FDA Identifies Essential Medicines

FDA announced on Oct. 30, 2020 that it has identified a list of essential medicines, medical countermeasures, and critical inputs that should always be available in adequate amounts to protect against outbreaks of infectious diseases. The list was developed in response to an executive order issued in August 2020 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,” according to FDA.

The list, which was created in consultation with other federal FDA partners, includes 223 essential medicines and medical countermeasures and 96 device medical countermeasures. FDA identified essential medicines most needed for patients in acute care medical facilities. “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 agency stated in a press release. The agency identified APIs of essential medicines and medical countermeasures as critical inputs, “as well as ingredients or components that possess unique attributes essential in assessing the safety and effectiveness of such products.”

The agency will also coordinate with federal partners to develop strategies for acquiring products on the list, accelerate domestic manufacturing of these products, and investigate supply chain vulnerabilities. “The FDA believes that the adoption of innovative technologies, such as advanced manufacturing techniques could enable US-based pharmaceutical manufacturing to bolster its competitiveness with foreign countries and help ensure a stable supply of drugs critical to the health of US patients. As companies look to increase domestic manufacturing of the products on this list, we encourage them to consider adopting advanced manufacturing technologies,” FDA stated in the press release.