Oral Statement of Dr. Diana Zuckerman at the FDA Advisory Panel Meeting on the Galleri Multi-Cancer Screening Test on September 24, 2026

September 23, 2026: NCHR’s Diana Zuckerman testifies at FDA panel meeting on Galleri multi-cancer screening test, stating that the test fails to accurate predict early cancers. The test misses more early cancers than a coin toss, and those false negatives can lead to patients delaying medical visits when symptoms appear. Those delays can be deadly. Though the test is less likely to tell people they have cancer when they don’t, those who are misinformed will undergo many weeks of anxiety as well as additional, often invasive tests. Most important, there is no evidence that the test saves lives or improves quality of life, since most cancers detected are late stage.

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Stakeholders Letter from National Center for Health Research, Doctors for America, Generation Patient, and U.S. PIRG to FDA PDUFA Negotiators

April 17, 2026: National Center for Health Research and Stakeholder partners wrote to FDA PDUFA user fees negotiators to express our concerns that FDA had ignored our repeated requests for PDFUA to include performance goals aimed at improving scientific standards and evidence that will ensure that drugs and biologics have meaningful benefits for patients that outweigh any risks.

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NCHR Written Comment on HHS National Plan To Address Alzheimer’s Disease

August 14, 2026: In response to a request for public comments, NCHR urged HHS to strengthen the ‘National Plan to Address Alzheimer’s Disease’ by improving research that directly informs patient care, treatment decisions, and quality of life for people living with AD/ADRD. We recommend requiring NIH to immediately analyze CMS registry data on Leqembi and Kisunla, and require the other anti-amyloid registries to make data available to HHS for NIA and NINDS to analyze the data and make it public. NCHR also called for stronger oversight of potentially deadly antipsychotic medications used for dementia patients and greater support for patients, families, and caregivers.

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Public Comment of Generation Patient, National Center for Health Research, Patient Safety Action Network, and USA Patient Network in response to the Medical Device User Fees Amendments (MDUFA) VI Stakeholders Process and Commitment Letter

August 7, 2026. In response to a request for public comments by the FDA on proposed recommendations for reauthorizing the Medical Device User Fee Amendments (MDUFA) VI for fiscal years 2028–2032, the National Center for Health Research urged the FDA to improve the FDA’s Commitment letter with industry to ensure clinical trial results are available in clinicaltrials.gov prior to devices going on the market, provide resources for post-market surveillance, and reduce industry demands on deficiency letters.

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