There were some fruit loops mixed in with the rational research presented by the FDA yesterday. In a breakdown of the event, reporters at Mother Jones highlighted some of the more dangerous claims, like the suggestion that untreated menopause symptoms lead to divorce (they do not) and that menopause kills women (also nope).

ACTRESS HALL BERRY, LAST YEAR, DURING A BIPARTISAN EFFORT TO INCREASE FEDERAL RESEARCH ON MENOPAUSE (VIA GETTY IMAGES)

Makary and Co,’s antics aside, though, “this announcement was a step in the right direction,” says Claire Gill, founder of the National Menopause Foundation. “Removing the black box warning from low-dose vaginal estrogen products is a positive step toward improving women’s midlife health and beyond. And it’s something leading menopause experts and advocates have been trying to get corrected on labeling for more than 20 years.”

If you’ve never seen one before, a black box warning (which is the highest form of warning the FDA can issue about prescription medication) lists the most severe risk factors in taking a drug. In addition to drugs used in hormone replacement therapies (HRT), the FDA has placed black box warnings on some antidepressants, opioids, and NSAIDs.

In the case of HRT, the FDA issued its warnings—citing risk factors like heart attack, stroke, and breast cancer—following an initial women’s health study that began in 1991. But ”the risk and/or effectiveness of HRT was not something originally in the scope of the study,” Gill explains. When researchers at the time observed the data, there was a slight increase in breast cancer among women in the study who were on HRT versus those who were not. “What we now know,” Gill says, referencing an updated report from JAMA, “is that the women in that study at that time had initiated hormone therapy more than 10 years after they reached menopause. When the data was reviewed to determine the risk for women who started on HRT closer to the onset of menopause, it was shown that there was actually no additional risk for any of those conditions and, in fact, there were some very positive benefits [to taking HRT], in breast cancer risk reduction and osteoporosis prevention, among other things.”

And as research since then has shown, HRT—while not a miracle drug, and not recommended for all women—can be an immense help in improving quality of life, reducing certain menopausal symptoms like vaginal dryness, pain during sex, and incontinence. And “an important next step,” Gill adds, “would be to convene medical societies whose members…treat women at midlife and beyond—gynecologists, internal medicine, family medicine, urologists, sexual medicine, geriatricians, etc.—and have a robust discussion to come to consensus on what all of them agree on when it comes to HRT and estrogen therapy. That would provide enormous benefit to advancing menopause care in the U.S.”

AND:

Politicians have paid a steep, steep price to secure a continuing resolution to reopen the government after a 42-day shutdown. The cost? Reproductive rights. Healthcare for low-income Americans. And food. So the question many of us are left with is, who really won this round?
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