Dr. Marty Makary is shaking up the FDA’s stance on menopause treatment, and the controversial debate could change everything you thought you knew about hormone therapy.

At a Glance

• FDA Commissioner Dr. Marty Makary is challenging long-held beliefs about menopause hormone therapy (MHT).
• Critics fear his approach may sideline established medical guidelines.
• The FDA panel is set to reassess menopause treatment risks on July 17, 2025.
• The outcome could alter perceptions and practices in women’s health care.

The Historical Context of Menopause Hormone Therapy

Menopause hormone therapy, once hailed as a panacea for hormonal havoc, became the medical equivalent of a haunted house after the early 2000s Women’s Health Initiative (WHI) study. The study’s findings linked hormone therapy to increased risks of breast cancer, heart disease, and stroke, causing its popularity to nosedive faster than a lead balloon. Fast-forward to today, and new research suggests the benefits may outweigh the risks for many women, particularly those under 60 or within ten years of menopause onset. However, the specter of the WHI study continues to spook both patients and providers.

Watch: FDA panel reassesses menopause treatment risks

The FDA’s cautious approach to menopause therapies has been shaped by the WHI fallout, with Dr. Marty Makary now poised to potentially rewrite this narrative. Appointed as the 27th Commissioner of the FDA in 2025, Makary is known for his contrarian views and willingness to challenge medical orthodoxy. His convening of a high-profile FDA panel on hormone therapy could signal a seismic shift in regulatory and public health messaging around menopause treatments.

Stakeholders in the Hormone Therapy Debate

Dr. Marty Makary stands at the center of this brewing storm, acting as both a disruptor and a reformer. He argues that the risks of menopause treatments have been overstated, leading to unnecessary suffering for countless women. The FDA, as the regulatory authority, seeks to balance public safety with access to effective therapies, while menopause societies and medical experts advocate for evidence-based care. Women’s health advocacy groups focus on empowering patients and improving access to treatments, while pharmaceutical companies eye regulatory clarity and market expansion.

Power dynamics are at play as Makary’s stance puts him at odds with some established medical authorities and guidelines. The FDA’s decisions will directly impact clinical practice, insurance coverage, and public perception, with medical societies and advocacy groups influencing public debate and provider education.

Current Developments and Future Implications

Dr. Makary’s actions have sparked a renewed debate over menopause therapy safety and access. He has publicly criticized outdated terminology and the exclusion of recent guidelines from FDA discussions, positioning himself as a reformer challenging entrenched medical dogma. The FDA panel, scheduled to meet on July 17, 2025, will review scientific evidence and regulatory frameworks for menopause therapies, with active debate within the medical community about the implications for patient care.

Short-term, there is likely to be increased public and professional debate, with potential confusion if FDA messaging diverges from established guidelines. Long-term, a shift in FDA policy could lead to broader clinical practice changes, with increased use of MHT if risks are officially deemed overstated. Women experiencing menopause may gain improved access to therapies and more balanced information, while healthcare providers face new guidance and patient expectations.

The Broader Impact on Women’s Health

The economic implications could include growth in the menopause therapy market, while socially, the destigmatization of menopause and its treatments may occur. However, there could be backlash from groups concerned about drug safety. Politically, the FDA’s credibility and leadership may be tested, especially if Makary’s approach is seen as too radical or insufficiently evidence-based.

Industry experts have mixed opinions, with some criticizing Makary for ignoring or misrepresenting established guidelines and lacking direct expertise in menopause care. Others welcome the re-examination of evidence, arguing that many women have been denied effective treatment due to exaggerated risk fears. The outcome of this debate could set a precedent for re-evaluating other treatments where risk perceptions may be outdated.