AMCP Submits Comments on MCIT Rule

The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics” (Draft Guidance), issued on December 5, 2024.

The Academy of Managed Care Pharmacy (AMCP) issued the following statement from AMCP CEO Susan A. Cantrell, MHL, RPh, CAE, regarding President Trump’s new and proposed tariffs on U.S. imports from Canada, Mexico, and China: “Although President Trump’s new and proposed tariffs aim to level the playing field between American industries and our foreign competitors, we are concerned about the unintended, adverse consequences they may have on the cost of medicines in the U.S.

AMCP shared comments with Centers for Medicare & Medicaid Services (CMS) on the proposed 2026 Policy and Technical Changes to the Medicare Advantage (MA) Program. We applaud CMS’ efforts to address obesity and emphasized the importance of managing costs. AMCP urged CMS to issue guidance on managing drugs in this class to effectively treat obesity as a chronic disease. On the Medicare Transaction Facilitator, we advised CMS to avoid adding unnecessary costs and administrative burdens. We support CMS’ focus on increasing access to generics, biosimilars, and other affordable medications. Lastly, we provided insights on proposed changes to Star Ratings, ensuring member perspectives are represented.