With Democrats now poised to gain control of both chambers of Congress, AMCP published the following deck to outline the impacts of the 2026 midterm election on federal health policy.
AMCP Comment Letter on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
In AMCP's latest comments to the FDA, we emphasize the need for standardized public reporting of confirmatory trial progress, ensuring payers and health care providers have the necessary data to make informed coverage decisions. By supporting proactive communication and rigorous confirmatory trials, AMCP aims to balance early access to innovative treatments with patient safety and long-term therapeutic value.
Related
Cell & Gene Therapies (CGT) offer potentially curative treatment to patients with chronic and hereditary conditions but carry high price tags. One proposal to overcome such financing challenges is to create a national risk pool.
The Academy of Managed Care Pharmacy (AMCP) thanks the Centers for Medicare & Medicaid Services (CMS) for the opportunity to provide comments in response to Medicare Drug Price Negotiation Program: Draft Guidance, Manufacturer Effectuation of the Maximum Fair Price in 2028 (Draft Guidance). CMS issued this draft guidance to describe the processes and requirements for manufacturer effectuation of the maximum fair price (MFP) in 2028 for selected drugs payable under Medicare Part B and/or covered under Medicare Part D.
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