BY Luke Zarzecki , November 10, 2025
FDA will continue to be advised by “expert panels” instead of advisory committees in some cases, FDA Commissioner Marty Makary said as he touted the review method at an HHS event Monday (Nov. 10) announcing the removal of black box warnings from hormone replacement therapy products for menopause. Health research experts told Inside Health Policy the “expert panel” that advised Makary on the decision had conflicts since almost all of its members would benefit financially from the black box warning being eliminated.
Makary said advisory committees governed by the Federal Advisory Committee Act, FDA’s longtime method for consulting outside experts, are bureaucratic, long, often conflicted and very expensive. He added the agency can have spontaneous and more robust discussions with medical experts on the less-formal panels.
“We’re doing both advisory committees following the long, FACA process in the government and we are also convening experts to say ‘speak your mind passionately, state your conflict of interest if you have any, speak your mind passionately about an important topic in medicine that is not being talked about and needs to be talked about ’ and this was one of those panels,” Makary said. “We also had a similar forum on SSRIs in pregnancy, we had one on cell and gene therapies, so we are going to continue to have those it allows us to have a robust debate without all the bureaucratic barriers.”
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The idea has sparked criticism. Inviting experts to temporarily testify on ad-hoc informal panels, rather than convening formal federal advisory committees with a charter and set membership, evades FACA disclosure requirements, critics say. Unlike advisory committee meetings, the expert panels do not require publication of a notice in the Federal Register, the keeping of minutes or a transcript, or disclosures from members about conflicts of interest.
HRT warnings
FDA said in a statement Monday it is removing the HRT warnings after a “comprehensive review of the scientific literature, an expert panel in July, and a public comment period.” The change removes references to risks of cardiovascular disease, breast cancer and probable dementia. The agency is not removing the boxed warnings for endometrial cancer for systemic estrogen-alone products.
“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” HHS Secretary Robert F. Kennedy Jr. said. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”
Conflicts of interest
Diana Zuckerman, president of the National Center for Health Research, told Inside Health Policy in a statement the members of the “expert panel” had conflicts of interest because “virtually all its members would benefit financially from the black box warning being eliminated”
“That’s because they would have more patients seeking their services, and that is a financial conflict of interest as well as a conflict caused by their becoming better known in their field,” she said.
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Adriane Fugh-Berman, a Georgetown professor of pharmacology and physiology, told IHP Makary sought out experts who agreed with him on the topic.
“His handpicked ‘expert’ panels are put together to rubberstamp his preexisting views — they are rife with people with conflicts of interests, include unqualified people, lack any public comment section, and are full of people spouting their often uninformed opinions rather than assessing data,” she alleged.
HHS did not respond to IHP prior to publication on the alleged financial conflicts of interest.
Zuckerman said Makary thinks the only conflict of interests of importance are from pharmaceutical company funding. While the advisory committee system isn’t perfect, she said, FDA’s new format isn’t an improvement.
“In some cases it seems that the FDA designs advisory committee meetings to come to a specific conclusion, and they do that by ‘stacking the deck’ of the committee members as well as the FDA staff presentations,” she said. “Even so, FDA advisory committee meetings are usually much more scientific and nuanced than the recent ‘expert panels’ — a term that should always be in quotation marks because they are very one-sided and some of the ‘experts’ do not seem at all expert.”
Menopause treatment controversy
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The dispute over hormone therapy for menopause stems from a National Institutes of Health-backed trial of menopausal hormone therapy and its impact on risks of heart disease and other chronic conditions, part of the Women’s Health Initiative, which was halted in 2002 because of patient safety concerns. Researchers said the trial was showing an elevated risk of breast cancer, blood clots and stroke that outweighed the benefits.
Panelists at the FDA event in July said the findings of the Women’s Health Initiative (WHI) study were misinterpreted and the risks of hormone therapy for menopausal women have been overstated, while its benefits have been downplayed. The trial also focused on oral combination drugs, while other options for administration are available now.
Kennedy said Monday hormone replacement therapy reduces the risk of cardiovascular disease and mortality, Alzheimer’s disease, cognitive decline, bone fractures and all-cause mortality. He said the WHI study was not statistically significant.
“It triggered a media frenzy and led to the FDA applying unscientific black box warnings to all hormone replacement therapy products in 2003. The label was designed to frighten women and silence doctors,” he said.
But women’s health professionals urged FDA in August to avoid making changes to its boxed warnings on estrogen hormone therapy products without consulting an independent advisory committee, complaining the July panel included only supporters of hormone therapy.
Fugh-Berman said the WHI study demonstrated hormones do not prevent cardiovascular disease and increased the risk of dementia. She said that the risk of invasive breast cancer was significantly increased for patients who used HRT, and it increased progressively over time.
“Hormones also increase the risk of stroke, pulmonary embolism, gallbladder disease, ovarian cancer, and other conditions,” she said. “Makary’s statements that the breast cancer risk was not significant is entirely wrong.”
Zuckerman said it would be reasonable to revise the black box warning, but not to eliminate it, since some of the hormone products for menopause have scientific evidence that they cause uterine cancer and stroke for some patients, and breast cancer is also a risk for some women.
“In any other product, that would warrant a black box warning. That’s why removing the black box warnings from all hormone products for menopause is a step backwards, despite the FDA commissioner’s statement that these drugs would greatly benefit millions of women,” she said.
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Zuckerman says topical creams have been shown to be safe in the short term, though long-term data is “skimpy.” Systemic hormones have clear risks and some clear benefits, she said.
“The warnings on hormone products for menopause had become outdated and it was time to update them. However, these products still have clear risks and the benefits are mostly for hot flashes and related symptoms of menopause, not for general health,” she said. “Hormones are not the ‘fountain of health’ that Dr. Makary claimed. They absolutely are not proven to prevent dementia and the frequently touted benefit for osteoporosis only lasts while the woman is taking the hormones, not after she stops.”
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