Regulatory uncertainty made COVID responses difficult

By William Rinehart

Published:

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Source: Center for Growth and Opportunity

The impact of CDC guidance

The coronavirus crisis began at an auspicious time on the last day of 2019, December 31, when a case of pneumonia of an unknown cause was first reported to the World Health Organization. While it is clearly the case that Chinese government officials knew about the first cases and tried to suppress reports, the virus reached the United States on January 15.

CDC test kits narrowly restricted testing

On January 10, researchers from China first released the genetic sequence of the novel coronavirus. They followed up on January 12 with further genomic sequences. According to official CDC data detailed below, the CDC was able to test for the virus on Saturday, January 18, making it one of the first countries outside of China to be able to detect the virus. That next Tuesday, January 21, CDC Director Nancy Messonnier announced the test in a telebriefing, “Right now, testing for this virus must take place at CDC, but in the coming weeks, we anticipate sharing these tests with domestic and international partners through the agency’s International Reagent Resource.”

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Source: The CDC

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Source: The CDC

The regulation of diagnostic tests and the impact of Emergency Use Authorization

Diagnostic testing is regulated through one of two paths. Tests, which are formally known as in vitro diagnostic (IVD) devices, can be developed and distributed as commercial “kits”. Or they can be developed, validated, and conducted by a single laboratory. Tests of the second type are known as laboratory-developed tests or LDTs.

  • On March 17, the FDA issued an EUA for Quest Diagnostics’ RT-PCR test, four days after the company filed paperwork.
  • Also, on March 17, the FDA issued an EUA for Quidel Corporation’s Lyra SARS-CoV-2 Assay, six days after the company filed paperwork.

Knowledge asymmetries as friction points

Knowledge gaps also plagued responses. For one, overlapping agency jurisdictions left practitioners and organizers confused. Most of the labs had been working intimately with the CDC and likely assumed that it was the source of permission for testing, but that task is overseen by the FDA. As noted earlier, Dr. Lindquist in Washington State sent the CDC leadership an email on February 10, asking for permission to test, even though it was the FDA’s approval that they needed. The six-day delay in response could have been avoided if everyone knew the lines of authority better.

Conclusion

The regulatory thicket created management difficulties for health care workers at the epicenters of the contagion. Especially for those early moments of the crisis which occurred throughout January and into February, it is important to study how institutions, hospitals, and health care workers adapted to the constraints imposed by regulation. These civil society groups were also hamstrung by their own knowledge problems. Altogether these conditions disincentivized coordination at the moment it was needed. In part, some of the confusion was unavoidable. At the same time, countries like South Korea and Singapore show that testing can be expanded quickly. Once this current crisis has passed, leaders should take the time to carefully assess emergency powers and ensure they can run smoothly when we need them most.

CGO scholars and fellows frequently comment on a variety of topics for the popular press. The views expressed therein are those of the authors and do not necessarily reflect the views of the Center for Growth and Opportunity or the views of Utah State University.