03 November 2020
A recent executive order directed FDA, 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.
The medical countermeasures are FDA-regulated products (biologics, drugs and devices) that meet the definition of a “medical countermeasure” provided in the executive order and that will be needed to respond to future pandemics, epidemics, and chemical, biological and radiological/nuclear threats.
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 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.
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