Regulatory Sandboxes and the Public Health

Recently, administrative agencies around the world have engaged in a grand experiment to regulate new technologies: regulatory sandboxes. Regulatory sandboxes allow developers, in cooperation with an agency, to conduct limited tests of new technologies in real-world settings for the purpose of generating and sharing information about them. Thus far, however, “regulatory sandboxes”—as named—appear almost exclusively in the context of financial technologies, or FinTech. Whether regulatory sandboxes, in fact, exist elsewhere in administrative law would be a significant finding for both regulators and scholars; it would blunt criticisms that agencies are slow to respond to new technologies, provide regulators with an additional tool for governing new technologies, and suggest that lessons learned from current regulatory sandboxes are applicable elsewhere.

This Article is the first to explore this broader view of regulatory sandboxes and develop a synoptic theory of them. To do so, it uses one of the most radical programs to introduce new technologies in U.S. history: the U.S. Food and Drug Administration’s (“FDA”)’s Emergency Use Authorization (“EUA”) program for COVID19 treatments and vaccines. EUAs—like regulatory sandboxes but in stark contrast to typical FDA approval processes—focus on real-world deployment as a means for information gathering. EUAs are also technologically flexible and crafted with close input from the developer, among other features. Generalizing FDA’s experience with EUAs also provides lessons about the intersection of regulatory sandboxes with public trust in the agency, political interference, and the maintenance of regulatory standards. At the same time, FDA’s COVID-19 EUAs are exceptional in two senses: they touch upon the public health, widely considered to be exceptional subject matter in administrative law; and arose in the context of an unprecedented global pandemic. Nonetheless, FDA’s experience with EUAs suggest regulatory sandboxes may be an underexplored and undertheorized feature of administrative governance of new technologies. Future work in the area should assess whether regulatory sandboxes exist under the rubric identified here, which technologies they regulate, and how those sandboxes operate.

a. Professor of Law, University of Illinois College of Law; Affiliate, Carl. R. Woese Institute for Genomic Biology at the University of Illinois at Urbana-Champaign; Permanent Visiting Professor, Center for Advanced Study in Biomedical Innovation Law, University of Copenhagen, Faculty of Law. My most grateful thanks to Hilary J. Allen, I. Glenn Cohen, Nathan Cortez, Daniel J. Gervais, E. Richard Gold, Lewis A. Grossman, Matthew Herder, Dmitry Karshtedt, and Ana Santos Rutschman for their thoughtful comments and criticisms on this article, and especially to Lisa Larrimore Ouellette, W. Nicholson Price, II, and Rachel E. Sachs for their insights on this piece and their continued work and support as co-authors on our series of posts on COVID 19 innovation policy at Written Description. Thanks, as well, to my colleagues at the University of Illinois College of Law for their thoughtful contributions and suggestions. And thanks, as always, to Amanda, Lilah, Cal, and Zora for their continual willingness to experiment.

The full text of this Article is available to download as a PDF.