On April 15, President Trump issued an Executive Order titled “Lowering Drug Prices By Once Again Putting Americans First” and an accompanying “Fact Sheet: President Donald J. Trump Announces Actions to Lower Prescription Drug Prices.”  The President directs a wide range of drug pricing actions, including Inflation Reduction Act (IRA) Programs, Medicare Payment Model, Medicaid Drug Payments, Additional Drug Payment Actions, FDA Initiatives, PBM Reform, and Antitrust.  In this client alert, members of the Health Care and Food, Drug, and Device practice groups provide a “road map” to the actions contemplated under the Executive Order.

On May 12, 2025, President Trump issued an Executive Order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” and an accompanying “Fact Sheet: President Donald J. Trump Announces Actions to Put American Patients First by Lowering Drug Prices and Stopping Foreign Free-riding on American Pharmaceutical Innovation.”  The Executive Order criticizes the disparity between prices paid for drug products in foreign markets and the “enormously high prices” for the same drug products in the United States.  To “end global freeloading” and “inflated prices in the United States [that] fuel global innovation,” the Executive Order calls for most-favored-nation (“MFN”) pricing in the United States.  A multidisciplinary team outlines the Executive order’s key directives in this client alert.

On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) released a new draft guidance document for the Inflation Reduction Act’s (IRA’s) Medicare Drug Price “Negotiation” Program (the Program), entitled “Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028” (Guidance); see also Fact Sheet.  The Guidance represents the Trump Administration’s first opportunity to shape the policy of the Program.  The Guidance also implements two areas of expansion contemplated under the IRA: (1) the inclusion of negotiation eligible drugs payable under Medicare Part B, and (2) processes to allow for the renegotiation of MFPs for selected drugs.  In this client alert, members of the Health Care and Food, Drug, and Device practice groups summarize select new and updated Program policies.