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.
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.
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 »
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 »
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 »
