STAT News, February 2, 2024: NCHR’s Diana Zuckerman’s commentary in STAT News explains why Medicare should not pay for every medical product that FDA approves, since some are more likely to harm rather than help Medicare patients. She points out that FDA does not require diversity in clinical trials and rarely includes enough older and less healthy patients that tend to rely on Medicare.
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Coalition follow-up letter to FDA regarding FDA overruling their own scientists
February 5, 2024: The Patient, Consumer, and Public Health Coalition expressed their strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
Read More »Coalition follow-up letter to FDA regarding FDA overruling their own scientists
February 5, 2024: The Patient, Consumer, and Public Health Coalition expressed their strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
Read More »NCHR Provides Recommendations for the Public Meeting Agenda to Reduce Added Sugar Consumption in the United States
January 22, 2024: NCHR recommends that FDA policies are discussed as a key strategy to reduce added sugar consumption at the national public meeting on hunger. The FDA should require targets for added sugar amounts in packaged food, hold restaurants accountable for disclosing added sugar content, and regulate food with artificial sweeteners.
Read More »NCHR Public Comment on Communications From Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved Medical Products
December 26, 2023: We responded to the FDA’s request for public comment about the scientific information (SIUU) that firms can provide to healthcare providers about the unapproved uses of approved medical products. Promotion for unapproved (off label) uses were prohibited years ago, but that has been loosened over the decades and the FDA’s new draft guidance is worrisome because it is not as specific as it should be about how to ensure that the information the companies provide is accurate and not misleading. We agree with some of the guidance but urge more careful wording to ban the use of poor quality data and misinterpretation.
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