Regulatory Reactivity: FDA and the Response to COVID-19

20 Pages Posted: 28 Aug 2020 Last revised: 14 Mar 2022

See all articles by Yaniv Heled

Yaniv Heled

Georgia State University College of Law

Ana Santos Rutschman

Villanova University - Charles Widger School of Law

Liza Vertinsky

University of Maryland Carey School of Law

Date Written: August 25, 2020

Abstract

Public health-oriented agencies play a critical role to play in pandemic preparedness and response. Yet, the current pandemic has exposed significant shortcomings in these agencies’ preparedness and response efforts. Using FDA’s response to COVID-19 as a case study, this article introduces the concept of “regulatory reactivity” to describe and analyze regulatory agency response to external pressures that rely on the adoption of tailored-to-the-moment measures. The article delineates the conceptual and practical differences between the application of standard agency procedures and agency response under what we term “reactive modes,” which often result in the setting-aside of agency procedures, expertise and priorities to the detriment of public health standards. We further explain how these ex post, narrowly construed modifications to the regulatory modus operandi contrast with goals of pandemic preparedness, which require ex ante, forward-looking regulatory interventions.

While we utilize COVID-19 as a lens through which to examine reactive regulatory responses to public health crises, the article anchors its analysis in broader trends displayed by the FDA in previous large-scale crises, as well as within the regulatory apparatus as a whole. We conclude with some suggestions for how the FDA might avoid slipping into reactivity mode in response to future pandemics.

Note: Posted with the permission of FDLI.

Keywords: FDA, Food and Drug Administration, COVID-19, hydroxychloroquine, convalescent COVID-19 plasma, vaccines, reactivity, administrative law

Suggested Citation

Heled, Yaniv and Santos Rutschman, Ana and Vertinsky, Liza, Regulatory Reactivity: FDA and the Response to COVID-19 (August 25, 2020). 76:2 Food and Drug Law Journal 318 (2021), Georgia State University College of Law, Legal Studies Research Paper No. 2021-24, Available at SSRN: https://ssrn.com/abstract=3680832 or http://dx.doi.org/10.2139/ssrn.3680832

Yaniv Heled

Georgia State University College of Law ( email )

85 Park Pl NE
Atlanta, GA 30303
United States
404-413-9092 (Phone)

Ana Santos Rutschman (Contact Author)

Villanova University - Charles Widger School of Law ( email )

299 N. Spring Mill Road
Villanova, PA 19085
United States

Liza Vertinsky

University of Maryland Carey School of Law ( email )

500 West Baltimore Street
Baltimore, MD 21201-1786
United States

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