FDA publishes list of essential medicines and medical countermeasures

An executive order by President Trump in August instructed the US Food and Drug Administration to compile and published a list of essential medicines, medical countermeasures and critical inputs. The list identifies products that are medically necessary and therefore must be available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.

The FDA stated that the goal of the list is to ensure the American public is protected against outbreaks of emerging infectious diseases, as well as chemical, biological, radiological and nuclear threats. To accomplish this, the executive order seeks to ensure sufficient and reliable, long-term domestic production of these products and minimise potential shortages by reducing the US’s dependence on foreign manufacturers.

The list includes 223 essential medicines and medical countermeasures (both drug and biological products), as well as 96 device medical countermeasures. All of which are FDA-regulated products.  The devices listed include diagnostic testing kits and supplies for rapid test development and processing; personal protective equipment (PPE); vital sign monitoring devices; devices for vaccine delivery; and those for management of acute illnesses (eg, ventilators), among others.

The critical inputs listed include active pharmaceutical ingredients (APIs) for 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 same executive order also directs the FDA to coordinate with their federal partners on a number of additional issues, for example, developing strategies for acquiring the products on the list, accelerating domestic manufacturing and identifying and addressing supply chain vulnerabilities.