COVID-19 tests in 2020 have been compromised by the FDA licensing process

Department of Health and Human Services inspectors found that changes to the FDA’s emergency licensing process compromised the quality of COVID-19 testing at the start of the pandemic.

A report released Wednesday by the HHS office of the inspector general noted problems performing the test and said patients may have received inaccurate results.

The report said the federal government needs to seek input from a variety of stakeholders and reform its strategy before the next pandemic.

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

“It will be there again, so it is very important that we make improvements now,” she said.

The FDA also needs communication methods with testing laboratories during emergencies; Test developers need more guidance on validating tests during a shortage of clinical samples; The Agency needs backup plans to deal with the workload of emergency response. Inspectors said the FDA needs to provide support to developers during the licensing process, especially when developers are less experienced.

The HHS report stated that the Food and Drug Administration agreed with all of the inspectors’ recommendations.

During a public health emergency, the FDA can use the emergency authorization to allow the distribution and use of products for the diagnosis, treatment, or prevention of a serious illness. Products do not need the same standard of evidence required for full approval by the Food and Drug Administration: Instead of demonstrating safety and efficacy, developers only need to demonstrate a reasonable belief that the product is effective, and that the potential benefits outweigh the potential risks.

After the emergency use authorization is issued, the FDA continues to review products to ensure they still meet emergency authorization requirements. The agency can revoke the authorization if misconduct or safety concerns arise.

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

The Food and Drug Administration issued the first emergency authorization for a diagnostic test to the Centers for Disease Control and Prevention on February 4, 2020. Just four days later, laboratories began notifying the FDA of CDC testing problems. The next emergency permit was not issued until February 29, and the first commercial emergency permit was until March 12. The federal government did not have a predetermined plan to fill the testing gap after problems with the CDC test, which were primarily due to contamination during manufacturing.

Sandefer said the protocol was standard at the time.

“It may seem silly to us in hindsight that the CDC has been the first and only authorized test for a long time but you know, that’s actually not unusual, that’s what usually happens, and it has worked in the past,” she said.

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

The agency recommended that developers use fewer patient samples in their applications and allowed qualified laboratories to begin distributing tests before submitting an emergency permit application. By May 2020, 245 laboratories have benefited from the early testing policy.

The U.S. Food and Drug Administration allowed serology tests, used to detect previous COVID-19 infections, to enter the market with looser requirements than diagnoses, and developers of diagnostic tests and serology tests later recommended an alternative supply in COVID-19 tests without applying for emergency authorization due to shortages. .

Although tests are becoming available more quickly, the relaxation of emergency authorization requirements has created problems, the report said. One Food and Drug Administration (FDA) analysis of 125 license applications for lab-developed diagnostic tests found that 82 had design or validation issues, according to a HHS report. The performance of antibody tests without emergency permits was so poor that the Food and Drug Administration decided to seek authorization within 10 days of the test reaching the market. The Food and Drug Administration (FDA) has removed 167 serological tests from the list of tests that could remain on the market by November 2020.

“It may have been weeks or months before the FDA reviewed the EUA application and required the developer to correct performance issues. This may have resulted in patients receiving false positive or negative test results; the public health implications of this policy, the report added, still not clear.

The Food and Drug Administration has also struggled to keep up with the number of emergency use authorization requests for COVID-19 tests. From January to May 2020, the FDA received more than 100 requests per month, in addition to the agency’s usual workload. Most authorization requests do not meet agency criteria.

The Food and Drug Administration (FDA) has provided guidance to developers about the emergency authorization process and has tried to make the process easier. Organizers submitted application templates, switched to electronic submissions, held open meetings, and updated frequently asked questions on the FDA’s website. The agency has also modified the internal audit process to manage its workload internally. However, some developers felt there was not enough transparency about the authorization process or changes made by the Food and Drug Administration, the report said.

Develop a set of emergency use authorization templates For future pathogenic emergencies it could help improve the response to the next public health crisis, and guidelines for presenting authorizations in current emergencies could be evaluated and a slew of other changes made, the report suggested.

The key to moving forward, Sandifer emphasized, is creating a national testing strategy.

The report said the Food and Drug Administration should coordinate with other federal agencies like the Centers for Medicare and Medicaid Services and the National Institutes of Health to pre-certify laboratories to develop tests, and try to contract with manufacturers before other emergencies occur.

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