Reed Smith Client Alerts

On August 6, 2020, President Trump signed the “Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States” (EO)1. Most importantly, the EO directs executive departments and agencies involved in the procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs (each as defined, as further discussed below) to procure only those which are “produced in the United States” (also as defined and discussed below), except where an exception applies, such as unavailability.

The EO covers a number of important topics over 10 pages, raising issues relating to U.S. medical products industrial policy, government contracting, food and drug law, international trade and other areas. It includes specific requirements for the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Department of Defense (DoD), the U.S. Trade Representative (USTR) and the Environmental Protection Agency (EPA), outlining specific roles for the Director of the Office of Trade and Manufacturing Policy (currently Peter Navarro), the Assistant to the President for Economic Policy (currently Larry Kudlow) and the Office of Management and Budget (OMB), among others.

This client alert reviews the major provisions of the EO.

Authors: Robert J. Hill Cori Annapolen Goldberg Celeste A. Letourneau Michael J. Lowell Kevin M. Madagan Joseph W. Metro Holly A. Roth Jennifer A. Smokelin Elizabeth Leavy Sarah S. Wronsky John D. Kendzior Andrew Y. Lu Sung W. Park Janine R. Tougas Manasi Venkatesh

Closeup green-blue antibiotic capsule pills in blister pack

Policy and goals

The EO states that the United States must protect against “outbreaks of emerging infectious diseases and chemical, biological, radiological, and nuclear (CBRN) threats” and therefore “must have a strong Public Health Industrial Base with resilient domestic supply chains for Essential Medicines, Medical Countermeasures, and Critical Inputs deemed necessary for the United States.” Consequently, it “is critical that we reduce our dependence on foreign manufacturers ... to ensure sufficient and reliable long-term domestic production of these products, to minimize potential shortages, and to mobilize our Nation’s Public Health Industrial Base to respond to these threats.”

The EO states that it is the policy of the United States to:

  • Accelerate “the development of cost-effective and efficient domestic production of Essential Medicines and Medical Countermeasures and have adequate redundancy built into the domestic supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs”;
  • Ensure “long-term demand” for such products that are produced in the United States;
  • Create, maintain, and maximize domestic production capabilities for such products; and
  • Combat “the trafficking of counterfeit Essential Medicines, Medical Countermeasures, and Critical Inputs over e-commerce platforms and from third-party online sellers involved in the government procurement process.

The President is therefore directing each agency “to consider a variety of actions to increase their domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, and to identify vulnerabilities in our Nation’s supply chains for these products.”