FDA's Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests

WHY WE DID THIS STUDY

In 2019, FDA, the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare & Medicaid Services (CMS) established the Tri-Agency Task Force for Emergency Diagnostics (the task force) to enhance the effectiveness of the Federal response to emergencies that require labs to implement tests. FDA is responsible for regulating in vitro diagnostic tests for infectious diseases (hereinafter referred to as tests), including authorizing them for use, in a public health emergency. After a test is authorized, FDA, CDC, and CMS have distinct responsibilities to ensure that labs appropriately implement, or use, tests. However, multiple setbacks plagued the early testing rollout for COVID-19, which was the first emergency since the task force was established. In the context of this failure, this study focused on whether FDA's engagement with the task force helped labs appropriately implement COVID-19 tests.

HOW WE DID THIS STUDY

We focused our review on the task force's activities from its establishment in February 2019 through October 2020. We reviewed task force documents, including meeting minutes, for insight into task force activities and to determine how FDA worked with task force members to prepare for future emergencies and respond to COVID-19. We also interviewed eight FDA staff members.

WHAT WE FOUND

Prior to the COVID-19 pandemic, FDA worked with the task force to identify gaps in responses to prior emergencies (e.g., the Zika virus outbreak). The task force made two recommendations within FDA's jurisdiction: (1) require test manufacturers to include certain information with tests, and (2) require test manufacturers to provide test verification materials with tests. FDA implemented both recommendations during the COVID-19 pandemic and reported that these were helpful for labs.

Starting in January 2020, the task force pivoted to respond to the COVID-19 pandemic. FDA found the task force meetings served as opportunities to collaborate, coordinate, and communicate across member agencies. It worked with task force members on drafting written products, troubleshooting, and solving problems. FDA members found that participating in the task force fostered relationships that were beneficial both within the task force's scope and beyond it.

WHAT WE CONCLUDE

The task force experience demonstrates the importance and potential benefits of expanding interagency exchanges, including for those parts of the testing process that struggled during the pandemic. Indeed, FDA's continued coordination with the task force holds potential for further improvements in emergency test implementation in labs.