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October 30, 2020
Dear International Colleague,
FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order
The following statement was released by FDA Commissioner Stephen M. Hahn, M.D.
As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency. A recent executive order directed the agency, in consultation with federal partners, 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.
Over the past several weeks, the FDA has worked, in consultation with other federal partners, to develop a list of 223 drug and biological product essential medicines and medical countermeasures. Additionally, 96 device medical countermeasures are included on the list. These devices include 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.
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 and 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.
More information on the list, as well as an opportunity to submit comment, is available through Regulations.gov.
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, we encourage them to consider adopting advanced manufacturing technologies.
The FDA will continue to collaborate with the Department of Health and Human Services and other federal partners on this issue as directed by the executive order.
Additional Resources:
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