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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NCHR Testimony at D.C. Council Public Oversight Roundtable on Environmental and Safety Hazards on DPR Properties

May 05, 2025: NCHR’s Tess Robertson-Neel testified at a D.C. Council roundtable about environmental and safety hazards in DC parks and playgrounds. We highlighted concerns about heat-related injuries, other injuries and serious harms, and the presence of lead, PFAS and other harmful chemicals and metals in artificial turf and playground surfaces. Artificial turf and rubber playground surfaces have serious risks that can endanger children’s health. We urged the D.C. council to invest in safer, healthier alternatives.

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Public Comment of National Center for Health Research Regarding Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway

March 10, 2025: National Center for Health Research supports FDA’s decision to require that a confirmatory trial is “underway” before granting accelerated approval, but the definition of underway needs to be defined stringently and clearly. In our written public comment, we recommended setting specific benchmarks and stronger oversight to ensure timely trial completion so that patients and physicians can make informed medical decisions about products approved under the accelerated program. We also state that the closer to completion the confirmatory trial is at the time of accelerated approval, the more useful the research evidence is likely to be. We also urge that no exceptions be made to the requirement.

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