Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States
Executive Order 13944, signed August 6, 2020, directs the Federal government to strengthen the United States’ ability to respond to public health emergencies and national security threats by ensuring essential medicines, medical countermeasures, and critical inputs are produced domestically. It pushes agencies to accelerate domestic production, create stable long-term demand for US-made products, identify weaknesses in the supply chain, and use authorities such as the Defense Production Act to prioritize and allocate these items to support national defense. The order also expands oversight (through reporting and coordination with agencies) and aims to curb counterfeit or non-US sources by encouraging domestic procurement and tightening trade and regulatory pathways where feasible. It explicitly builds in exceptions for public interests and emergencies and provides a framework for balancing security with affordable access. In short, the order seeks to reduce dependence on foreign suppliers for vital health products, speed up domestic manufacturing capabilities, and align trade, regulatory, and procurement policies to maintain ready and reliable domestic stockpiles of essential medicines and related inputs.
Key Points
- 1Strengthen and prioritize a domestic Public Health Industrial Base: Agencies should increase procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs produced in the United States, with options to limit competition to US-made goods and to split contracts among multiple US manufacturers when appropriate.
- 2Identify vulnerabilities and accelerate domestic production: Within specified timeframes, the order requires action to map supply-chain weaknesses, collect information from manufacturers (e.g., sources of inputs, last FDA inspection), and accelerate FDA approvals for domestic producers. It also directs more (unannounced) facility inspections and potential rejection of imports from facilities that refuse inspections.
- 3Create and use lists of essential items: The FDA, with other agencies, must identify which medicines, countermeasures, and inputs are medically necessary to have at all times. A defense-focused subset will be identified for military needs. These lists drive procurement, regulatory, and trade actions.
- 4Trade, regulatory, and defense toolset: The U.S. Trade Representative will adjust federal procurement coverage under trade agreements to exclude essential items (and update as the FDA list changes). The Department of Defense may restrict procurement to domestic sources in defense-relevant cases. Exceptions exist for public interest, lack of sufficient US production, or cost increases within limits.
- 5Regulatory streamlining and prioritization: The order directs streamlining of regulatory requirements (e.g., EPA actions to speed siting and permitting for Advanced Manufacturing facilities) and uses the Defense Production Act to prioritize government contracts and allocate these materials to support national defense.