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PharmedOut statement on menopausal hormone therapy label change

November 11, 2025

FDA’s Hormone Decision Rewrites Science and Misleads the Public
PharmedOut director warns new FDA leadership is echoing the glowing language once crafted by pharmaceutical marketers

WASHINGTON, D.C., November 11, 2025 — The FDA’s decision to remove the black-box warning from menopausal hormone therapy (MHT) is being called a dangerous distortion of science by experts who say the agency is now echoing the glowing language once crafted by pharmaceutical marketers.

“The science hasn’t changed—just the people in charge,” said Adriane Fugh-Berman, MD, director of PharmedOut, an initiative at Georgetown University Medical Center that studies how pharmaceutical marketing influences medicine. “The Women’s Health Initiative remains the largest and most rigorous study on hormone therapy, and it found clear increases in breast cancer, stroke, blood clots, gallbladder disease, and dementia in older women. Those risks are still there. Pretending harms don’t exist doesn’t make them disappear.”

The announcement was led by FDA Commissioner Marty Makary, MD and Alicia Jackson, a new Health and Human Services appointee who previously co-founded Evernow, a telehealth company providing virtual menopause care and prescribing hormone therapy online. Evernow raised $28.5 million in 2022 with the help of venture capital firms, securing celebrity investments from Gwyneth Paltrow and Cameron Diaz, before Jackson joined HHS.

The FDA did not convene an advisory committee to evaluate data. Instead, Makary convened an unconventional group of hormone promoters, many with conflicts of interest, all of whom advised lifting the black-box warning for vaginal estrogen, used locally for dryness and discomfort. On November 10th, the FDA announced label changes to systemic hormone therapy—formulations linked to serious harm in the Women’s Health Initiative (WHI).

The WHI, which followed more than 27,000 postmenopausal women, found that combined estrogen-progestin therapy increased the risk of invasive breast cancer, stroke, pulmonary embolism, gallbladder disease, and probable dementia among women over 65. Estrogen-only therapy increased the risk of stroke, ovarian cancer, and deaths from ovarian cancer. Neither regimen reduced the overall risk of heart disease or improved survival. While some benefits were seen—including reductions in hip fractures and a modest reduction in diabetes—the harms far outweighed any gains.

“These findings led to the black-box warning in the first place,” said Fugh-Berman. “Hormone therapy can relieve hot flashes and vaginal dryness, but it should never be sold as a path to disease prevention or longevity. That’s what the science shows.”

In a press conference on Monday, Secretary Kennedy praised the FDA’s move as a recommitment to evidence-based medicine, claiming that hormone therapy reduces risks of heart disease, Alzheimer’s, fractures, and mortality by up to 50 percent. Makary went even further: “HRT has saved marriages, rescued women from depression, prevented children from going without a mother,” he said.

Those claims are unfounded and contradict findings from multiple randomized controlled trials of hormones. Critics say the FDA’s tone sounds more like promotion than regulation. “It’s highly unusual for the agency to glowingly endorse a therapy,” said Fugh-Berman. “The FDA’s role is to inform the public about risks and benefits—not to reassure women that a controversial drug is safe.”

PharmedOut and other public-health advocates warn that the move reflects a broader trend in U.S. healthcare: public-interest oversight is fading while corporate and influencer messaging grows louder. “The black-box removal gives the false impression that the risks have disappeared,” Fugh-Berman said. “They haven’t—and women deserve accurate information, not hype.”

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