Following the declaration of a Public Health Emergency (PHE) on January 31, 2020 by the US Secretary of Health and Human Services (HHS), Alex Azar, he then determined that circumstances existed to justify the Food & Drug Administration (FDA) emergency use authorization (EUA) of medical devices, including alternative products used as medical devices, (including biological products), pursuant to pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. The declaration was effective Febraury 4, 2020 [3, 5]

The HHS Secretary the invoked the 2005 PREP Act, the Public Readiness and Emergency Preparedness Act, back dating it effective February 4, 2020. Under this US Act pharma giants are provided total immunity from liability until 2024. [1, 2, 4, 6]

The FDA may issue an EUA ONLY after concluding that 4 statutory criteria are met:

  1. The agent referred to in the declaration [SARS-CoV-2 which causes disease COVID-19] can cause serious or life-threatening disease or condition.
  2. Evidence of effectiveness based on the totality of scientific evidence available. [5]
  3. The known potential benefits outweigh the known potential risks.
  4. There is no adequate, approved, and available alternative.