On August 6, 2020, the President issued an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. This executive order directed the U.S. Food and Drug Administration (FDA) to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.
The goal of this work is to ensure the American public is protected against outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological, and nuclear threats. To accomplish this goal, the executive order seeks to ensure sufficient and reliable, long-term domestic production of these products, and to minimize potential shortages by reducing our dependence on foreign manufacturers of these products.
The executive order also directs the FDA to coordinate with our federal partners on a number of additional issues, including strategies for acquiring the products on the list, accelerating domestic manufacturing, and identifying and addressing supply chain vulnerabilities. The FDA is working on this coordination. The FDA believes that the adoption of innovative technologies, such as advanced manufacturing techniques, could enable U.S.-based pharmaceutical manufacturing to bolster its competitiveness with foreign countries and help ensure a stable supply of drugs critical to the health of U.S. patients. As companies look to increase domestic manufacturing of the products on this list, they are encouraged to consider adopting advanced manufacturing technologies.
The FDA will continue to collaborate with the Department of Health and Human Services (HHS) and other federal partners on this issue as directed by the executive order.
The list includes:
- Drug and Biologic Essential Medicines, Medical Countermeasures, and Critical Inputs for the List Described in Section 3(c) of the Executive Order 13944
- Device Medical Countermeasures and Critical Inputs for the List Described in Section 3(c) of the Executive Order 13944
The FDA has worked, in consultation with other federal partners, to develop a list of drug and biological product essential medicines and medical countermeasures. Additionally, device medical countermeasures are included on the list.
Generally, the essential medicines we identified are those that are most needed for patients in U.S. acute care medical facilities, which specialize in short-term treatment for severe injuries or illnesses, and urgent medical conditions. The medical countermeasures we identified are FDA-regulated products (biologics, drugs, devices) that meet the definition of a "medical countermeasure" provided in the executive order and that we anticipate will be needed to respond to future pandemics, epidemics, and chemical, biological, and radiological/nuclear threats. When identifying essential medicines and medical countermeasures, we focused on including those that are medically necessary to have available in adequate supply which can be used for the widest populations to have the greatest potential impact on public health.
The critical inputs we identified include active pharmaceutical ingredients of essential medicines and medical countermeasures, as well as ingredients or components that possess unique attributes essential in assessing the safety and effectiveness of such products.
The device medical countermeasure list includes diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, active vital sign monitoring devices, devices for vaccine delivery, and devices for management of acute illnesses such as ventilators, among others.
The criteria FDA used to identify essential medicines, medical countermeasures, and critical inputs are available here: Criteria For Identifying Human Drug and Biologic Essential Medicines, Medical Countermeasures, and Critical Inputs for the List Described in Section 3(c) of the Executive Order (EO) 13944 (PDF, 126KB)
FDA has opened a public docket for stakeholders to offer specific comments on the following questions.
- Do you have any feedback on the criteria developed by the FDA for inclusion of essential medicines, medical countermeasures, or their critical inputs on the list required by Executive Order 13944?
- Are there any additional essential medicines, medical countermeasures, or critical inputs you believe should be included on the list or ones you think should be removed and why?
- Do you have any feedback on how frequently, and by what type of process, the list should be evaluated to determine the need for any additions or removals?
Please submit all comments to the public docket (FDA-2020-N-2123, available at Regulations.gov).
For media inquiries about this list, contact: FDAOMA@fda.hhs.gov
For all other questions about this list, contact: EssentialMedicinesEO@fda.hhs.gov
- August 6, 2020: Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (White House)
- October 30, 2020: FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order
- Advanced Manufacturing – Learn more about FDA’s advanced manufacturing activities to support public health emergency preparedness and response
- Counterterrorism and Emerging Threats