On the State and Federal level, legislation is passed every year that affects our access to healthcare as well as the quality and affordability of our health care. We fight for legislation that will improve the health of all adults and children across the country.
September 4, 2025: Our Coalition comment urges that MDUFA VI prioritize patient safety over speed, ensure meaningful stakeholder participation in negotiations, and strengthen both pre- and post-market oversight.
Patient, Consumer, and Public Health Coalition Comment on the Reauthorization of MDUFA Read More »
August 14, 2025: The Patient, Consumer, and Public Health Coalition’s written comment discusses concerns about PDUFA reauthorization and urges the FDA to prioritize safety instead of just speed and to increase transparency and patient involvement.
August 4th, 2025: Tess Robertson-Neel testified on behalf of the Patient, Consumer, and Public Health Coalition at the FDA MDUFA Reauthorization Public Meeting. The coalition supports the reauthorization of MDUFA but made suggestions for making MDUFA more patient and public health centered.
FDA MDUFA Public Meeting Statement of Patient, Consumer, and Public Health Coalition Read More »
The Promising Pathways Act has no safeguards for protecting patients from drugs that have no benefits. It has the potential to greatly tarnish patients’ trust in the FDA and in new treatments approved by the FDA.
Coalition Letter to Senator braun regarding the Promising Pathways Act Read More »
It is essential that all data collected by any of the registries are made publicly available for research purposes, and all results are available to the public. We strongly urged CMS to make this a requirement as a condition of coverage.
Coalition letter to HHS and CMS Regarding the CMS Registry for Alzheimer’s Treatments Read More »
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.
Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings Read More »
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.
The Patient, Consumer, and Public Health Coalition, scheduled a hybrid meeting with FDA Commissioner Califf and other key FDA officials to discuss accelerated approval, reform to diagnostic lab developed test regulation, and improvements to FDA Advisory Committees.
February 27, 2023: The Coalition urges Congress to support the decision by the Centers for
Medicare and Medicaid Services (CMS) to limit the coverage of newly approved Alzheimer’s
drugs until the treatments have been shown to have a meaningful, clinical benefit that outweighs
the risks for the Medicare population.
We applaud your National Coverage Determination limited coverage of this class of drugs solely to patients participating in clinical trials following the approval of aducanamab (Aduhelm) by the FDA. The FDA approved Biogen and Eisai’s lecanemab today, and we urge you to hold firm to your decision to prioritize patient safety and the scientific credibility of CMS’s coverage decisions.
Coalition letter to CMS on Lecanemab approval and maintaining their coverage decision Read More »
