On Health Policy Archives

NCHR Comments on the FDA Draft Guidance on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics

May 26, 2023: FDA draft guidance contained numerous recommendations that would improve the quality of research submitted in support of accelerated approval for oncology drugs. However, we recommended the FDA explicitly specify that studies need to have a majority of patients enrolled prior to receiving accelerated approval and that they advise against the use of single-armed trials.

EPA Public Meeting on Proposed Rule to Reduce PFAS in Water

May 4, 2023: We provided a public comment at an EPA public meeting to support their proposed rule to reduce PFAS in water and suggested ways to strengthen the rule to save more lives by reducing limits on these carcinogenic chemicals.

NCHR comments on the FDA Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance

May 2, 2022: NCHR supports FDA’s draft guidance’s research design considerations to reduce bias in externally controlled trials.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.

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.

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.