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.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
NCHR Written Comment on FDA’s Review of the Galleri Multi-Cancer Early Detection Test
September 8, 2026: In response to a request for public comments, NCHR urged the FDA not to approve Galleri multi-cancer screening blood test until it is proven to help patients live longer or improve their quality of life. Its accuracy must be improved to show its benefits outweigh the physical, emotional, and financial burdens of inaccurate results and follow-up testing. NCHR also emphasized Galleri’s limited sensitivity, particularly for early-stage cancers, and warned that it should not replace recommended cancer screenings.
Read More »Dr. Diana Zuckerman’s Public Comment at the FDA Meeting for Reauthorization of the Prescription Drug User Fee Act (PDUFA)
September 16, 2026: Diana Zuckerman of National Center for Health Research criticizes FDA PDUFA commitment letter for prioritizing speed of approval instead of making sure drugs are safe and effective.
Read More »Are Medical Devices Proven to Work?
Medical Devices Need User Fees to Improve Evidence
On an FDA panel on MDUFA user fees, NCHR President Dr. Diana Zuckerman told the FDA that industry fees should support FDA staff to ensure devices are safe and effective for all patients before and after they get on the market.
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