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