FDA Now Lacks Authority to Halt Use of Inaccurate Coronavirus Tests

Published Sep 22, 2020

What happened: In a move strongly opposed by Food and Drug Administration (FDA) officials, the agency will no longer use science-based checks to regulate a broad swathe of laboratory tests, including coronavirus tests. The new policy, which was announced immediately and without guidance, would remove science-based checks the FDA relies on to ensure the quality and accuracy of laboratory-developed tests for a wide range of diseases. Experts fear that this could flood the market with inaccurate coronavirus tests.

Why it matters: If laboratory tests for the novel coronavirus diminish in accuracy and quality due to a sidelining of science, then COVID-19 case data from across the country has the real possibility of becoming less robust and even flawed. Policymakers rely on COVID-19 case data to make major decisions during the pandemic, such as whether to open or close schools, businesses, and other institutions. Less accurate COVID-19 data could lead to policy actions that further spreads the virus, puts people in hospitals, and increases the death rate.

According to a new policy from late August, the Food and Drug Administration (FDA) will no longer carry out science-based checks on laboratory tests before they hit the market, which has the real possibility of flooding the market with inaccurate and less reliable novel coronavirus laboratory tests. Laboratory-developed tests have been widely used across the country to detect the presence of the novel coronavirus in a person and the results of the tests feed into official county, state, and federal counts on COVID-19 case data. The public announcement consisted of a single paragraph on the Department of Health and Human Services (HHS) webpage. It allows clinics, academic institutions, and commercial labs to develop their own laboratory tests for various diseases without a scientific check from experts at the FDA.

FDA officials have been worrying for months about this very scenario and are deeply disturbed that this policy has been enacted. Even a month after the policy was announced, top FDA officials are still so disturbed that they haven’t publicly announced the change on the FDA’s website and have refused to talk about it on calls with agency stakeholders. According to several current and former administration officials, HHS Secretary Alex Azar was the main force behind this decision and it led to screaming matches with FDA chief Stephen Hahn, who was vigorously opposed this change.

The tests in question, called “laboratory-developed tests,” are tests that are developed and validated by a single laboratory. These tests are generally not distributed or sold to any other labs or health care facilities, although some work with mail-in samples. Laboratory-developed tests are used for a variety of diseases, such as cancer, Alzheimer’s disease, and genetic conditions, and can be used to assess a variety of important medical questions such as whether cancer patients are responsive to certain drugs. These tests have played a vital role during the pandemic in detecting whether clinical specimens submitted by individuals tested positive or negative for the presence of the novel coronavirus.

Back in February, HHS’ overreliance on a faulty novel coronavirus test developed by the CDC, in addition to the FDA’s decision to not clear any laboratories from developing and conducting their own test until February 29, led to the infamous testing crisis that greatly hampered the US’ early response to the pandemic. Since February 29, the FDA has tried to balance the difficulties posed by granting fast approvals of novel coronavirus laboratory tests with a check on whether these tests are accurate by utilizing a mechanism called an emergency use authorization.

Emergency use authorization has expedited access to diagnostic tests while also checking them for accuracy; this has allowed molecular diagnostic novel coronavirus tests to be developed, validated, and deployed within weeks rather than several months to over a year. This oversight process has proven to be vital for checking the validity of novel coronavirus tests. According to a peer-reviewed article from September, out of 125 laboratories applying to the FDA for an emergency use authorization for a novel coronavirus test, 82 tests were identified as having design or validation problems. As a result of this oversight, the FDA stopped many of these non-accurate tests from being used by laboratories. The FDA also worked with the large majority of laboratories that had design flaws to correct their validity and quality issues; this led the laboratories to develop more accurate coronavirus tests that were then approved by the agency.

The HHS policy removed this emergency use authorization check by the FDA for coronavirus tests, among other diseases. This breaks with established precedent during prior epidemics. The FDA previously used these same procedures to provide oversight of laboratory-developed tests developed during the H1N1 pandemic in 2009 and the Zika outbreak in 2015 and 2016.

But more problematically, this policy action will increase the number of novel coronavirus laboratory tests that lack accuracy, quality, and validity. Low accuracy tests can place the lives of individuals and their loved ones at risk – for instance, those who falsely believe they are negative for the novel coronavirus could end up spreading the virus to their social networks. It also diminishes our ability to understand where outbreaks are occurring and how to respond to the pandemic. As a nation, we are deeply dependent on having accurate COVID-19 case data in order to make evidence-based decisions. Through this action, an important science-based check has been sidelined right when we need robust data the most, to protect people’s health and safety during a pandemic.