May 2, 2022: NCHR supports FDA’s draft guidance’s research design considerations to reduce bias in externally controlled trials. However, FDA should be much more explicit about the criteria that must be met to ensure that externally controlled trials are only used when absolutely necessary.
Read More »On Health Policy
NCHR’s Comments on AHRQ’s Draft Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain and Subacute Pain
April 20, 2023: NCHR supports the goals of the review and agrees that there is a need for a systematic review of the effects of cannabis and other plant-based treatments for chronic pain. However, there are several important limitations of the report that were either not adequately addressed.
Read More »Testimony of Diana Zuckerman at the FDA Advisory Committee Meeting on Extended-Release/Long-Acting Opioid Analgesics Post-marketing Requirements
April 19, 2023: FDA has worked with industry to propose a clinical trial to determine safety and efficacy of extended release (ERLA) opioids for chronic pain. We criticized the proposed study due to bias, poor study design, and ethical considerations for patients who could be harmed by the study. We urge the FDA to revise the labels to restrict the use of these opioids for chronic pain, based on current data and not wait for what could be an inevitably flawed study to be completed.
Read More »NCHR Comments on the CMS Inflation Reduction Act Initial Program Guidance
April 14, 2023: NCHR comment on the CMS plan to fully implement the authorities provided by Congress in the Inflation Reduction Act (Pub. L. 117-169) to lower the costs of prescription drugs for beneficiaries through drug price negotiations.
Read More »FDA Accelerated Approval Pathway: Controversies and Reform
Recent controversies of drugs granted accelerated approval have raised important questions about the evidence needed to determine whether the benefits outweigh the risks in the short-term or the long-term, and what can be done to improve the pathway.
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