Statement of Dr. Diana Zuckerman before the FDA Advisory Committees on Safety and Risk Management and Anesthetic and Analgesic Drug Products On Behalf of the National Center for Health Research

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.

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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.

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