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Review of FDA COVID-19 EUA Process Finds Issues With IT, Staffing, Validation Frameworks


NEW YORK – The US Food and Drug Administration on Tuesday released a report from management and tech consulting firm Booz Allen Hamilton assessing its Emergency Use Authorization process over the course of the COVID-19 pandemic.

The contractor reviewed primary documents and conducted internal and external stakeholder interviews to complete the report, the agency said on its website.

Three key issues Booz Allen noted in its report were the FDA's unoptimized IT system, which negatively impacted precise tracking of new review metrics; difficulty quantifying and analyzing staff allocation, making it "difficult to determine" what caused shifts in staff and "how shifts were coordinated to address" the issue; and limited understanding by test developers on how to appropriately validate a test.

Booz Allen included three key recommendations for the agency to implement to improve the EUA process. For the IT issue, it recommended that the Center for Devices and Radiological Health, a subunit of the FDA, consider ways to optimize the IT system for EUA processes by fully automating submission and tracking of EUA requests.

The change would allow for a "more comprehensive picture of review time from EUA submission to decision," the report said.

CDRH said it agrees with the recommendation and has taken several steps to identify IT system needs to improve submission tracking, although it didn't provide details on those steps. It noted that in 2016, the agency started its Digital Transformation Initiative to provide better IT infrastructures, technology solutions, and data to help internal and external stakeholders across all of its regulatory programs.

Regarding the staffing concerns, Booz Allen recommended that CDRH develop a strategy and plan for allocation and tracking of staff during public health emergencies, including identifying the most likely areas for future emergencies and creating a process for cross-training to prepare staff in those areas if a public health emergency occurs.

CDRH said it is working to prepare for staffing needs in future situations by outlining a blueprint for an Emergency Response Process that will create guidelines for information sharing, staff mobilization, and operational flexibility. It is also starting an improvement effort to standardize how surge capacity is defined and managed across the agency, it said.

In addition, CDRH said it is using a "resource pool of qualified contractors" to support its activities, including EUA reviews.

Booz Allen also recommended that the Center develop a framework for how to validate diagnostic tests for emerging pathogens during a declared public health emergency.

The agency said it plans to work with test developers to establish templates for commonly anticipated pathogens that could be adapted for future outbreaks. It also plans to create a framework for "conducting appropriate validation under different circumstances," CDRH said.

It added that it plans to continue using communication strategies and tools that have worked throughout the COVID-19 pandemic, including town halls, webinars, a telephone hotline, and email boxes for inquiries and templates.

CDRH suggested that the US government work with international partners to create a plan for sharing clinical specimens as soon as a public health threat emerges and establish the capacity to independently evaluate test performance before an outbreak occurs, so independent evaluation can be performed quickly.

"Combined with FDA emergency use authorization, this strategy could permit rapid independent assessment of molecular diagnostic, antigen, and serology test accuracy and minimize the need for test developers to procure specimens for clinical validation," CDRH said.

Jeff Shuren, director of CDRH, said in a statement that the agency "will continue to take a flexible approach to COVID-19 tests to meet public health needs and increase access to testing for consumers, including at-home diagnostic tests, which remain a top priority for the agency, that is grounded in sound science."