After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
The FDA will remove the black box warning on all hormone replacement therapies, reversing a 22-year-old decision Health Secretary Robert F. Kennedy Jr. characterized in a press conference Monday morning as the American medical establishment “turn[ing] its back on women.”
“Millions of women were told to fear the very therapy that could have given them strength, peace and dignity through one of life’s most difficult transitions, menopause,” Kennedy said, standing alongside FDA Commissioner Marty Makary, Second Lady Usha Vance and other government representatives and physicians. “That ends today.”
The black box warning—the strongest the FDA can levy on a product—for hormone replacement therapies (HRT) stemmed from a 2002 landmark study called the Women’s Health Initiative (WHI) that found an increased risk of heart disease and breast cancer associated with the class of drugs. In a statement Monday, the Department of Health and Human Services noted that this increase was “statistically non-significant” and pointed out that the average age of its participants was 63 years, “over a decade past the average age of a woman experiencing menopause,” according to the agency.
The global HRT market was estimated to be nearly $24 billion in 2024 and is projected to reach nearly $40 billion by 2033, with North America accounting for the largest share and Asia Pacific the fastest growing market, according to Grand View Research. Leading pharma players are Bayer, Pfizer, Ascendis Pharma and Novartis Gene Therapies.
The FDA’s decision follows the convening of an expert panel on menopause and hormone replacement therapy in July. This represents a new format for the agency during which an “independent panel of scientific experts” will “review the latest scientific evidence, evaluate potential health risks, explore safer alternatives” and possibly offer recommendations for regulatory action.
The panel faced criticism over apparent bias, with Diana Zuckerman, president of the nonprofit National Center for Health Research, telling BioSpace in September that she was struck by the lack of nuance presented during the session, as well as a later panel focused on SSRI use during pregnancy.
During Monday’s press conference, Kennedy listed a number of statistics, including that HRT has been found to reduce the risk of cardiovascular disease and mortality by as much as 50%, Alzheimer’s disease by 35% and bone fractures by 50–60%. Kennedy claimed these factors combined could “extend [women’s] lives by as much as 10 years.”
Makary, who called Monday a “historic day for women in the United States,” added that women who took estrogen alone in fact had a 24% reduction in breast cancer. A breast cancer research page attributing this stat to the WHI notes a 23% reduction in breast cancer diagnoses and adds that women taking estrogen-only HRT are 44% less likely to die from the disease.
Prior to 2002, one in four American women used hormone replacement therapy, Kennedy claimed. Today, he said, that number is fewer than one in 20. “That’s not progress, that’s neglect, that’s malpractice. We can no longer accept a culture of fear that blocks innovation and keeps patients from proven therapies.”
In related news, the FDA recently signed off on Bayer’s oral therapy Lynkuet for moderate to severe hot flashes in menopausal women. Lynkuet is the first FDA-approved therapy that blocks both the neurokinin 1 and neurokinin 3 receptors to treat this common symptom of menopause.
