Regulatory Reactivity: FDA and the Response to COVID-19

Yaniv Heled, Ana Santos Rutschman & Liza Vertinsky

ABSTRACT

The immense pressures created by the COVID-19 pandemic have exposed ingrained shortcomings in the regulatory and administrative apparatus for addressing public health crises, shortcomings that are particularly salient in the context of FDA’s emergency response. Political and public pressure, along with more subtle pressures exerted by private sector stakeholders, have combined with the sheer urgency to respond quickly to push agencies like FDA into emergency modes of decision-making that are at odds with long-held scientific and professional standards that have been the bedrock of their work.
In this Article, we provide a novel way of understanding emerging modes of decision-making at FDA in the context of highly disruptive public health crises such as COVID-19. We develop and apply the concept of “regulatory reactivity” to capture the ways in which agencies—specifically FDA—have departed from evidence-based decision-making frameworks in response to external pressures. We illustrate regulatory reactivity at work through the use of two examples drawn from FDA’s response to COVID-19: the adoption of emergency use authorizations (EUAs) and the evolution of the Coronavirus Treatment Action Plan (CTAP), an emergency program for accelerating the development of therapeutics for COVID-19. These examples illustrate how reactive modes of decision-making at FDA fail to meet both the short-term and the long-term public health mission of the agency.

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