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In Food and Drug Law Journal, Jonathan Iwry Examines FDA Emergency Use Authorization Historical Lessons

Practices: Life Sciences, Health Care, FDA Regulatory, Biomedical Research: Human, Animal and Bench Science, Technology, Media & Telecommunications, Risk Management

In Food and Drug Law Institute’s Food and Drug Law Journal article, corporate associate Jonathan Iwry (Boston) offers a history and analysis of the U.S. Food and Drug Administration’s power to authorize vaccines and other medical products on an emergency basis. The COVID-19 pandemic has thrown a spotlight on FDA emergency use authorization, which has become even more prominent after being used to authorize three COVID-19 vaccines in the U.S. in 2020 and 2021. 

The article first reviews the history of FDA emergency use authorization from its inception up to its present-day use against COVID-19, and then analyzes the policy and ethical issues bearing on FDA’s use of its emergency powers in authorizing products such as diagnostic tests, drug products, and vaccines. It considers possible frameworks to guide FDA decision making in order to maximize consistency and transparency in its use of EUAs. It concludes by considering the sorts of issues likely to recur when using EUAs in emergencies beyond COVID-19. 

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

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