Meeting | Mixed
Event Title
FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women
July 17, 2025
- Date:
- July 17, 2025
- Time:
- 1:00 p.m. - 3:00 p.m. ET
Roberta Diaz Brinton, PhD
Director, Center for Innovation in Brain Science
Regents Professor, Departments of Pharmacology and Neurology
College of Medicine – Tucson, University of Arizona
Kelly Casperson, MD
Board Certified Urologist
Expert and Advocate for Sexuality and Hormones
Heather Hirsch, MD, MS, NCMP
Board-Certified Internist
Founder and CEO, Health by Heather Hirsch MD Collaborative
Howard N. Hodis, MD
Harry J. Bauer and Dorothy Bauer Rawlins Professor of Cardiology
Professor of Medicine and Population and Public Health Sciences
Professor of Molecular Pharmacology and Toxicology
Director, Atherosclerosis Research Unit
Division of Cardiovascular Medicine
Keck School of Medicine
University of Southern California
Barbara Levy, MD, FACOG, FACS, MSCP
Clinical Professor, Obstetrics and Gynecology
The George Washington University School of Medicine and Health Sciences
Voluntary Clinical Professor, Department of Obstetrics, Gynecology & Reproductive Sciences
University of California, San Diego Health Sciences
Chief Medical Officer, Visana Health
JoAnn E. Manson, MD, DrPH, MACP
Chief, Division of Preventive Medicine
Brigham and Women's Hospital
Professor of Medicine and the
Michael and Lee Bell Professor of Women's Health
Harvard Medical School
Mary Jane Minkin, MD
Clinical Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences
Yale University School of Medicine
JoAnn V. Pinkerton, MD, MSCP, FACOG
Professor of Obstetrics and Gynecology
Division Director Midlife Health
The University of Virginia Health System
Past President and Emeritus Executive Director, The Menopause Society
Chair 2017 NAMS PS on Hormone Therapy
Rachel S. Rubin, MD
Urologist and Sexual Medicine Specialist
Assistant clinical professor in Urology at Georgetown University Hospital
Philip Sarrel, MD
Professor Emeritus of Obstetrics, Gynecology, and Reproductive Sciences and Psychiatry
Yale School of Medicine
James A. Simon, MD, CCD, NCMP, IF
Clinical Professor
George Washington University
Founder and Medical Director, IntimMedicine Specialists
Vonda Wright MD, MS
Orthopaedic Surgeon
Associate Professor of Orthopaedic Surgery
University of Central Florida
Founder & CEO- Precision Longevity
Webcast Recording: FDA Expert Panel on Menopause and Hormone Replacement - YouTube.
Media Inquiries: HHS Press Office
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.
In follow-up to this meeting that had 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.