Management Expert Report Cites Weaknesses in Agency’s EUA Processes

From almost the moment the COVID-19 public health emergency was declared, the US Food and Drug Administration (FDA) has come under fire for not making better use of its emergency use authorization (EUA) powers to enable desperately needed SARS-CoV-2 diagnostic tests to market more rapidly. A new report from an outside management consulting firm hired to review the agency’s handling of the COVID-19 situation cites key weaknesses in the current EUA process and offers recommendations for remedying them.

The EUA Process

Section 564 of the Federal Food, Drug, and Cosmetic Act gives) gives the FDA the authority to authorize commercially developed new diagnostic tests on an expedited basis during declared public health emergencies. The EUA process allows for the development, validation, authorization and deployment of new tests in a matter of weeks, rather than months or years. COVID-19 is the sixth public health emergency in which the agency has drawn on its EUA powers. To date, the FDA has granted EUA for approximately 400 tests and home collection kits and over 1,700 medical devices designed for diagnosing, treating or preventing COVID-19.

The 3 Problems with the EUA Process

While those numbers sound impressive, they only tell a part of the story. The report, which was created by the well know management and tech consulting firm Booz Allen Hamilton based on internal review and interviews with stakeholders, cites three key issues affecting the effectiveness of the EUA process during the COVID-19 emergency:

• The agency’s unoptimized IT system, which negatively impacted precise tracking of new review metrics;
• Difficulties in quantifying and analyzing staff allocation, which interfered with the agency’s ability to determine the causes of shifts in staff and how to coordinate shifts to address the issue; and
• Test developers’ limited understanding on how to appropriately validate a test.

The 3 Recommendations

The Booz Allen report includes recommendations of the measures the agency can take to fix each of these problems and improve the EUA process:

1. 1. Automatize EUA Submissions Process: To address the IT issues, the report recommends that the FDA’s Center for Devices and Radiological Health (CDRH) explore methods of optimizing the IT system for EUA processes by fully automatic submission and tracking of EUA requests to enable a “more comprehensive picture of review time from EUA submission to decision.” CDRH says it agrees with the recommendation and has taken steps to determine what the IT system needs to allow for improved tracking of submissions.
   2. Create Emergency Staffing Plan: To fix the staffing problems, Booz Allen says that CDRH should develop a strategic plan for allocating and tracking staff during public health emergencies. Such a plan should identify the most likely areas for future emergencies and establish a process for cross-training to prepare staff in each of those areas to ensure that they are prepared if an actual public health emergency occurs. Again, CDRH indicated that it agrees with the recommendation and is working to create an Emergency Response Process establishing protocols for information sharing, staff mobilization and operational flexibility. It also said that it is using a “resource pool of qualified contractors” to support EUA review and other operations.
   3. Develop Framework for Validating Tests: To overcome the validation challenges, the report calls on CDRH to develop a new framework for validating tests for emerging pathogens during a public health emergency. The agency said it plans to take that recommendation and work with test developers to establish validation templates for pathogens that can be adapted for future emergencies and different situations.

Here are some of the key new FDA EUAs and clearances announced in October 2021:

New FDA Emergency Use Authorizations (EUAs) & Approvals