FDA Emergency Use Authorization from 9/11 to COVID-19: Historical Lessons and Ethical Challenges

Abstract

Emergency use authorization (EUA) is a power granted by Congress to FDA to expedite the availability and distribution of medical countermeasures during public health emergencies. This article reviews the history of FDA’s EUA authority from its inception in the post-9/11 era to its present-day use in response to COVID-19 in order to better understand and anticipate the limitations, potential, and risks of EUAs. We offer several reflections on the history of EUAs and ethical considerations relevant to their use in connection with COVID-19 (including a potential vaccine) and future emergencies. This history and analysis center around four main themes: (i) the effects that post-9/11 counterterrorist concerns have had on FDA’s ability to deal with naturally-occurring threats to public health and safety; (ii) political interference in efforts to defend the country against those threats; (iii) the question of where the risks posed by emergency countermeasures should fall, including with respect to legal liability for vaccine-related injuries; and (iv) the key ethical and policy issues confronting FDA in public health emergencies.

Note: Funding: None to declare.

Declaration of Interests: None to declare.

Keywords: COVID-19, FDA, EUA, public health, food and drug law