FDA issues list of essential medicines and countermeasures required under Buy American Executive Order

Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced today that it published a list of 223 drug and biological product essential medicines and medical countermeasures, as well as 96 device medical countermeasures; the list is online here. FDA also published its criteria for inclusion in the list, and seeks public comment on these criteria and on the list itself.

FDA stated that the essential medicines listed are those that are “most needed for patients in U.S. acute care medical facilities, which specialize in short-term treatment for severe injuries or illnesses, and urgent medical conditions.” FDA did not include drugs for “longer-term chronic management, including those needed to cure a condition through weeks or months of outpatient treatment.” The medical countermeasures on the list are those that meet the definition of the term in the Executive Order and that FDA anticipateswill be needed to respond to future pandemics, epidemics, and chemical, biological, and radiological/nuclear threats.” In deciding which essential medicines and medical countermeasures to include, FDA “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.”

FDA was directed to compile these lists per the terms of the Executive Order (EO). The order directs that the U.S. government take action to support and encourage manufacture of these products in the United States. It directs Federal agencies to apply preferences in U.S. government procurements to domestic products that are included on the lists. Additionally, the order directs that products on these lists be withdrawn from the World Trade Organization International Agreement on Government Procurement and any other relevant trade agreements, to allow for application of the “Buy American” restrictions US government procurements.

Moreover, a consequence (perhaps unintended) of the EO is that, if implemented, the U.S. government will be permitted to buy drugs and medical devices (within the categories included on the lists) that are made in China and India. Purchases of drug products from these countries largely have been restricted, as these countries are considered ineligible “nondesignated countries.”

In terms of next steps, the U.S. trade representative now has 30 days to exclude the listed products from the WTO Agreement on Government Procurement (GPA) and any relevant trade agreements, which could result trading partners taking similar actions to limit their markets to U.S. products. The Department of Defense also has 60 days to restrict the procurement of certain products identified by FDA to domestic sources.

Drug and medical device companies with products that are included on these lists should consider whether application of the order’s Buy American preferences may be impactful in the context of their Federal business. If you have any questions about the product listing or the Executive Order, more generally, please do not hesitate to reach out to our Life Sciences Government Contracts and International Trade Team.

 

Authored by Joy Sturm, David Horowitz, Allison Pugsley, Kelly Ann Shaw, David Burgett, and Ryan Harrigan

 

 

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