Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States
The order directs all federal agencies involved in pharmaceutical procurement to maximize domestic purchasing of essential medicines, medical countermeasures, and the critical ingredient inputs used to manufacture them — and instructs the FDA, Defense Department, U.S. Trade Representative, EPA, and others to take coordinated steps to reduce U.S. dependence on foreign drug manufacturers.
It establishes an implementation chain anchored by an FDA list of essential medicines that triggers trade-agreement modifications and defense procurement restrictions, building a framework aimed at preventing the kind of supply-chain disruptions that emerged during the COVID-19 pandemic.
What this order does
What it orders
The order directs federal agencies involved in pharmaceutical procurement to maximize domestic purchasing of essential medicines, medical countermeasures, and the critical ingredient inputs used to make them. It instructs the FDA Commissioner to publish an initial list of those products within 90 days, which then triggers the U.S. Trade Representative to modify trade-agreement procurement coverage to exclude the listed products and the Secretary of Defense to restrict military procurement to domestic sources. HHS and DoD must each assess supply chain vulnerabilities within 180 days, the EPA must streamline permitting for domestic manufacturing facilities, and agency heads must file annual procurement reports starting December 15, 2021.
The order includes exceptions when domestic supply is inadequate, when procurement costs would rise more than 25 percent, or when a declared public health or national emergency makes the restrictions impractical. A rule of construction explicitly preserves state and local governments' ability to procure resources during emergencies and protects veterans' access to affordable medicines.
Who it affects
Federal agencies that buy medicines, medical devices, or drug ingredients; domestic pharmaceutical and medical device manufacturers competing for expanded government contracts; foreign manufacturers whose products may be excluded from federal procurement; and veterans and military personnel whose drug access is explicitly protected by the order.
Why it matters
Federal agencies will be required to prefer domestically made drugs and ingredients, shifting purchasing patterns and potentially expanding domestic pharmaceutical manufacturing. Foreign suppliers currently used in government procurement face exclusion once the FDA finalizes its essential medicines list and the USTR modifies trade agreement coverage.
What must happen and when
How the order is supposed to work
The FDA Commissioner's list of essential medicines, due within 90 days, is the central trigger: USTR must modify trade agreement procurement coverage within 30 days of that list, and DoD must restrict military procurement to domestic sources within 60 days. Separately, agencies develop domestic procurement strategies within 90 days of signing and OMB reviews e-commerce platform authority in the same window. HHS and DoD complete vulnerability assessments within 180 days, and Commerce reports on the Public Health Industrial Base at the same deadline. Agency heads report procurement details to OMB annually starting December 15, 2021; waivers require written justification and annual reporting.
Actions and deadlines
- FDA Commissioner identify and publish initial list of essential medicines, medical countermeasures, and critical inputs
- OMB Director review agency authority to limit online procurement to compliant e-commerce platforms and report findings to the President
- Each agency head develop and implement domestic procurement strategies, including long-term contracts
- U.S. Trade Representative modify federal procurement product coverage under trade agreements to exclude listed essential medicines and critical inputs
- Secretary of Defense restrict procurement of essential medicines and critical inputs to domestic sources for national defense reasons
- Secretary of HHS identify and take action to mitigate supply chain vulnerabilities for essential medicines and critical inputs
- Secretary of Defense identify supply chain vulnerabilities for Armed Forces-specific essential medicines and critical inputs
- Secretary of Commerce submit report on Public Health Industrial Base status and recommended initiatives
- Agency heads submit annual report to the President detailing procurement of essential medicines, expenditures, sources, and domestic production plans