Some MAHA Supporters Say CNPV Could Lower FDA Standards

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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Heart Disease in Women

Heart disease is the leading cause of death for U.S. women and men, but it often has different causes, symptoms, and risks for women, especially after menopause. Biological differences and the underrepresentation of women patients in cardiovascular research result in less effective prevention and treatment for women. Learn more about how early screening, exercise, and healthy habits can prevent disease, and the research needed to learn more about treating women with heart disease.

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NCHR Comments on Coverage of Colorectal Cancer Non-Invasive Biomarker Screening Tests

NCHR public comment tells CMS that the ColoSense multi-target mRNA stool-based colorectal cancer screening test needs better evidence to qualify for Medicare NCD coverage. The study sample included 3x the average number of smokers in the U.S. and since smoking increases the chances of colon cancer, that may have biased the results to make the test seem more accurate than it really is. Too many false positives or false negatives would make the test much less useful for patients.

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Breakthrough Devices

NCHR analysis of FDA breakthrough devices, their approval pathways, and the evidence available for safety and effectiveness.

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