NCHR supports FDA’s draft guidance on studies needed for drugs intended to help adults and children with obesity or overweight with serious health problems, but we urge the FDA to require studies of 3 years rather than 1 year to ensure that the drugs are effective attaining and maintaining weight loss. In our written public comment, we also recommended that FDA require the research to include possible side effects and complications of long-term use or of discontinuation of use; require prior non-drug interventions before enrollment in a study of a weight loss drug (especially for children), and more rigorously analyze dropout data to determine the causes and analyses of missing data. These changes are crucial to ensure that patients and clinicians have the evidence they need to make informed, safe, and effective decisions.
Read More »Medical Care for Adults
The National Center for Health Research reviews important new research as soon as it is published. We cut through the hype regarding various medical treatments to let you know what is proven and what is unknown about the risks and benefits of various treatment options. We do not accept funding from the companies that make medical products, so you can trust that our information is based on science, and not biased by financial ties to the treatments we’re evaluating.
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NCHR Public Comment Regarding the FDA’s Draft Guidance for the Study of Sex Differences in the Clinical Evaluation of Medical Products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.
Read More »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 »As Trump Administration Probes Long-Approved Medications, Could FDA Revoke Approvals?
Medscape March 6, 2025: MAHA Commission will study psychiatric, ADHD, and weight loss drugs’ impact on children. NCHR’s Diana Zuckerman agrees we need better evidence that the benefits of these drugs outweigh the risks.
Read More »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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