CAP leaders met with the Food and Drug Administration (FDA) to discuss issues pathologists have encountered with the emergency use authorization (EUA) process during the COVID-19 pandemic, especially as it relates to some laboratories reporting delays in obtaining EUAs for SARS-CoV-2 laboratory-developed tests (LDTs). With the monkeypox virus outbreak creating a potential need for increased LDTs, the CAP relayed concerns from its members about the lengthy approval time for EUAs.

CAP President Emily E. Volk, MD, FCAP and Council of Government and Professional Affairs Chair Jonathan L. Myles, MD, FCAP met with FDA staff on September 19 to discuss pathologists’ concerns with the FDA’s EUA process, including delays, burden on laboratories, and costs. Dr. Volk and Dr. Myles specifically requested input from the FDA on how they plan to address delays, as new submissions can take up to a year for review; how to increase and improve communication with laboratories; the regulatory process for COVID-19 LDTs when the EUA process is rescinded (eg, 510k submission); and, how the CAP can engage with the FDA on solutions.

The FDA has noted several reasons leading to issues with the EUA process during the COVID-19 pandemic. These include a large number of submissions at the onset of the pandemic. The FDA has responded by engaging a third party to speed review and despite delays, the agency has allowed laboratories to offer SARS-CoV-2 laboratory tests to patients even if FDA reviews of their submissions are pending.

HHS Inspector General Issues Report on FDA EUA Process

On September 21, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published findings of a review of the FDA’s EUA process entitled “FDA Repeatedly Adapted Emergency Use Authorization Policies to Address the Need for COVID-19 Testing.” The OIG interviewed the FDA and surveyed test developers to complete the report. Early on in the pandemic, the FDA had worked with more than 400 test developers through its pre-EUA and EUA processes and issued 117 EUAs for tests by late May 2020, according to the report. As of May 2022, the FDA issued EUAs for over 400 tests including 348 diagnostic and 85 serology tests.

The report found the FDA made “calculated decisions to increase the availability of COVID-19 testing, but these decisions often came at a potential cost to test quality.” An FDA analysis of 125 EUA requests for LDTs found 82 tests had design or validation problems and the agency cited similar issues with commercial tests.

To address this and other policy issues, the HHS OIG recommended that the FDA:

• Assess and, as appropriate, revise guidance for test EUA submissions
• Develop a suite of EUA templates for future emergencies involving novel pathogens
• Expand the FDA Center for Devices and Radiological Health’s existing device-tracking platform to facilitate EUA submission and monitoring
• Expand and improve resources for test developers on the EUA process (Note: the FDA has issued EUA guidance for monkeypox testing).
• Establish formal communication channels between FDA and the laboratory community, to be used in emergencies that require testing (Note: the report cites the memorandum of understanding the CAP signed with the FDA, Centers for Disease Control and Prevention, and organizations like American Clinical Laboratory Association).
• Work with federal partners to implement lessons learned about a national testing strategy that go beyond the EUA process

The FDA concurred with the OIG’s recommendations and noted it has put several into current practice.