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# Input Sought on Controversial Menopause Expert Panel
- URL: https://www.fdaweb.com/input-sought-on-controversial-menopause-expert-panel/
- Published: 2025-07-28T12:00:00.000Z
- Updated: 2026-09-14T15:17:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159580

Under mounting criticism of FDA commissioner **Marty Makary** bypassing the agency’s advisory committee processes to address health issues under an “expert panel” process, the agency 7/28 announced an open docket to collect public input on a 7/17 panel that addressed warnings associated with hormone replacement therapies (HRT) for menopause. The Makary-led panel is reviewing whether HRT risks have been overstated, potentially deterring women who could benefit from the treatment.

Georgetown University Medical Center’s PharmedOut director **Adriane Fugh-Berman** told [*MedPage Today* ](https://www.medpagetoday.com/washington-watch/fdageneral/116662?ref=fdaweb.com)that she suspects the expert panels “may be a run around advisory committees,” which are usually vetted, occupationally diverse, academically credentialed researchers who address a particular question. Fugh-Berman said most of the panelists at the menopause meeting, which she attended as an audience member, would not have met the criteria to serve on an advisory committee. “There was no process for selection; they seem all to have been chosen by Makary,” she said. “It was a parody.”

**Steven Grossman**, an FDA regulatory and policy consultant, also weighed in on the menopause expert panel. He noted that the panel quickly elevated an important topic, although it completely veered from the advisory committee system, which while not perfect, “has served FDA very well for many years.” However, convening the expert panel broke many norms, and “poor adherence to process renders any conclusion highly suspect,” he says.

An *Inside Medicine* Substack [post](https://insidemedicine.substack.com/p/exclusive-in-conversation-with-fda) by **Jeremy Faust** said the panels seem to be “hastily thrown together PR events. That said, their influence on any genuine regulatory activity, if any, remains opaque.”

In today’s [notice](https://content.govdelivery.com/accounts/USFDA/bulletins/3eb6f75?ref=fdaweb.com), FDA says that as a follow-up to the menopause meeting comments are now being accepted until 9/24 about 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,” it says. “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.”