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The FDA Botched Covid Testing in 2020. Nothing Has Changed Since Then.

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Tags Bureaucracy and RegulationHealth


Ah, the covid-19 test results—much maligned by some and worshipped by others! As part of the ongoing covid-19 pandemic, the results of covid-19 tests are repeatedly blasted at us from many places, often with analysis. It is easy to understand why this is the case. News media and information outlets of all types can present the absolute numbers of positive tests and data trends, which are easy to find, and many viewers can seemingly grasp what’s happening and where. And people are concerned about the spread of a novel virus and what it might do to them, their families, and their communities. In short, this is information that people demand. As such, they will get it.

It’s important to understand the basics of the two main types of tests being used to detect the virus. First, a PCR test is used to amplify and detect the presence of a DNA segment that is highly specific to covid-19. Second, an antibody test is used to detect the presence of an antigen (often a specific protein) that is present on the outside of a pathogen like covid-19. Both of these tests take biological processes and manipulate them to detect the presence of something specific—in these cases, markers of covid-19. There’s nothing magical or sacred about what’s happening. Anyone with the supplies and proper training can run these tests and report findings. And, like with any analytical procedure, there are restrictions on what can be detected. False positives and false negatives are possible, detection levels have limits, and sampling technique affects the results. All of these can be examined to better define the accuracy of the results.

And, yet, as concerns about covid-19 were rapidly increasing, many people were without this vital information that they wanted. Why was this? In the US, the Food and Drug Administration has authority over all medical testing, and in times of emergency, what is known as emergency authorized use, or EUA, can be granted so that labs around the country can begin testing. However, due to bureaucracy and red tape, the FDA took weeks, rather than days, to grant EUAs (another way of saying that it was slow to give up a little authority) so that testing could begin. It was even reported that the FDA and state authorities instructed one lab to halt their plans of repurposing existing tests for covid-19 testing. (By the way, history is already being rewritten, so it seems.) Some labs reported being ready to give results, with validated testing protocols in hand, but being forced to wait due to the FDA’s slow response time. Thus, critical time was lost; people were flying blind for weeks as fear increased.

The purpose of the EUA process, and FDA oversight, is clear enough—to weed out poorly performing test providers. But there are big problems here: First, this assumes that FDA employees are experts at everything they are regulating, which cannot be the case. Second, if the oversight is faulty or results in unnecessary delays (as was the case with covid-19 testing), nothing happens. The FDA still has the same authority now that it had in 2019. Third, oversight with lab testing is largely meaningless without having regulators (assuming they understand the scientific basis for what’s being done) observing what’s happening in the lab. Reviewing documents or protocols is largely ceremonial if the “experts” don’t have a clear understanding of the procedures and, more importantly, if they are not in the labs with the technicians performing the tests. Who knows if the tests are being administered properly, or if, following employee turnover, a new staff member is poorly trained and improperly gives the tests? This last scenario cannot ever be tracked and controlled by regulators.

These regulatory challenges would have been much better addressed with private sector testing facilities competing for customers. In order for a testing lab to be chosen by eager customers, its results have to be meaningful—those that do not provide this will not be in business for long. 

In addition, a private testing system would have allowed quicker data sharing sooner (and the use of various platforms) and for testing to be conducted in a way that pleases customers. In some areas, the reporting would have been different, but ultimately it would have had to satisfy customers. And with something like a global pandemic, broader sharing of information would likely have been welcomed at first and might have changed later—the market could have decided over time. Competing evidence would even have served as an important quality control.

It’s a good bet that an approach like the one outlined here would have mediated the effects of the covid-19 pandemic. There’s no question (with the benefit of hindsight) that covid-19, and the response to it, was going to cause difficulty and suffering for many people. Lives have been lost, businesses and services derailed, and trust eroded. But, with the right information in hand, decision-making would have been improved. Trouble areas and practices could have been avoided. Personal risk could have been assessed more accurately. We could have understood what was happening sooner and worked to get through the covid-19 pandemic more quickly. Instead, we’re left with the same stagnant, bloated system that’s slow to respond—troubling because other pathogens are sure to arise in the future. We can’t afford to stumble in the darkness again.


Contact Dave Albin

Dave Albin conducts process development research and provides technical support for a food equipment manufacturer in Iowa.

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