May 30, 2024

Changes to the Food and Drug Administration’s emergency use authorization process compromised COVID-19 test quality at the start of the pandemic, Health and Human Services Department inspectors found.

A report released Wednesday by the HHS Office of the Inspector General pointed to problems with test performance and said patients may have received inaccurate results. 

The report said the federal government needs to solicit input from a variety of stakeholders and overhaul its strategy ahead of the next pandemic.

“We need a coordinated federal effort to determine a federal testing strategy that goes beyond the EUA process. We’re talking beyond FDA’s responsibility alone,” said Elizabeth Sandefer, HHS Office of Inspector General’s team leader for the study, on Wednesday.

“There will be a next time, so it’s critically important that we make improvements now,” she said.

The FDA also needs communication avenues with testing labs during an emergency; test developers need more guidance on validating tests during clinical sample shortages; and the agency needs back-up plans for handling the workload emergency response entails. The FDA also should offer support to developers during the authorization process, especially when developers are less experienced, the inspectors said. 

The FDA agreed with all of the inspectors’ recommendations, the HHS report stated. 

During a public health emergency, the FDA can use emergency authorization to allow distribution and use of products for diagnosis, treatment or prevention of a serious disease. The products don’t need to have the same standard of evidence required for full approval by the FDA: Instead of demonstrating safety and effectiveness, developers only need to show reasonable belief that the product is effective, and that potential benefits outweigh potential risks. 

After issuing an emergency use authorization, the FDA continues to review products to make sure they still meet the authorization requirements. The agency can rescind an authorization if misconduct or safety concerns crop up. 

The authority has existed since 2004, but the COVID-19 pandemic saw more EUAs issued for a single threat than ever before, according to the report, which examined tests reviewed by the FDA between Jan. 1 and May 31, 2020, and oversight through Dec. 31, 2020. 

The FDA issued its first emergency authorization of a diagnostic test to the Centers for Disease Control and Prevention on Feb. 4, 2020. Just four days later, labs began to notify the FDA of problems with the CDC’s test. The next emergency authorization wasn’t issued until Feb. 29, and the first commercial emergency authorization until March 12. The federal government didn’t have a predetermined plan to fill the testing gap after issues with the CDC’s test arose, which were primarily due to contamination during manufacturing. 

Sandefer said the protocol was standard at the time.

“It may seem absurd to us in hindsight that CDC was the first and only authorized test for so long but you know, that’s actually not atypical, that’s how it typically goes, and it has worked in the past,” she said.

Throughout the winter and spring of 2020, FDA further relaxed emergency authorization requirements in an effort to ramp up testing capabilities across the country. 

The agency recommended developers use fewer patient samples in their applications and allow qualified labs to start distributing tests prior to submitting an emergency authorization request. By May 2020, 245 labs had taken advantage of the early testing policy.  

The FDA allowed serology tests, used to detect prior COVID-19 infection, to come onto the market with even looser requirements than diagnostics, and later recommended diagnostic and serology test developers substitute supplies in COVID-19 tests without applying for emergency authorization due to shortages. 

Although tests became available more quickly, relaxing emergency authorization requirements created problems, said the report. One FDA analysis of 125 authorization requests for lab-developed diagnostic tests found 82 had issues with their design or validation, according to the HHS report. Antibody tests without emergency authorizations performed so poorly that the FDA decided to require authorization requests within 10 days of a test coming to market. The FDA removed 167 serology tests from its list of tests that could remain on the market by November 2020. 

“Weeks or months may have passed before FDA reviewed the EUA request and required a developer to correct performance problems. This may have led to patients receiving false positive or false negative test results; the public health implications of the policy remain unclear,” the report added. 

The FDA also struggled to keep up with the number of emergency authorization requests for COVID-19 tests. From January through May 2020, the FDA got more than 100 requests per month, on top of the agency’s typical workload. Most authorization applications didn’t meet agency standards. 

The FDA offered guidance to developers about the emergency authorization process and tried to make it easier. Regulators provided request templates, switched to electronic submissions, held town hall meetings and updated frequently asked questions on the FDA’s website. The agency also adjusted its internal review process to manage its workload internally. Still, some developers complained of insufficient  transparency around the authorization process or with the changes the FDA made, the report said. 

Developing a suite of emergency use authorization templates for future pathogenic emergencies could help improve response to the next public health crisis, as could taking stock of current emergency authorization submission guidance and making a slew of other changes, the report suggested.

But key to moving forward will be creating a national testing strategy, HHS’ Sandefer emphasized.

The FDA should coordinate with other federal agencies like the Centers for Medicare and Medicaid Services and the National Institutes of Health to pre-certify labs for test development, and try to contract with manufacturers before another emergency hits, the report said. 

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