Drugs

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...

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...

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...

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....

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...

Coalition comments Regarding the FDA Draft Guidance Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions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...

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...

Coalition Letter to FDA regarding consumer representatives in Advisory Committees

The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals...

Coalition letter to HHS and CMS Regarding the CMS Registry for Alzheimer's Treatments

It is essential that all data collected by any of the registries are made publicly available for research...

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...

February 10, 2022

Public Comments to CMS on Aduhelm for the treatment of Alzheimer’s disease

Patient, Consumer, and Public Health Coalition provides public comments on Aduhelm and similar medical products for the treatment of Alzheimer’s disease