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Emergency Use Authorization didn't exist then, Spanky

Posted on: August 2, 2021 at 14:48:05 CT

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M.O.B. Votes:

Ultimately, it was the War on Terror that would give rise to emergency use authorization. After the events of September 11, 2001 and subsequent anthrax mail attacks, Congress enacted the Project Bioshield Act of 2004. The act called for billions of dollars in appropriations for purchasing vaccines in preparation for a bioterror attack, and for stockpiling of emergency countermeasures. To be able to act rapidly in an emergency, Congress allowed FDA to authorize formally unapproved products for emergency use against a threat to public health and safety (subject to a declaration of emergency by HHS). The record indicates that Congress was focused on the threat of bioterror specifically, not on preparing for a naturally-occurring pandemic.

FDA’s newfound EUA authority would be used relatively sparingly for the first 16 years following its enactment. During that time, its most extensive use was in combating the H1N1 swine flu pandemic of 2009 by authorizing medical equipment and existing influenza drugs. Health policy experts would look back on the use of EUA against H1N1 as an overall success. It would also be used (pursuant to an amendment allowing for preemptive EUAs) to authorize occasional countermeasures in anticipation of MERS, Ebola, Zika, and other epidemics, none of which ultimately materialized in the United States.