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Food and Drug Law Journal ; 76(2):235-269, 2021.
Article in English | Web of Science | ID: covidwho-1535769

ABSTRACT

As the COVID-19 pandemic roiled the global economy, significant disruptions to the flow of goods and raw materials between countries emerged. Serious medical product shortages exposed the degree to which the United States relies on foreign suppliers of active pharmaceutical ingredients (API), finished pharmaceuticals, and other indispensable medical products and components. Concern about the fragility of medical product supply chains has generated rare bipartisan consensus, as policymakers of all stripes have called for measures to reduce the country's heavy dependence on foreign manufacturers. This Article begins by briefly discussing the root causes that have led many drug companies, API manufacturers, and device makers to move their operations abroad. It then outlines the potential national security and public health risks posed by the nation's significant dependence on foreign pharmaceutical and medical device suppliers. The Article also reviews measures taken during the COVID-19 pandemic to address medical product shortages, and how the pandemic has highlighted the need for comprehensive, long-term solutions to overreliance on foreign medical product manufacturing. The Article then addresses both the Trump and Biden administrations' approaches to strengthening domestic medical product manufacturing. It concludes by considering whether the current level of scrutiny and funding to address supply chain fragility will continue after COVID-19 is no longer an immediate threat.

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