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.| 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.| Patient, Consumer, and Public Health Coalition
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.| Patient, Consumer, and Public Health Coalition
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.| Patient, Consumer, and Public Health Coalition
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.| Patient, Consumer, and Public Health Coalition
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.| Patient, Consumer, and Public Health Coalition
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.| Patient, Consumer, and Public Health Coalition
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.| Patient, Consumer, and Public Health Coalition
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.| Patient, Consumer, and Public Health Coalition
The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals are erroneously categorized as Consumer Representatives on FDA Advisory Committees.| Patient, Consumer, and Public Health Coalition