The Food and Drug Administration (FDA) has developed a list of 223 drug and biological product essential medicines and medical countermeasures in order to prepare for future public health emergencies.
This action was in response to an executive order issued on August 6, 2020 aimed at protecting the public against outbreaks of emerging diseases and chemical, biological, radiological, and nuclear threats. In addition to these products, the Agency has identified 96 devices for inclusion, such as diagnostic kits, personal protective equipment and ventilators, among others. According to FDA Commissioner Stephen M Hahn, MD, the essential items included on the list were those that would be needed by patients in US acute care medical facilities to address severe injuries and urgent medical conditions.
Additionally, the executive order also calls for a reduction in dependence on foreign manufacturers for essential medicines and for an acceleration of domestic production of these products. To address these issues and help ensure a stable supply of critical drugs, the Agency pointed to advanced manufacturing techniques that could help US-based pharmaceutical manufacturers improve drug quality, accelerate drug development, and speed up availability of emerging therapies.
“As companies look to increase domestic manufacturing of the products on this list, we encourage them to consider adopting advanced manufacturing technologies,” said Hahn.
For more information visit fda.gov.
- Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs. [press release]. Silver Spring, MD; October 30, 2020.
- Drug and Biologic Essential Medicines, Medical Countermeasures, and Critical Inputs for the List Described in Section 3(c) of the Executive Order 13944. https://www.fda.gov/media/143406/download. Accessed November 2, 2020.