A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics

Jeffrey N. Gibbs & Gail H. Javitt

“If we fail to learn from this global tragedy, we will have betrayed our nature as the animal-that-learns. We will have left this global disaster unredeemed, and we will be unprepared for the next.”[1]

Abstract

Addressing the COVID-19 pandemic has created many challenges for the Food and Drug Administration (FDA). One of the largest challenges in coping with COVID-19 has stemmed from the ongoing need for access to accurate diagnostic tests for the virus. FDA has well-established programs for reviewing in vitro diagnostic (IVD) tests. The agency also has had experience with accelerating the introduction of new IVDs in response to a public health emergency by granting Emergency Use Authorizations. However, no other new virus has overwhelmed FDA’s resources and decision-making capacity the way the novel coronavirus has. This Article examines FDA’s evolving approach to regulation of COVID-19 tests since the beginning of the pandemic, assesses the impact of FDA policies on IVD manufacturers and clinical laboratories and on the quality and availability of tests, and recommends areas for improvement. There is an urgent need for prompt FDA examination of its role in overseeing COVID-19 tests so the agency can evaluate what has gone well—and much has—and what can be improved. FDA should learn from COVID-19 how to regulate the new diagnostic tests needed for the next pandemic.

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