WASHINGTON, D.C. — The long-standing FDA warnings on hormone replacement therapy for menopause are being dismantled, as the U.S. Department of Health and Human Services on Monday announced the removal of broad “black box” labels the FDA applied more than 20 years ago — a move federal officials described as a historic course correction for women’s health.
Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary said the agency is rescinding the sweeping warnings after an extensive scientific review, an expert advisory panel, and public comments revealed the labels overstated risks and discouraged women from receiving effective treatment.
The action follows two decades of controversy stemming from the early-2000s Women’s Health Initiative, which reported a small, statistically non-significant increase in breast cancer diagnosis among older women receiving a hormone formulation no longer widely used. The average age in that study was 63 — far older than the typical menopausal patient.
“For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT,” Kennedy said. “We are returning to evidence-based medicine and giving women control over their health again.”
Makary echoed that view, calling the previous warnings “a distortion of risk” that cost millions of women access to treatment that could have improved long-term health outcomes.
Under the FDA’s new direction, product labeling will be revised to remove longstanding claims about cardiovascular disease, breast cancer, and dementia risk. The black box warning for endometrial cancer will remain for estrogen-only products.
Federal health officials said the overhaul reflects a modern scientific consensus that hormone therapy, when started within 10 years of menopause or before age 60, can reduce all-cause mortality, lower cardiovascular risk by as much as 50 percent, and cut Alzheimer’s risk by 35 percent. Studies show fracture risk reductions of up to 60 percent.
Alicia Jackson, director of the Advanced Research Projects Agency for Health, called estrogen “a key hormone for women’s health,” adding that the policy shift “is an incredible step forward to empower millions of women to live longer, healthier lives.”
As part of the initiative, the FDA also approved the first generic version of Premarin in more than 30 years, a move expected to expand access and lower costs. Additionally, the agency approved a new non-hormonal therapy for moderate to severe hot flashes, offering more options for women unable or unwilling to take estrogen.
Longtime FDA Innovator to Lead Drug Evaluation Division
In a separate announcement on Tuesday, HHS named Dr. Richard Pazdur the new director of the FDA’s Center for Drug Evaluation and Research. Pazdur, a 26-year veteran of the agency and founding director of the Oncology Center of Excellence, is known for modernizing cancer drug reviews and launching global regulatory partnerships such as Project Orbis.
FDA Commissioner Makary called him “a true regulatory innovator who will help guide our broader agenda to modernize the agency and streamline the approval process.”
Pazdur said he is “honored” to lead CDER during a period of major regulatory reform.
FDA Adds New Safety Warning to Gene Therapy After Fatalities
On Friday, the FDA announced a major safety revision for the Duchenne muscular dystrophy gene therapy Elevidys following two fatal cases of acute liver failure in non-ambulatory patients.
The agency approved a new boxed warning — its strongest safety alert — and sharply restricted the treatment’s indication to ambulatory patients aged 4 and older. The manufacturer had already paused distribution for non-ambulatory patients after two deaths earlier this year.
The revised labeling adds extensive monitoring requirements, weekly liver function and cardiac testing, and cautions for patients with infections, recent vaccinations, or underlying liver disease. Elevidys is now contraindicated for patients with specific DMD gene deletions.
The FDA is also requiring a 200-patient postmarketing study to further evaluate liver injury risks.
Health providers and families are urged to report adverse events through FDA’s MedWatch system.
As gene therapies become more widely available, the agency said it will continue “rigorous oversight” to ensure safety and transparency while new data emerge.
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