May 20, 2025: NCHR’s Amanda Berhaupt testified at the FDA Advisory Committee that since Glofitamab trial shows Asian patients with Diffuse Large B Cell Lymphoma patients do well but US and European patients do poorly and STARGLO had too few US patients to generalize results, the Genentech trial does not confirm safety and efficacy for DLBCL patients. The FDA Committee agreed.
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Testimony of Dr. Diana Zuckerman at the FDA Advisory Committee On Safety and Risk Management and Anesthetic and Analgesic Drug Products
May 5, 2025: NCHR president Dr. Diana Zuckerman testified at the FDA joint meeting of the Safety and Risk Management and Anesthetic and Analgesic Drugs Advisory Committee to discuss the OPC industry consortium new research results on the safety of extended release and long-term opioids. We criticized the biased definition of opioid use disorder (OUD) created by the industry consortium, which resulted in making long-term opioid use seem safer than it really is. We also criticized the labeling on all opioids for not accurately stating that opioids are not proven safe or effective for long-term use.
Read More »NCHR Comment on Medicare Coverage for Tricuspid Valve Transcatheter Edge-to-Edge Repair
May 2, 2025: The National Center for Health Research questions CMS’s proposed Coverage with Evidence Development for Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER), because it is not proven to save lives or reduce overall hospitalizations. We are also concerned about adverse events and problems with the research evidence used to support approval and coverage.
Read More »National Center for Health Research Comment on Medicare Coverage for Transcatheter Tricuspid Valve Replacement
January 18, 2025: National Center for Health Research questioned CMS’ proposed Medicare coverage with evidence development (CED coverage) for TTVR because the device isn’t proven to save lives or reduce hospitalization. In our written public comment, we said that patients’ quality of life is also very important, but it should be evaluated in an unbiased way that does not make a device seem more beneficial than it really is.
Read More »NCHR Comment on Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Falls and Fractures in Community-Dwelling Adults
January 21, 2025: NCHR written public comment supporting the conclusions drawn by the USPSTF and providing suggestions for improvements of their draft recommendation about Calcium, Vitamin D, and combined supplementation to prevent falls and fractures.
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