The US Food and Drug Administration moved too quickly to allow the marketing of antibody tests for coronavirus without authorization last spring and ended up with a lot of tests that did not work well, two top officials said Saturday.
The FDA won’t be doing that again, and agencies need to prepare ahead of time for quick development of tests in pandemics, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health and Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, wrote in a joint commentary in the New England Journal of Medicine.
"Flawed" policy: At the time it seemed important to get antibody tests onto the market so researchers could assess just how widespread the virus was, they said. So, FDA published guidance in March allowing developers to market tests without emergency use authorization as long as the test was validated, and the tests carried warnings that they were not FDA-reviewed.
“In hindsight, however, we realized that the policy outlined in our March 16 guidance was flawed,” they wrote.
By April, they wrote, “the market was flooded with serology tests, some of which performed poorly and many of which were marketed in a manner that conflicted with FDA policy.”
Later, the FDA worked with the National Cancer Institute to evaluate antibody tests developed by university labs. That worked better, they said.
“Knowing what we know now, we would not have permitted serology tests to be marketed without FDA review and authorization, even within the limits we initially imposed,” Shuren and Stenzel wrote.
Lessons learned: “First, our experience with serology tests underscores the importance of authorizing medical products independently, on the basis of sound science, and not permitting market entry of tests without authorization,” they wrote.
Plus, the federal government needs to coordinate research better, and evaluate tests before they are needed so they can be checked quickly in an emergency.