How did the United States fall so far behind peer nations in terms of its COVID-19 testing capacity? The most recent figures put the United States at 313.6 tests administered per million people, which pales in comparison to the testing done in South Korea (6,148 per million), Australia (4,473.4 per million), and a slew of other nations that have no business outperforming the United States on public-health metrics, such as Iran (957.1 per million).
The importance of testing is obvious from a medical standpoint — doctors want to know whether a given patient has the virus, as do the patients themselves — but testing kits will potentially allow the parts of the country to resume economic activity if made widely available. The trace-test-treat approach to the disease has allowed South Korea, for instance, to largely resume economic activity after imposing strict quarantine protocols on those infected by COVID-19, and their associates.
At The Dispatch, Alec Stapp produced an extensive timeline of the FDA’s response to the Wuhan virus, highlighting how the agency’s unwillingness to dispense of peacetime protocols may have retarded the production of testing kits. Stapp writes:
Under ordinary circumstances, the cost of using an imperfect diagnostic test often outweighs the benefit. But when public health officials need to contain a novel and highly contagious disease, speed matters more than perfection. The lessons from this debacle are clear: The FDA needs to have plans in place prior to a pandemic for public labs and private companies to produce their own test kits. A distributed strategy would be much more resilient to errors, in contrast to the single point of failure created by the FDA in this crisis.
How did the U.S. government only manage to produce a fraction as many testing kits as its peer countries? There have been three major regulatory barriers so far to scaling up testing by public labs and private companies: 1) obtaining an Emergency Use Authorization (EUA); 2) being certified to perform high-complexity testing consistent with requirements under Clinical Laboratory Improvement Amendments (CLIA); and 3) complying with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Common Rule related to the protection of human research subjects. [On] the demand side, narrow restrictions on who qualified for testing prevented the U.S. from adequately using what capacity it did have.
Stapp then goes on to describe the FDA’s internal foot-dragging and other bureaucratic hijinks that derailed the production of testing kits. He rightly notes that this foot-dragging and bureaucratic morass serves an important purpose during peacetime — when it is more important for a test to produce reliable results than it is for said test to be available quickly — but, in Stapp’s words, “when public health officials need to contain a novel and highly contagious disease, speed matters more than perfection.” Certainly accuracy is crucial during an unexpected outbreak like COVID-19 — we would not want false positives unnecessarily quarantined, nor would we would false negatives infecting public spaces — but when a balance needs to be struck between speed and accuracy, the dearth of available tests in the United States at the moment makes it seem as though the former concern was not given adequate consideration by the FDA.