On Health Policy Archives

Letter from Experts to CMS and HHS Regarding Data Sharing in Leqembi Registries

July 27, 2023: In a letter to CMS and HHS, policy experts and bioethicists urge CMS to require that registries that make Medicare patients eligible for Leqembi coverage share data with CMS, FDA, and independent researchers to ensure accurate and unbiased data.

Testimony of Dr. Diana Zuckerman On Bill H.3948

July 26, 2023: We provided written testimony in support of Massachusetts bill H 3948, which would prohibit state and municipal contracts to install artificial turf fields. In October, the bill was reported favorably.

NCHR Comments on the FDA Notice Regarding Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies (REMS)

July 19, 2023: NCHR urged FDA to require drug sponsors and their REMS administrators to test proposed changes to REMS systems prior to implementation. FDA should also require stakeholder input from prescribers in all stages of developing, implementing, and tracking a REMS modification.

Patient, Consumer, and Public Health Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings

July 7, 2023: The Coalition expressed our 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.

NCHR Comments on FDA’s Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising

June 26, 2023: In our public comment, NCHR supports the FDA’s survey on evaluating patients’ understanding of quantitative information provided in prescription drug advertising. We strongly recommend adding an assessment of comprehension for factors such as relative risk, absolute risk, relative benefit, and absolute benefit of drugs. We urge the FDA to include a diverse demographic of participants in the one-on-one interview informing the survey and provide details about the number of interviews OPDP plans to conduct.