11/12/2025
Experts say the FDA removing the long-standing black box warning from menopause hormone drugs "sidestepped its usual public process."
Instead of an official public FDA Advisory Committee meeting, the FDA Commissioner invited a dozen doctors who already "overwhelmingly supported" the drugs.
NCHR President Dr. Diana Zuckerman said this undermines the FDA's credibility. The decision was announced on TV, “rather than having scientists scrutinize the research at an FDA scientific meeting."
The Commissioner claims the drugs reduce heart disease and Alzheimer's, but other experts say that evidence is "not as conclusive or definitive" as Makary claims. Our analysis says the evidence doesn't support his claims.
AP explains FDA to delete boxed warnings for menopausal hormone therapy. Diana Zuckerman says FDA lost credibility changing warnings without scientific review.