FDA's authorization process hindered COVID-19 tests in 2020: HHS report

From an unusual number of submissions of low-quality COVID-19 tests to limits at U.S. laboratories, the FDA faced multiple barriers in the early days of the COVID-19 pandemic, an HHS report found. 

The HHS' Office of Inspector General analyzed 237 developers that sought the FDA's emergency use authorization for their COVID-19 test products between Jan. 1, 2020, and May 31, 2020. As the U.S. waited for the first authorized test and public health experts scrambled to control the spread, the FDA saw "a record number of submissions — often low-quality and from developers lacking experience with FDA's process."

The agency miscalculated the efficacy of the CDC's first test, the study found, which only further delayed its response to the public health emergency. Because it had to wade through a high number of submissions for unusable products and decided to forgo clinical requirements for some test-making companies, the FDA allowed for some "problematic tests on the market."

"Furthermore, due in part to its limited engagement with the public health labs that were using CDC's test, FDA was slow to realize that testing by public health labs was far more limited than it initially expected," the HHS report said.


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