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FDA to Keep COVID-19 EUA Pipeline Open for Now

by | Mar 29, 2023 | News, Open Content

U.S. Department of Health and Human Services secretary takes action to ensure continued access to COVID-19 EUA products.

As expected, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra took action to ensure that COVID-19 products that have received FDA Emergency Use Authorization (EUA) remain valid after the public health emergency (PHE) officially ends on May 11.

On March 15, the secretary amended the declaration (issued under Section 564 of the Federal Food, Drug, and Cosmetic Act [FD&C Act]) giving the FDA authority to approve COVID-19 lab tests, personal protective equipment, medical devices, and drug and biological products so that it remains in effect until the “significant potential” for a COVID-19 PHE no longer exists. The circumstances that prompted HHS to issue the original 564 EUA declaration continue to exist, as does the potential for a future COVID-19 PHE, the secretary noted.

Bottom Line: Labs and other producers that have received EUA for COVID-19 products will, in fact, get a breathing period to either make an exit or seek full regulatory approval for their products. They’ll also get ample notice when the secretary does decide to pull the plug. To terminate an EUA declaration under the FD&C Act, the secretary must first notify the public by publishing a notice in the Federal Register. The EUA declaration would then remain in effect for a reasonable period after publication of the notice to allow for “proper dispositioning,” according to the FDA.

Meanwhile, the FDA has already begun the process of weaning producers away from EUA status. So far, six different molecular SARS-CoV-2 tests have received full premarketing approval, the most recent being the DiaSorin Simplexa COVID-19 & Flu A/B Direct assay which received 510(k) clearance on March 17. On March 8, the FDA provided its first premarketing clearance for a COVID antigen test, QuidelOrtho’s Sofia 2 SARS Antigen + FIA test.