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 »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.
NCHR Comments on FDA’s Bioequivalency for Generic Drug Formulations Draft Guidance
July 18, 2023: FDA draft guidance on bioequivalency is intended to streamline generic drug development and speed up patients’ access to generic medications.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.
Read More »NCHR Comments on USPSTF Draft Recommendation on Breast Cancer Screening
June 6, 2023: The U.S. Preventive Services Task force has changed its recommendations for mammography to start at age 40 instead of 50. However, they still recommend mammograms every 2 years instead of every year. We point out that there are racial differences in cancer risk and that mammography guidelines should reflect those racial differences. One size does not fit all.
Read More »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.
Read More »NCHR Comments on FDA’s Patient-Focused Drug Development Draft Guidance
July 5, 2023: NCHR supports the FDA’s efforts to increase patient engagement in medical product development and emphasizes the need for diverse and representative samples, the importance of transparency in data analysis, and the use of COA-based endpoints in regulatory decision-making and drug labeling.
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