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.
Read More »On Health Policy
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.
Read More »National Center for Health Research Public Comment on FDA Draft Guidance: Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics
February 4, 2025: In our written public comment, we urged FDA to improve its draft guidance on the accelerated approval process by requiring and enforcing timely confirmatory trials proving meaningful clinical benefit based on validated measures of overall survival and quality of life.
Read More »NCHR Public Comment on FDA Voluntary Sodium Reduction Goals
January 13, 2025: FDA has drafted new targets to reduce the high levels of sodium (salt) in Americans’ diet. NCHR urged the FDA to lower voluntary sodium targets for restaurants and food companies so that they meet the recommended maximum daily consumption. If voluntary targets aren’t met, NCHR told the FDA that targets should be mandatory in order to save lives.
Read More »Invited Panel Presentation of Dr. Diana Zuckerman at FDA OMUFA Meeting
November 20, 2024: We were invited to present at the FDA OMUFA November 2024 meeting on the OTC user fee program commitment letter. We appreciate the priority given to safety OMORs (Monograph revisions) but are concerned that the funding is focused on speed of reviews and industry access to FDA staff, not to pay for staff to conduct FDA safety reviews of OTC medications being sold for years without evidence of safety and effectiveness. OTC products will be safer if consumers and public health experts are present when negotiations take place.
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