FDA publishes list of essential medicines, devices

Regulatory NewsRegulatory News | 02 November 2020 |  By 

To comply with a recent executive order, the US Food and Drug Administration (FDA) on Friday released a list of more than 300 essential drugs and medical devices that will serve as a basis for prioritized federal procurement of those products from domestic sources.
The list was developed in response to President Donald Trump’s “Buy American” executive order, issued in August, aimed at boosting domestic production of drugs and medical devices. (RELATED: Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices, Regulatory Focus 7 August 2020).
In total, the list includes 223 drugs and biological products and 96 medical devices and in vitro diagnostics deemed “medically necessary to have available at all times,” in adequate supply and in appropriate dosage forms. The drugs and devices included on the list include common hospital drugs, many of which are currently in shortage, and devices such as ventilators, infusion pumps, personal protective equipment and diagnostics for a variety of infectious diseases.
The list also specifies the critical inputs, such as active pharmaceutical ingredients (API) or sensor components, necessary to produce each product.
“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,” said FDA Commissioner Stephen Hahn.
FDA says it developed the list in consultation with other federal agencies and will continue working with its federal partners to develop strategies to procure products included on the list and to promote domestic manufacturing.
Now that the list has been published, the US Trade Representative is tasked with excluding the products from coverage under the World Trade Organization Agreement on Government Procurement and other relevant free trade agreements.
The agency has also opened a public docket seeking comments on the criteria used for the list, whether products should be added or removed and on the process the agency should use to periodically review the list.
FDA, Statement


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy