What Happens to COVID-19 Tests after the EUA Pipeline Closes Down?

There’s no doubt that the COVID-19 public health emergency (PHE) has been a financial windfall for the lab industry.¹ But now that the unprecedented demand for COVID-19 testing and accompanying revenues have dried up, test makers face an uncertain future. Although the FDA has already signaled in a Jan. 31 notice that manufacturers, healthcare facilities, and providers will get time to transition after the PHE ends on May 11, companies in the COVID-19 diagnostic products market are now facing a strategic decision: wind down their EUA-based investments or stick around for the long haul.²

The End of the COVID-19 EUA Era

On January 27, 2020, then U.S. Department of Health and Human Services (HHS) Secretary Alex Azar activated his emergency powers under Section 319 of the Public Health Service Act (PHS Act) by declaring a PHE for COVID-19.^3,4 That declaration, in turn, cleared the way for HHS to draw on its powers under Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act to authorize the FDA to clear products in response to the COVID-19 PHE on an Emergency Use Authorization (EUA) basis.⁵

The FDA has drawn extensively on that authority by clearing nearly 450 COVID-19 lab tests and collection devices since the so-called HHS EUA declarations took effect on February 4, 2020. These products have generated historic profits for Abbott, Becton Dickinson, Labcorp, Danaher, Illumina, PerkinElmer, Quest Diagnostics, Qiagen, Roche, and Thermo Fisher Scientific. But now that the Biden administration has announced its intention to let the COVID-19 PHE end on May 11, and with the mpox PHE already ended Jan. 31, the FDA is shutting down the EUA pipeline.^6,7

During the agency’s Feb. 15 virtual town hall meeting for COVID-19 and mpox test developers, director of the FDA’s Office of In-Vitro Diagnostics Timothy Stenzel stated that the agency plans to wrap up reviews of tests that have already been submitted for authorization while anticipating only a small number of additional submissions after that.⁸ And that will be the end of new EUAs for COVID-19 and mpox tests.

What Happens to Current COVID-19 EUA Tests?

As suggested above, the hundreds of COVID-19 products that have already received EUA clearance won’t have to come off the market when the PHE ends on May 11. The technical reason for that is that EUA declarations issued by the HHS Secretary under Section 564 of the FD&C Act can remain in effect even after the PHE for which those products were cleared expires. EUA for such products doesn’t terminate unless and until the HHS Secretary formally terminates the EUA declarations under which they were issued.

In its Jan. 31 notice, the FDA offered reassurance that this won’t happen with the COVID-19 EUA declarations right away. “FDA recognizes that it will take time for manufacturers, health care facilities, providers, patients, and other stakeholders to transition away from EUA products and the policies that support them,” the agency notes, promising to furnish support during the transition.²

In addition, test makers will get plenty of advance notice if and when the COVID-19 EUA declarations do come to an end. Under the FD&C Act, to terminate an EUA declaration, the HHS Secretary must publish a notice in the Federal Register to notify the public. That publication then triggers a transition which must last for a reasonable period to allow for “proper dispositioning.”

“For EUAs covering unapproved uses of approved products, the transition will allow a sufficient period for proper dispositioning of any labeling or other materials associated with the authorization,” according to the FDA notice.⁹ In this case, the period will likely be 180 days. In addition, authorization of an unapproved product remains effective after the EUA declaration terminates to allow for continued use with a current patient if their doctor considers it necessary.

The Future of COVID-19 Lab Tests

Even when it does happen, termination of EUA clearance won’t spell the end of all COVID-19 diagnostic products. Test makers that want to remain in the market have the option of seeking premarket clearance for their products through the usual FDA 510(k) and/or De Novo pathways, the FDA adds in its Jan. 31 notice.

In fact, the FDA has been encouraging full premarket clearance for COVID-19 EUA products almost from the beginning. But so far, at least, there have been few takers. The most notable exception is BioMérieux subsidiary BioFire Diagnostics, which has secured three of the five premarket clearances issued for COVID-19 products so far, including the first De Novo and, recently, the first CLIA waiver for a coronavirus test. Here’s the complete but short chronicle:

• March 2021: De Novo clearance for BioFire Diagnostics’ BioFire FilmArray Respiratory Panel (RP) 2.1
• Jan. 2022: 510(k) clearance for BioFire Defense’s COVID-19 Test 2
• Sept. 2022: 510(k) clearance for DiaSorin’s Simplexa COVID-19 Direct Kit COVID-19 PCR assay
• Oct. 2022: 510(k) clearance for Roche’s Cobas SARS-CoV-2 Qualitative PCR test
• Feb. 2023: 510(k) clearance and CLIA waiver for BioFire Diagnostics’ BioFire Spotfire System and Spotfire Respiratory (Spotfire R) Panel.

References:

1. https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx
2. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends
3. https://www.congress.gov/109/plaws/publ417/PLAW-109publ417.htm
4. https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx
5. https://www.congress.gov/115/plaws/publ92/PLAW-115publ92.htm
6. https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf
7. https://www.hhs.gov/about/news/2022/12/02/statement-from-hhs-secretary-becerra-on-mpox.html
8. https://www.fda.gov/media/165573/download
9. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-approved-mcms

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Here are some of the key new FDA EUAs and clearances that were announced in February 2023:

New FDA Approvals & Emergency Use Authorizations (EUAs)

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Other international clearances announced in February 2023: