F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause

The New York Times, November 10, 2025: This NYT article describes the different data and opinions regarding FDA Commissioner Makary’s decision to remove the black box from all hormone therapy products for menopause despite risks of cancer and stroke. NCHR president Dr. Diana Zuckerman explains why this is a step backward for women’s health.

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FDA ‘serious’ about hormone therapy changes

Politico, October 28, 2025: Politico predicts FDA will revise black box warnings on hormones for menopause, but it isn’t clear how. NCHR’s Diana Zuckerman explains warnings are needed but require more nuance because the evidence is different for hormone creams compared to pills, and evidence of risks and benefits for pills depend on factors such as the type of hormones and the age, medical history, and other differences in the women.

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Some MAHA Supporters Say CNPV Could Lower FDA Standards

Inside Health Policy, October 23, 2025: Inside Health Policy quotes a MAHA meeting that criticized industry influence over FDA, the impact of user fees, the inappropriate reliance on surrogate endpoints for cancer screening and Alzheimer’s drugs. The Lever FDA report finding that most new drugs are approved on evidence inferior to the FDA’s legal standards. NCHR’s Diana Zuckerman is quoted criticizing the FDA’s new CNVP program that promises extremely fast priority reviews for high-impact drugs.

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New Blood Tests for Early Cancer Detection Get Some Love From House Members

MedPage Today, September 18, 2025: This news article describes Energy & Commerce Health Committee hearing on bills that would require Medicare cover Breakthrough devices and controversial Multi-cancer Screening tests. NCHR president Dr. Diana Zuckerman testified, describing the cancer tests as “not ready for prime time” and explaining that the latest research shows they are very inaccurate, with some having a false positive rate over 90%

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