NCHR Public Comment Regarding the FDA’s Draft Guidance for the Study of Sex Differences in the Clinical Evaluation of Medical Products

April 7, 2025: NCHR responded to FDA’s request for public comments regarding its guidance on sex differences in studies used as the basis for FDA approval. We strongly support most of the FDA’s proposed guidance, but we note that the agency’s has never required adequate representation of both sexes and so has failed to ensure that all drugs and devices approved for males and females are proven to have benefits that outweigh the risks for both males and females. If products are not adequately tested on a meaningful number of females and males, they should not be approved for females and males.

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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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The FDA’s misguided thinking on antibiotics

STAT, February 10, 2025: Why are so many people dying from infections? In this op-ed, Diana Zuckerman and John Powers discuss that the main problem isn’t antimicrobial resistance; the problem is the way antibiotics are studied and approved. Research shows we can save lives with better studies and FDA approval standards that focus on patients and not bugs.

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