On January 31, 2020 in the US, “[a]s a result of confirmed cases of 2019 Novel Coronavirus (2019-nCoV)”, HHS secretary Alex Azar determined “that a public health emergency (PHE) exists and has existed since January 27, 2020, nationwide”. “This U.S. public health emergency declaration follows a declaration by the World Health Organization that spread of the virus constituted a public health emergency of international concern.” [2, 3]
This declaration sets up justification for Emergency Use Authorisation (EUA) of drugs where “the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by [biological, chemical, radiological, and nuclear agents], when there are no adequate, approved and available alternatives.” [4]
In January 2017, FDA finalized the guidance to explain the FDA’s general recommendations and procedures applicable to EUA for industry and stakeholders.
- January 31, 2020 – declared public health emergency under the Public Health Service Act
- March 13, 2020 – two national emergency declarations under both the Stafford Act and the National Emergencies Act (NEA)
- March 18, 2020 – invoked emergency powers via Executive Order under the Defense Production Act
- March 19, 2020 – Trump named the Federal Emergency Management Agency (FEMA) as the lead agency in the COVID-19 emergency response efforts, a designation previously held by the Department of Health and Human Services (HHS) [5]