The FDA Commissioner Is Missing the Point of Advisory Committees

Diana Zuckerman’s oped in MedPage Today says FDA was never perfect but the media and public could see how the agency reviewed risks and benefits when they held public meetings where scientists and public citizens debated controversial medical products. In recent months they’ve switched to one-sided rubber stamp meetings followed by announcements of their decisions at events that feel like pep rallies. For example, research shows that hormones for menopause can be helpful or harmful, depending on your age and the type of hormones and your personal medical history. They are not safe for everyone, and can cause cancer, strokes, and dementia for many women. But the FDA expert panel focused on the benefits and ignored most of the risks.

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FDA Panel to Revisit Menopausal Hormone Therapy

Politico; July 15, 2025: This article describes the FDA panel on the risks and benefits of hormone therapy for menopause: breast cancer, heart disease,stroke, dementia. Zuckerman points out that the panel is one-sided, ignoring data on risks and not allowing public comments from patients or experts to ask questions or describe studies indicating cancer and other serious risks.

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The FDA’s misguided thinking on antibiotics

STAT, February 10, 2025: Why are so many people dying from infections? In this op-ed, Diana Zuckerman and John Powers discuss that the main problem isn’t antimicrobial resistance; the problem is the way antibiotics are studied and approved. Research shows we can save lives with better studies and FDA approval standards that focus on patients and not bugs.

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Medicare has different standards than the FDA. That’s how it should be

STAT News, February 2, 2024: NCHR’s Diana Zuckerman’s commentary in STAT News explains why Medicare should not pay for every medical product that FDA approves, since some are more likely to harm rather than help Medicare patients. She points out that FDA does not require diversity in clinical trials and rarely includes enough older and less healthy patients that tend to rely on Medicare.

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