May 16, 2022 | Featured, Letters Submitted
We appreciate the work of the Senate Committee on Health, Education, Labor, and Pensions (HELP) in reauthorizing the Food and Drug Administration’s (FDA) user fee programs for generic drugs (GDUFA). The improvements in GDUFA III will speed patient access to safe,...
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Mar 8, 2022 | Letters Submitted
Patients Rising Now supports to provisions on the proposed rule to lower out of pocket Medicare Part D prescription drug costs and improve transparency, the patient voice, and health equity in Medicare Advantage (MA) and Part D. Read the Comments Letter ...
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Feb 7, 2022 | Letters Submitted
We have serious concerns about CMS’s draft national coverage determination (NCD) – issued January 11, 2022 – to limit Medicare coverage for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease (AD) to patients enrolled in...
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Jan 7, 2022 | FDA, Letters Submitted
The FDA’s Accelerated Approval Program provides a path for earlier approval of drugs being developed to treat serious diseases and address unmet medical need. The process allows the use of a surrogate endpoint—an indirect marker of clinical benefit that allows the...
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Jan 7, 2022 | FDA, Letters Submitted
On behalf of Patients Rising, the organization representing millions of Americans living with chronic disease, I write to support the nomination of Dr. Robert Califf to serve as Commissioner of the Food and Drug Administration. The U.S. Food and Drug Administration...
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Mar 26, 2021 | Copay Accumulators, Federal Issues, Letters Submitted
On January 20, the Biden administration issued a “regulatory freeze” memo asking agencies to consider postponing rules that have been published in the Federal Register but have not yet taken effect and open a 30-day comment period. This would allow President Biden’s...
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