Patient, Consumer, and Public Health Coalition Comment on Hospital Outpatient Quality Reporting
September 12, 2025: PCPH Coalition comment urges CMS to maintain Outpatient Quality Reporting measures related to CT scans and excess radiation exposure.
Patient, Consumer, and Public Health Coalition Comment on the Reauthorization of MDUFA
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 »
Coalition Written Comment on the Reauthorization of the Prescription Drug User Fee Act 2025
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.
FDA MDUFA Public Meeting Statement of Patient, Consumer, and Public Health Coalition
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 »
Testimony of Patient, Consumer, and Public Health Coalition at Patient Engagement Device Advisory Committee Meeting
October 30, 2024: Tess Robertson Neel testified at the FDA Patient Engagement Device Advisory Panel on behalf of the Patient, Consumer, and Public Health Coalition regarding informed consent. We support the FDA’s proposed improvements, suggests a short, easy to read checklist format to improve fully informed consent, and highlights the need to enforce FDA recommendations or improve incentives for compliance.
Coalition Public Comment to CMS on Transcatheter Tricuspid Valve Replacement Coverage
FDA approval of TTVR was premature and the data are inadequate to support the safety and effectiveness of TTVR for the Medicare population. The Patient, Consumer, and Public Health Coalition urges CMS to conduct a thorough MEDCAC review prior to making a coverage decision.
Coalition Public Comment to CMS on Transcatheter Tricuspid Valve Replacement Coverage Read More »
Coalition follow-up letter to FDA regarding FDA overruling their own scientists
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 follow-up letter to FDA regarding FDA overruling their own scientists Read More »
Coalition Letter to Senator braun regarding the Promising Pathways Act
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 »
Coalition Comments to FDA on their Guidance for Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
In its public comment, members of the Patient, Consumer, Public Health Coalition told FDA that if a predicate device for 510(k) review does not align with the best practices identified in the FDA guidance, the device should be submitted to De novo or PMA instead.
Coalition comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
In its public comment, members of the Patient, Consumer, Public Health Coalition urged FDA to rely more on scientifically credible types of clinical data for 510(k) to ensure patients’ health and safety.