Today, the Food and Drug Administration (FDA) published a list of essential drugs, medical countermeasures, and critical manufacturing inputs, such as active pharmaceutical ingredients. The list includes 223 drug and biological products and medical countermeasures, and an additional 96 device medical countermeasures. The list was required by a “Buy American” executive order signed by President Trump on Aug. 6. FDA has opened a docket for public comment on the list contents.
ASHP has advocated for the development of an essential medicines list as part of our longstanding efforts to address and end drug shortages. The development of an essential medicines list was a recommendation from both ASHP’s 2018 multi-stakeholder summit on drug shortages as well as the July 2020 Summit on Safe, Effective, and Accessible High-Quality Medicines as a Matter of National Security.
“ASHP applauds the development of a critical drugs list,” said Tom Kraus, ASHP Vice President of Government Relations. “Identifying life-saving and life-sustaining treatments is an important step in securing the pharmaceutical supply chain and ensuring our patients have uninterrupted access to high-quality medications.”
ASHP will submit comments to FDA's docket and will continue to update our members on agency action related to our drug supply chain.