On Health Policy Archives

Patient, Consumer, and Public Health Coalition Comment to CMS on CT Quality Measures Included in the Proposed Rule for the Hospital Inpatient Quality Reporting (IQR) Program

June 9, 2023: We support this CT quality measure because it establishes a floor and a ceiling to provide an optimal level of radiation exposure for imaging for numerous different conditions, without reducing the diagnostic benefits of those scans.

NCHR Comments on EPA Per- and Polyfluoroalkyl Substances National Primary Drinking Water Regulation

May 30, 2023: We agree that this proposed rule will improve public health, reducing cancer, heart disease, stroke, low birth weight, and other harms to adults and children. However, we have several recommendations to improve the proposed rule. The PFAS limit should be changed to 2 parts per trillion (ppt) and the EPA needs more explicit limits to prevent a weakening of these regulations. Finally, companies that produce PFAS should bear the financial burden.

NCHR Comments on the FDA Draft Guidance on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics

May 26, 2023: FDA draft guidance contained numerous recommendations that would improve the quality of research submitted in support of accelerated approval for oncology drugs.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on the FDA Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft Guidance

May 2, 2022: NCHR supports FDA’s draft guidance’s research design considerations to reduce bias in externally controlled trials.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