March 9, 2022. We support the objective of this report, however, we agree with the report’s assessment that the “systematic review demonstrates a paucity of data to inform the effectiveness,” and there are several limitations in the data that are particularly problematic.
Read More »On Health Policy
Nonprofit Consumer and Public Health Organization’s Letter on MDUFA reauthorization to FDA and CDRH
February 22, 2022: We strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market safety performance measures and surveillance as part of the MDUFA Commitment Letter as you enter into final negotiations with industry. MDUFA performance goals should include metrics regarding safety, and not just speed of review.
Read More »NCHR’s Comments on USPSTF’s Draft Recommendation Statement on Behavioral Counseling to Reduce Cardiovascular Disease in Adults Without Known Risk Factors
February 14, 2022: Given the lack of evidence of a more meaningful benefit, we support the “C” grade recommendation that clinicians make decisions for these individual patients about whether to offer or refer them to behavioral counseling.
Read More »Public Comment PDUFA VII Commitment Letter (Docket #FDA-2021-N-0891) From the National Center for Health Research
October 28, 2021: NCHR comments on the proposed PDUFA VII Commitment Letter from the FDA.
Read More »Patient, Consumer, and Public Health Coalition Comment on CMS’s Proposed Decision Memo on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
February 10, 2022: As members of the Patient, Consumer, and Public Health Coalition, we strongly support the CMS proposed decision to limit the coverage of these drugs to patients participating in clinical trials, because it will provide the evidence needed regarding safety and effectiveness for the Medicare population.
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