CDRH officials dissect early-pandemic test guidance missteps

Regulatory NewsRegulatory News | 15 February 2021 |  By 

A guidance permitting use of certain COVID-19 antibody tests had downstream negative consequences that the US Food and Drug Administration (FDA) did not envision when the document was issued nearly a year ago, including inappropriate use of the tests and an influx of tests based on falsified data or marketed with false claims.
In a New England Journal of Medicine editorial, two senior FDA officials laid out the agency’s experience with COVID-19 antibody tests, highlighting missteps and sharing lessons learned to improve practice going forward.
The director of FDA’s Center for Devices and Radiological Health (CDRH), Jeffrey Shuren, MD, JD, and Timothy Stenzel, MD, PhD, the director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, observed that a host of factors surrounding the public health emergency of the COVID-19 pandemic meant that the agency’s previous experiences with regulating in vitro diagnostics had limited applicability.
A March 2020 guidance from FDA allowed test developers to market tests without an individual emergency use authorization if the tests were validated and FDA was notified; additionally, test reports had to include FDA-specified language making clear that the tests had not been reviewed by FDA and could not be used to diagnose – or rule out – infection with COVID-19. “We put additional safeguards in place by limiting their use to laboratories certified by the Centers for Medicare and Medicaid Services to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA),” wrote Shuren and Stenzel. (RELATED: FDA Opens Path for States to Regulate COVID-19 Tests, Regulatory Focus 17 March 2020)
Previously, serology tests were not commonly used in patient care, so FDA did not foresee some of the uses to which the influx of tests would be put, wrote the regulators.
A flood of tests came on the markets as the Trump administration seized on serology tests as an aid to economic reopening, wrote Shuren and Stenzel. The administration also required insurers to provide serological tests at no cost to the consumer; tests were covered “for uses not supported by science and not in keeping with the limitations that the FDA had laid out,” noted the authors. “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.”
The situation at the end of April had 164 different developers with serology tests on the market; FDA had to notify health care providers about false claims made by developers and re-assessed its regulatory strategy. By early May, FDA began working with the National Cancer Institute (NCI) to perform independent evaluations of the tests’ validity claims. “This effort marked the first time the federal government evaluated tests itself to inform FDA authorizations,” wrote Shuren and Stenzel.
The regulators wrote that they now recognize the importance of “not permitting market entry of tests without authorization,” pointing to the March 2020 policy as a misstep that contributed to the problematic influx of test products. “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,” they wrote.
The authors also observed that FDA’s experience with serology tests is but one lesson taught by the pandemic pointing to the need for a coordinated, public-private epidemiologic research scheme to examine disease spread and immunity early in the course of disease outbreak. Education of the public and clinicians is a key part of appropriate test authorization and use during an outbreak, they wrote.
Test performance should be evaluated by the federal government or a designee prior to an outbreak, building on FDA’s experience in its collaboration with NCI. “Combined with FDA authorization, this strategy could permit rapid independent assessment of molecular diagnostic, antigen, and serology test accuracy and minimize the need for developers to find patient specimens or other clinical samples to validate their tests, thereby expediting the availability of accurate tests,” noted Shuren and Stenzel.
“Finally, all parties involved in public health emergency response need better information more quickly,” wrote the authors, calling for strengthening of national and international means of communicating critical information quickly during public health emergencies.


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Tags: CDER., coronavirus, FDA, US

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