In May 2025, the administration published an executive order regarding most favored nation (“MFN”) drug pricing, which is sometimes referred to as “international reference pricing.” This executive order directs the Secretary of HHS to communicate MFN price targets to pharmaceutical manufacturers and, if significant progress toward MFN pricing is not delivered, to propose a rulemaking plan to implement MFN pricing. Recently, on December 23, 2025, CMS issued proposed regulations to establish, under the Center for Medicare and Medicaid Innovation, two mandatory MFN pricing demonstration models under Medicare Part B and Part D. If these rules or other MFN pricing rules are finalized, they are likely to mandate reduced pricing of at least some of the drugs and biologics in the United States if they are also sold in comparator countries.
