On August 6, 2020, President Trump signed an Executive Order (“Order”) to ensure essential medicines, medical countermeasures, and critical inputs are made in the United States. The President recognized that reliable domestic supply chains for Essential Medicines, Medical Countermeasures, and Critical Inputs are necessary for the preparedness and protection of United States citizens. The Order is intended to increase domestic production of essential medicines, medical equipment and protective gear in order to decrease the country’s reliance on foreign drug and medical device manufacturing. The Order also seeks to combat counterfeit products. The federal government will be required to develop a list of essential medicines and shift their procurement to U.S. based manufacturing companies.
The Office of Management and Budget is directed, in consultation with the heads of different Agency, to review each agencies’ authority to limit procurement of products to e-commerce platforms that have agreed to requirements combating the sale of counterfeit goods.
Such changes, if implemented provide for fundamental changes in existing regulatory requirements and require significant revisions to U.S. law and international agreements. Given the significant nature of the actions that are required to be implemented and the relatively short deadlines, it is not clear whether the administration can meet these deadlines. If and when implementation begins (and only after the November presidential election) can we assess the impact of any changes to procurement and the supply chain. It is likely that the sweeping changes under the Order will face significant legal challenges under the Administrative Procedures Act from many impacted parties.
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