Regulatory Sandboxes and the Public Health

Abstract

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 US history: the US Food and Drug Administration’s (FDA’s) Emergency Use Authorization (EUA) program for COVID-19 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 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.