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In Food and Drug Law Journal, Attorneys Analyze COVID-19 Impact on American Medical Product Supply Chain and Initiatives to Strengthen Supply Chain Security

Practices: Life Sciences, FDA Regulatory, Technology, Media & Telecommunications, Health Care

Capital Insights.

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 U.S. 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 have called for measures to reduce the country’s dependence on foreign manufacturers.

In the Food and Drug Law Institute’s Food and Drug Law Journal article by life sciences regulatory & compliance partner Greg Levine, counsel Beth Weinman and associate Jenna McCarthy (all of Washington, D.C.), the authors begin by 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.

Published with permission of FDLI and the Food and Drug Law Journal.

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