As of this writing, reports indicate there are 340 known cases of COVID-19 in the United States and 14 deaths. Worldwide, over 100,000 cases have been diagnosed with over 3500 deaths. The U.S. is in the midst of a rapidly growing public health emergency, one which HHS Secretary Alex Azar acknowledged has existed since January 27, 2020. Despite assurances from the White House and FDA that 1 million tests would be performed by March 6, 2020, a the Atlantic reports that only 1,895 tests have been performed to date. One set of problems that have been repeatedly cited is that the Federal government botched initial efforts by insisting that the CDC develop its own failed test and by prohibiting state and local laboratories from conducting their own testing.
Remarkably, in February 2019, seemingly recognizing that this exact scenario would occur, the FDA, CDC, and CMS announced the formation of the “Tri-Agency Task Force for Emergency Diagnostics” in an effort to “help facilitate rapid availability of diagnostic tests during public health emergencies.” The task force was intended to streamline inter-agency coordination and the process of obtaining clearance to perform laboratory diagnostic testing under an Emergency Use Authorization (EUA). The FDA press release proclaimed,
Time and time again, we’re reminded that disease knows no borders. While our globalized world and modern transportation help promote economic prosperity, these features also facilitate the spread of emerging infectious diseases […] In the past 15 years alone, we’ve faced serious global outbreaks of deadly pathogens. During public health emergencies, it is critical for diagnostic tests to be made available and adopted quickly into clinical and public health laboratories for rapid patient care.
The reason state and local laboratories cannot unilaterally perform their own testing during a federally designated public health emergency is because local labs risk severe penalties under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) if they conduct novel testing without an FDA Emergency Use Authorization. Notably, nearly a month elapsed from the time Secretary Azar announced a public health emergency until the time state and local laboratories were finally granted permission to perform testing. This raises the central question of why the CDC insisted on developing its own tests instead of following the vaunted EUA process described in the Tri-Agency Task Force press release.
Lack of testing is particularly acute in regions such as Florida, which has the highest proportion of citizens over 65 in the U.S.–a population particularly vulnerable to COVID-19. On March 1, 2020, Florida Governor, Ron DeSantis, declared a state of emergency, but it provided no specific mandate or direction on testing, other than stating that “persons under investigation” (PUIs) will be monitored until “the PUI tests negative.” The declaration provides no indication as to the resources devoted to testing, criteria for testing, or state, local or private entities responsible for testing.
The reasons for the failure to grant EUAs to local laboratories is particularly acute with President Donald Trump’s repeated, but incorrect insistence that the number of cases is small and patients are recovering. On February 26, the President stated there were only 15 cases and “people are getting better.” Only 12 days later, the reports of known cases in the U.S. have increased by 2266% over that figure. This is despite critical defects in testing and early detection which suggest the actual number of infected persons could be higher.