The US Food and Drug Administration (FDA) has admitted that its policy of allowing Covid-19 antibody tests to come to market without regulatory review in the early months of the pandemic was flawed.

On 16 March 2020, the FDA published guidance that permitted developers of antibody tests to market their devices without obtaining Emergency Use Authorization (EUA), while the agency focused on evaluating 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 this was a mistake.

Following the March 2020 guidance, the FDA still needed to be notified about any device being sold, which had to be validated and state that it was not FDA-approved in its literature. By the end of April, 164 commercial manufacturers had notified the FDA of their introduction of serology tests on to the US market.

Shuren and Stenzel said: “Government officials began touting the potential usefulness of these tests for reopening the economy, and insurance coverage was provided for uses not supported by science and not in keeping with the limitations that the FDA had laid out.

“As a result, 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.”

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By GlobalData

On 17 April last year, the FDA issued a letter to healthcare providers to explain that some developers had abused the guidance to falsely claim that their tests were FDA-approved. This was followed by an outright policy change on 4 May so the agency could validate the science behind all commercially distributed tests.

As of 1 February 2021, the FDA has removed listings for 225 tests from its website, issued 15 warning letters and placed 88 firms on import alert for violations.

“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,” said Shuren and Stenzel.

The FDA has since begun to work with the National Institutes of Health, the National Cancer Institute, the Biomedical Advanced Research Development Authority and the Centers for Disease Control and Prevention to help inform its regulatory decisions regarding individual tests.

Shuren and Stenzel have now called for the federal government to prepare a research plan with private researchers to coordinate the wider study of epidemics and measures of immunity, to prepare for any future outbreaks.

They have also advocated for national and international systems for sharing pandemic research data and preventing misinformation.

“Moving forward, the FDA will continue to take steps to ensure the timely availability of accurate and reliable antibody tests to meet the public health need as the pandemic evolves,” the directors said.