On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” This executive order aims to lower the cost of prescription drugs for U.S. consumers by requiring drug manufacturers to sell their products to consumers at a most-favored-nation price through direct-to-consumer purchasing programs facilitated by the Secretary of Health and Human Services (“HHS”). Under the proposed most-favored-nation approach, consumers would pay no more than the lowest price for a prescription drug sold by a drug manufacturer to customers in comparably developed nations.
The executive order directs HHS to take steps to implement a most-favored-nation approach to prescription drug pricing. This includes communicating most-favored-nation price targets to pharmaceutical manufacturers within 30 days. If “significant progress” towards implementing the most-favored-nation approach is not made, the executive order directs HHS to, among other things, propose a rulemaking plan to impose most-favored-nation pricing. The executive order does not specify a timeline for measuring “significant progress.” The executive order states that if drug manufacturers fail to implement most-favored-nation pricing, the Administration will take “additional aggressive action.”
The executive order also authorizes other executive branch agencies (e.g., the Food and Drug Administration) to take certain other actions should significant progress towards implementing the most-favored-nation approach not be made. This includes enforcement actions against any anti-competitive practices identified pursuant to the April 15, 2025 executive order and the modification or revocation of approvals granted for drugs identified as unsafe, ineffective or improperly marketed.
This executive order marks a continuation of President Trump’s efforts to implement most-favored-nation drug pricing. President Trump signed a similar executive order on September 13, 2020 during his first term, attempting to implement the most-favored-nation approach to prescription drugs covered under Medicare Parts B and D. However, the executive order was blocked by federal courts and the proposed model interim final rule implementing most-favored-nation drug pricing was withdrawn by the Biden Administration in December 2021.
The health care attorneys at Vedder Price will continue to monitor regulatory developments resulting from this executive order. If you have any questions, please contact Jeremy M. Alexander at jmalexander@vedderprice.com or any of the Vedder Price attorneys with whom you normally work.