Reconstructing Menopausal Hormone Therapy Guidelines: From Palliative Symptom Management to Age-Related Endocrine Insufficiency Disease Prevention

On November 10, 2025, the FDA formally reversed twenty-three years of restrictive guidance on menopausal hormone therapy (MHT), acknowledging that the Women's Health Initiative evidence does not appropriately apply to modern formulations. This regulatory reversal exposes a persistent institutional inertia: despite acknowledgment, no guideline review or reassessment has been announced by ACOG or NAMS. More broadly, legal doctrine is shifting to prioritize evidence-based over consensus-based practice; MHT evidence has matured across 15-20 years of registry data; and international guideline divergence reveals that current U.S. guideline restrictions do not reflect global evidence interpretation. Professional organizations maintaining current guidelines now do so with explicit knowledge of these contradictions.Comprehensive guideline reconstruction is therefore not optional refinement—it is institutional necessity. Such reconstruction must address three interconnected dimensions: menopause reclassification from genitourinary/reproductive to endocrine disease—specifically, age-related endocrine insufficiency; clinical practice evolution toward formulation-specific evidence and precision medicine; and standards aligned with contemporary legal-ethical requirements. This article aims to integrate clinical evidence, institutional bias analysis, and legal/regulatory change into a coherent, actionable proposal for rebuilding menopausal hormone therapy guidelines.NOTE: The ICD-11 classification table in this article uses legacy ‘E‑series’ endocrine codes to illustrate menopause as an endocrine insufficiency alongside other hormone-deficiency states. In the current ICD‑11 architecture, these conditions are reorganized under the newer ‘5A/GA’ taxonomy, and the older E‑codes have been retired. The table is intended to depict menopause as an endocrine endocrine-insufficiency analogue, but is not fully aligned with the formal, contemporary ICD‑11 code structure, which has not yet been widely adopted or clinically familiar in the U.S.