FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing

WHY WE DID THIS STUDY

At the start of the COVID-19 pandemic, no test existed to identify this novel virus. Testing is vital to diagnose infected individuals and understand spread during infectious disease emergencies. The Food and Drug Administration (FDA) used its Emergency Use Authorization (EUA) authority to facilitate the development and availability of COVID-19 tests. Members of Congress have expressed strong interest in the availability and effectiveness of both diagnostic and serology tests. This review assesses how FDA used its EUA authority to authorize COVID-19 tests during the crucial first months of the pandemic.

HOW WE DID THIS STUDY

We focused our review on the early months of the pandemic: January 1 through May 31, 2020. We relied on FDA documents, data, and interviews to determine how FDA conducted EUA activities and decision-making. We surveyed and received responses from 237 test developers that engaged with FDA about their COVID-19 tests and analyzed survey responses to assess experiences working with FDA. We also interviewed test developers and representatives from a professional laboratory association for context about developer experiences.

WHAT WE FOUND

The failure of the Centers for Disease Control and Prevention (CDC)'s first test rollout revealed vulnerabilities in the Federal approach to testing early in the COVID-19 pandemic. It is typical for CDC to be the first to receive an EUA, and FDA expected that the CDC's test would meet the early testing needs of the nation. However, CDC's first test was unusable for many for weeks while no other test was authorized. Furthermore, due in part to its limited engagement with the public health labs that were using CDC's test, FDA was slow to realize that testing by public health labs was far more limited than it initially expected. To address problems with the first authorized COVID-19 test, FDA worked with CDC, including allowing CDC to modify the terms of its original EUA. However, preventing a similar problem from occurring in future emergencies would require actions outside of FDA's authority alone.

In using its EUA authority, FDA also made calculated decisions to increase availability of COVID-19 testing, but these decisions often came at a potential cost to test quality. FDA authorized tests using lower levels of evidence to support developers struggling to access clinical samples. FDA's policies allowed diagnostic and serology tests to get on the market quickly; however, that resulted in some problematic tests on the market, requiring further action by FDA.

FDA's decision to accept all EUA requests resulted in a record number of submissions-often low-quality and from developers lacking experience with FDA's processes. In response, FDA took steps to support developers and ease its workload, which included issuing EUA guidance, updating templates (submission guides for developers requesting EUA), and adjusting its EUA review process, among others. Some developers still reported being frustrated and confused.

WHAT WE RECOMMEND

Our findings underscore the need to apply actionable insights from FDA's early experiences with the COVID-19 pandemic toward current and future infectious disease emergencies to better balance test availability and quality. We recommend that 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
• Establish formal communication channels between FDA and the lab community, to be used in emergencies that require testing
• Work with Federal partners to implement lessons learned about a national testing strategy that go beyond the EUA process

FDA concurred with all of our recommendations.