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.
Devices
More than 95% of medical devices on the market were not required to be proven safe or effective. Less than 5% are required to be studied in clinical trials. Our goal is to improve the safety and effectiveness of all medical devices sold in the U.S. and educate healthcare professionals and patients about known and unknown benefits and risks of each device.
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 »
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 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Coalition comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions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.
Coalition Comments on the FDA Proposed Rule Regarding Laboratory Developed Tests
The Coalition supported the FDA proposed rule on lab-developed tests (LDTs) to diagnose diseases and genetic issues, with the exception of FDA’s proposed increased use of third-party reviewers.
Coalition Comments on the FDA Proposed Rule Regarding Laboratory Developed Tests Read More »
Coalition Letter to FDA regarding consumer representatives in Advisory Committees
The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals are erroneously categorized as Consumer Representatives on FDA Advisory Committees.
Coalition Letter to FDA regarding consumer representatives in Advisory Committees Read More »
Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings
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 »
Coalition comment to CMS on on CT Quality Measures Included in the Proposed Rule for the Hospital Inpatient Quality Reporting (IQR) Program
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.