Questions Regarding the Government’s COVID-19 Response

Earlier this month, the Project On Government Oversight (POGO) published a detailed day-by-day timeline of the first 100 days of the U.S. federal government’s response to coronavirus. The timeline is intended to help those officially reviewing the response—such as a potential 9/11 Commission-like panel—with their efforts.

Although not exhaustive, the following are some important questions that arise from POGO’s timeline.

The Time It Took to Invoke the Defense Production Act

The Defense Production Act allows the federal government to direct U.S. companies to prioritize production of certain goods in emergencies. The timeline cites reporting that using the act was being discussed within the administration as early as mid-January as a way to speed production of critical medical gear and equipment that would likely be needed in a pandemic (a federal exercise in the fall of 2019 warned of such supply shortfalls). Yet the law was not used until the end of March.

• Why did it take over two months for the administration to use the Defense Production Act? Some reporting states that the Chamber of Commerce and companies lobbied the administration against using the law. Did industry lobbying play a role in the delay?
• If the law had been used one or two months or even weeks earlier, could N95 masks (which filter out tiny virus particles), ventilators (which help people with respiratory diseases breathe), swabs for coronavirus tests, and other gear have been produced earlier in larger quantities? If so, is it plausible that shoring up the supply chain earlier could have saved lives and sped up other parts of the government’s response, such as making it easier toramp up testing?

The Implications of the Lag in Detecting the First U.S. Cases

On January 20, a top Chinese scientist confirmed that the virus could spread from person to person. The U.S. government confirmed the first case in the U.S. on January 21, six days after the infected person had returned from China. The U.S. confirmed its second case on January 24, nearly a week and a half after that person returned to the U.S. France announced Europe’s first known case that same day, and Thailand and Japan had identified cases even earlier. On January 28, a top Centers for Disease Control and Prevention (CDC) official said “there have been isolated reports of asymptomatic infection from several countries … we’re looking at that data closely … we would have to change our operations if indeed that was a significant issue.” Tightened restrictions for travelers from China went in effect on February 2, but European travel restrictions did not go into effect until mid-March.

• In late January, were government officials concerned about the lag between the arrivals of infected travelers and the confirmation of their infections? Did any government experts suspect in late January and early February that the virus could have spread undetected in the U.S. in the period before those travelers tested positive for coronavirus? (One researcher estimated that, as of March 1, at least 150 people were infected by the coronavirus stemming from the first confirmed case in the U.S.)
• Were experts concerned about travelers who came from China prior to the implementation of travel restrictions on February 2? (On an average day in fiscal year 2019, more than 14,000 travelers arrived in the U.S. from China.)
• In late January and in February, were government experts raising concerns about cases arriving from countries other than China? Was anyone in the government pushing for a much broader array of screening for all international passengers arriving at U.S. airports during this period?
• Was there any push during this time period by government experts to broaden CDC testing criteria in the U.S. given that there were some early reports that it could be spread by people who were not showing symptoms?
  

Understanding the Timing of the FDA’s Policy Shift Regarding Testing

Very few tests per day occurred in January and February. The test kits the CDC had shipped out to select state public health laboratories were found to have flaws, which were detected at least as early as February 8 and publicly announced on February 12. While the CDC took weeks to address the flawed test, labs around the nation were not allowed to administer coronavirus tests they had developed, which had not been approved by the Food and Drug Administration (FDA).

On February 29, the FDA issued a new policy that allowed certain regulated laboratories to administer their own tests for coronavirus even before the FDA had granted emergency use authorizations for them. The FDA press release said the aim of the new policy was “to achieve more rapid testing capacity in the U.S.” This came five days after the head of Texas’s public health labs and the head of the Association of Public Health Laboratories had written to the FDA commissioner urging him to use “enforcement discretion” to allow state public health labs to use tests that they had developed without emergency use authorizations. The FDA’s new policy came a month after Secretary of Health and Human Services Alex Azar reportedly warned President Trump that coronavirus could become a pandemic. (The FDA and CDC both report to Azar.) The shift in FDA policy occurred 21 days after problems with the CDC test were detected and 25 days after two former Trump officials, including a former FDA commissioner, published a Wall Street Journalop-ed recommending that the CDC help major hospital labs conduct tests because companies developing tests need FDA approval and that “will take some time.”

• Why did it take so long for the FDA to issue a policy allowing certain laboratories to use their own test without receiving an emergency use authorization? Were there any legal or other roadblocks to the new policy?
• How many laboratories could have begun testing before the shift in FDA policy at the end of February? How early could these laboratories have begun testing for coronavirus?
• Could greatly expanded testing in early-to-mid February have plausibly averted the widespread circulation of coronavirus in the U.S.? Could it have helped identify Europe as a major importation source of the virus and led to earlier travel restrictions and better screenings at airports weeks earlier? Could widespread lockdowns have been potentially avoided even if more targeted lockdowns in some cities might have still occurred, perhaps earlier?
• To what extent was the FDA’s position in early 2020—before its February 29 policy was issued—a deviation from the past? What was the role of the CDC in the FDA’s decision-making? There is reason to believe the FDA—with input from the CDC—has been less restrictive of lab-developed tests during past emergencies. A 2011 report by the Association of Public Health Laboratories on the 2009 H1N1 response states, “When the FDA was considering putting H1N1 tests [that had not been granted emergency use authorizations yet] under more control and scrutiny, the [CDC] task force picked up the phone again” to tell FDA to hold off. The report also states that “as H1N1 shows, public health labs’ ‘home brews’”—a reference to laboratory-developed tests that may or may not have been granted emergency use authorizations by the FDA—"can be critical in a crisis.”

More information will likely come to light. For instance, since POGO published the timeline, a prominent high-level whistleblower from within the Department of Health and Human Services filed an official complaint and made public numerous government emails from the first 100 days. And the Congressional Research Service has issued a report with details on the information China was revealing about the coronavirus in the first weeks of the outbreak.

A critical assessment of successes and failures can be a difficult and sometimes unpleasant exercise. But if Congress and the executive branch don’t commit to learning lessons from what the government got right and wrong during the COVID-19 pandemic, public health and the economy will suffer unnecessarily during the next public health crisis.