New York Times July 17, 2025: This FDA panel hosted by Commissioner Makary ignores evidence of the serious risks of hormone therapy for menopause, such as breast cancer, endometrial cancer, and stroke. Instead it focuses only on benefits, relying on misleading and erroneous information. The panel wants to remove the “black box” warning that tells women about the risks. No public comment was allowed at the meeting. We would have disagreed strongly, except with the issue of whether hormonal cream used in the vagina should not have the same black box warning as the hormonal pills.
Read More »Author: Caroline Bradford
NCHR Testimony regarding Front-of-Package Nutrition Information Labeling
July 15, 2025: NCHR submitted written comments to the U.S. Food and Drug Administration in support of the proposed rule on front-of-package nutrition labeling, recommending stronger, clearer labeling requirements, especially for young children. They suggested additional testing to ensure consumers understand and benefit from the labels, including those with limited literacy or English proficiency.
Read More »PDUFA VIII Statement of Dr. Amanda Berhaupt, Health Policy Director of NCHR
July 14, 2025: NCHR presentation at PDUFA July 2025 user fee meeting focuses on including patients and consumers in negotiations with FDA and industry and adding metrics to ensure post-market safety and meaningful clinical outcomes for prescription drugs.
Read More »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.
Read More »MIT Technology Review: Meet Jim O’Neill, the longevity enthusiast who is now RFK Jr.’s right-hand man
MIT Technology Review July 1, 2025: HHS Deputy Secretary Jim O’Neill wants unproven medical treatments to be very widely available and HHS to focus funding on longevity research so that those who can afford them can live much longer. This could include areas at sea or in states that are not subject to FDA safeguards. What will happen to the millions of Americans who need healthcare for diseases they already have?
Read More »