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.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
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.
Read More »NCHR Comments on the FDA’s Use of Generally Accepted Medical Knowledge Draft Guidance
July 24, 2023: The FDA proposed a draft guidance on using generally accepted medical knowledge (GASK) when conducting nonclinical studies to help streamline product development, decrease costs, and hasten new product approval time. We do not recommend using GASK as the sole source of nonclinical data in new drug applications or biologic license applications as this could jeopardize the safety, toxicology, and efficacy of the product.
Read More »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.
Read More »NCHR Comments on FDA’s Bioequivalency for Generic Drug Formulations Draft Guidance
July 18, 2023: FDA draft guidance on bioequivalency is intended to streamline generic drug development and speed up patients’ access to generic medications. But some shortcuts that FDA proposes could result in unsafe generic medications that were not adequately tested. We highlight research standards that will help keep patients safe.
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