- The FDA is tightening some of its lax rules regarding approval of coronavirus testing supplies after initially loosening its regulations back in March.
- Companies will now need to provide proof that their tests work as intended before being rushed to market.
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In the rush to combat the novel coronavirus pandemic, many rules and regulations that were in place have been lifted in the hopes of expediting the approvals of supplies for testing and treating patients. Unfortunately, some have taken advantage of this new “wild west” way of doing things and have pushed products through the FDA’s lax approval process that might not even work.
Now, after coming under increasing scrutiny from lawmakers and healthcare professionals, the FDA has announced that it will require that companies submitting coronavirus testing supplies will have to provide proof that their products work before they can bring them to market. Yeah, this seems like a no-brainer but it wasn’t the case as recently as earlier this week.
In a lengthy statement announcing the policy change, the FDA defends its decision to open the flood gates and allow more products through than would typically have been possible.
“At the time we issued our March 16 policy, a higher level of flexibility was appropriate for antibody tests than for molecular tests that detect the presence of the virus that causes COVID-19, since antibody tests are not meant for use to diagnose active SARS-CoV-2 infection,” the statement reads. “The flexibility in our March 16 policy allowed for early use of antibody tests to begin to answer critical population-level questions about the prevalence of COVID-19 infections in different communities, and whether the presence of antibodies conveys immunity, and, if so, for how long.”
Unfortunately, the accuracy of some of the tests has come under scrutiny. Now, with more data becoming available to show which tests are working and which ones may need some additional tweaking, the FDA is tightening things down. The agency’s new “revised policy” includes the following new rules:
Under this revised policy, the FDA has outlined the following expectations for antibody test developers:
Commercial manufacturers will submit EUA requests, with their validation data, within 10 business days from the date they notified the FDA of their validation testing OR from the date of this policy, whichever is later.
Furthermore, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
These are obviously very good policies to have in place, especially as we begin to learn more about the virus and the disease it causes. If we hope to win the long-term battle against COVID-19 we’ll need to know what happens to our bodies after the illness has been beaten, how long recovery truly takes, and how likely we are to be infected again once we’ve already had it.
