Docket Open for Public Comments on the Risks and Benefits Related to Menopause Hormone Therapy
On July 17, 2025, the FDA hosted the FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women. The panel focused on the risks and benefits of menopause hormone therapy, and in particular, the risks of breast cancer, uterine cancer, and certain cardiovascular risks versus potential benefits on bone, genitourinary, cardiovascular, and cognitive health. Discussions focused on data regarding differential risks and benefits depending upon the age of hormone initiation, formulation, and dose since the original publication of the Women’s Health Initiative (WHI) Study.
As a follow-up to this meeting that included invited expert panelists who spoke in a public forum, the FDA is opening a docket to allow for submission of broad, public comments on the risks and benefits related to menopause hormone therapy, including data that could support updates to the labeling of such products. The agency is specifically interested in perspectives on risks and benefits concerning breast cancer, cardiovascular disease, genitourinary systems, bone health, and dementia. As well as being interested in how such risks and benefits might differ based on timing of hormone initiation, including age, duration of use, type of estrogen and progestogen used and dosage forms, including route of administration. This request is part of the FDA’s effort to understand various perspectives on these safety considerations and the use of hormone therapy for menopause-related conditions in clinical practice.
To be assured of consideration, comments must be received no later than 11:59 p.m. Eastern Time (ET) on September 24, 2025, at Regulations.gov in docket number FDA-2025-N-2589. The FDA will not reply individually to responders but will consider all comments submitted by the deadline.
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