20 June 2023

In 2004, the US Congress passed an amendment to the Federal Food, Drug and Cosmetic Act known as Emergency Use Authorization (EUA). This piece of legislature legalized an anti-regulatory pathway to allow experimental medical interventions to be expedited without proper safety evaluation in the event of bioterrorist threats and national health emergencies such as pandemics. At the time, passage of the EUA amendment made sense because it was partially in response to the 2001 anthrax attacks and the US’s entry into an age of international terrorism. However, the amendment raises some serious considerations.