FDA’s Menopause Policy Shift: What It Means for Sponsors and Innovators

The U.S. Department of Health and Human Services (HHS) advance Menopausal Health by removing misleading FDA warnings on hormone replacement (HRT) and approving two new drugs to expand treatment options for menopausal symptoms (Ref 1,2,3, 4). These regulatory changes signal a significant opportunity for healthcare innovators, biopharma companies, and service providers.

Key FDA Actions

HRT Label changes:

The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature, an advisory panel in July 2025, and a public comment period ^(1,2,3,4). The FDA’s hormone therapy updates include: 

• Removal of boxed warnings for cardiovascular disease, stroke, breast cancer, probably dementia, except for the boxed warning in systemic estrogen labels for endometrial cancer with unopposed estrogen in women with a uterus.
• Removal of the recommendation to prescribe hormone therapy at the lowest effective dose for the shortest duration.
• Tailored safety information where instead of applying identical class-based language across all hormone therapy labels, safety data will be revised to reflect risks most relevant to each specific type of hormone therapy product.
• For the topical vaginal estrogen-only drug label, the emphasis is on the safety findings most relevant to topical vaginal use.
• Timing information for systemic hormone therapy: Labels will include updated guidance on initiating treatment in women younger than 60 years or within 10 years of menopause onset to optimize the benefit-risk balance.

The American College of Obstetricians and Gynecologist (ACOG) came out in support of this decision commending the HHS leadership for improving the lives of perimenopausal women by making the estrogen products they need more accessible to them ⁽⁵⁾.  The labeling revisions can be interpreted as a meaningful shift toward more nuanced, evidence-based communication of hormone therapy risks.

New Approvals Expand Market Potential

The FDA has recently approved two new menopausal treatment options ^(6,7). 

• Generic Premarin (conjugated estrogens): The first such approval in more than 30 years for this widely used hormone replacement therapy (). The new generic product is expected to improve affordability and access while maintaining the same quality, safety, and effectiveness as the brand-name drug.
• Non-hormonal treatment for moderate to severe vasomotor symptoms (such as hot flashes): This option provides relief for women who cannot or choose not to use hormone therapy.

What is next? 

Women experiencing menopause are the fastest growing demographic in today’s workplace; an estimated 1 billion women worldwide will be experiencing menopause or are postmenopausal by 2030.  There is significant potential for innovators to play a major role in this fast-developing market ⁽⁸⁾.

The FDA labelling updates of HRT and the recent approvals of two drugs for treating menopausal symptoms, reflect the FDAs strong commitment to advance Women’s Health and  indicates potential opportunities for innovators in this space. These regulatory updates create significant opportunities for sponsors across multiple fronts. 

Rapid adaptation to new labeling requirements will drive demand for regulatory consulting. Evolving guidance on dosing and timing opens the door for clinical development programs focused on enriched populations. Meanwhile, affordability and real-world outcomes will make market access and HEOR strategies critical differentiators. Finally, patient recruitment efforts must target perimenopausal and early postmenopausal cohorts to optimize trial success.

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