The U.S. Food and Drug Administration (FDA) acknowledged that its policy of allowing Covid-19 antibody tests to appear on the market without regulatory control in the first months of the pandemic was wrong.
On March 16, 2020, the FDA issued guidelines that allowed antibody test developers to place their devices without obtaining an emergency approval (EUA), while the agency focused on assessing the flood of new diagnostic devices for active infection.
Writing in the New England Journal of Medicine, FDA directors Jeffrey Shuren and Timothy Stenzel admitted that this was a mistake.
Following the March 2020 guidelines, the FDA still had to notify any device being sold, which had to be validated and state that it was not approved by the FDA in its literature. By the end of April, 164 commercial manufacturers had notified the FDA of the introduction of serological tests on the U.S. market.
Shuren and Stenzel said: “Government officials have begun announcing the potential usefulness of these tests to reopen the economy, and insurance is provided for purposes that science does not support and does not comply with the limits set by the FDA.
“As a result, the market has been flooded with serological tests, some of which have had poor performance, and many have been marketed in a way that is contrary to FDA policy.”
On April 17 last year, the FDA issued a letter to health care providers explaining that some developers had misused the guidelines to falsely claim that their tests had been approved by the FDA. This was followed by a direct policy change on May 4 so that the agency could validate the science behind all commercially distributed tests.
As of February 1, 2021, the FDA has removed lists of 225 tests from its website, issued 15 warning letters, and put 88 companies on import warnings for violating regulations.
“Knowing what we know now, we would not allow the placing on the market of serological tests without FDA review and approval, even within the limits we originally imposed,” Shuren and Stenzel said.
The FDA has since begun working with National Institutes of Health, the National Cancer Institute, the Institute for the Development of Advanced Biomedical Research, and the Centers for Disease Control and Prevention to help make regulatory decisions regarding individual tests.
Shuren and Stenzel have now called on the federal government to prepare a research plan with private researchers to coordinate a broader study of epidemics and immunity measures, in order to prepare for all future epidemics.
They also advocated for national and international systems to share pandemic research data and prevent misinformation.
“Moving forward, the FDA will continue to take steps to ensure the timely availability of accurate and reliable antibody tests to meet public health needs as the pandemic evolves,” the directors said.