Did the Emergency Use Authorization Approval Process for COVID-19 Testing Under the Food, Drug & Cosmetic Act Adequately Address the Pandemic During the 1st Quarter of 2020?

Abstract

The SARS-CoV-2/COVID-19 pandemic has led to 4.55 million deaths worldwide and 219 million cases. The USA has approximately 673,000 total fatalities and approximately 42 million total cases with 165,000 cases per day. In the first quarter of the year in 2020 which was the beginning stages of the pandemic, the uncertainty regarding testing and diagnosis of COVID-19 was disorganized and confusing. The use of the Emergency Use Act ("EUA") allowed immediate access to testing with the use of the only CDC-approved real-time polymerase chain reaction nasopharyngeal ("RT-PCR") testing for COVID 19. At the end of the 1st quarter in 2020 less than 50 organizations had EUA approval for COVID 19 testing and there were approximately 936 deaths and 503 cases in the USA with 3299 deaths worldwide and 2882 daily new cases. To date, there are over 600,000 deaths in the USA. The inadequate use of private Clinical Laboratory Improvement Amendments ("CLIA") certified state and government lab testing centers in the 1st quarter of the pandemic in 2020 led to the following: inability to test and collect data, inability to identify and treat COVID positive patients, extreme unmanageable number of hospitalizations nationwide with countless deaths. The inability to meet the supply and demand led to the following deficiencies: inadequate testing, supplies with ventilators, PPE, staffing, poorly regulated hospitals, lack of statesmanship and governing of states, inadequate treatment of ill and underserved patients, testing patients without informed consent, inability to retrieve and report test results ultimately producing a quarantine with global economic disaster. The ability of the Federal Government to enact statutes such as the Food, Drug & Cosmetic Act ("FD&C") and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 ("PAHPRA") amendment within the pharmaceutical healthcare sector to protect the public is paramount for our medical and financial survival. The lack of executive leadership and anticipation of a public health emergency ("PHE") on all levels of government led to a quagmire. The COVID 19 pandemic has revealed serious issues and deficiencies in how the USA diagnoses, treats and evaluates patients. The first quarter of 2020 revealed that we were not prepared for a Global Pandemic and as a result, there were catastrophic fatalities. The current policy analysis details the complexity in obtaining an EUA, and the detailed policy required to address this issue. The detailed recommendations included in this policy analysis are a starting point to produce an in-depth evaluation of Emergency Preparedness which may assist in the treatment of the next pandemic.