EUA COVID-19 Tests to Remain on US Market After PHE Expires

On April 20, the U.S. Department of Health and Human Services (HHS) extended the public health emergency (PHE) another 90 days to July 15. This may or may not prove to be the final 90-day extension. But one thing we know for sure is that the PHE is approaching its end, probably by the close of the year. And when it does, almost every single COVID-19 test currently on the US market stands to lose the legal basis of its approval. Of course, the FDA recognizes this situation and has signaled that test makers won’t be left high and dry when the PHE ends.

EUA Status Is Temporary, but COVID-19 Isn’t

When the PHE began, SARS-CoV-2 was a totally unknown virus and there were no lab tests designed to detect it. As a result, the FDA authorized, and continues to authorize, SARS-CoV-2 tests on an emergency basis using its authority—under Section 564 of the Food, Drug & Cosmetics Act (FDCA)—to authorize unapproved products in the event of an emergency. Since the PHE began, more than 300 SARS-CoV-2 diagnostic products have reached the US market via the Emergency Use Authorization (EUA) pathway. Technically, EUA authorization remains valid for as long as the PHE that prompted it remains in effect. While, as National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci recently suggested, we are through the pandemic phase, COVID-19 isn’t going to disappear from the face of the earth any time soon. As a result, the SARS-CoV-2 virus will still be around if and when the PHE ends. And that means current EUA tests will lose their approval status. While a couple of COVID-19 tests have received full FDA approval, there may not be enough of them for labs to use to diagnose COVID-19 once the PHE ends.

FDA Response

One way to avoid disruption would be for makers of EUA tests to seek full approval for their products. Last December, the FDA released draft guidance encouraging manufacturers to do that, outlining a pathway for transitioning from EUA to full marketing and regulatory approval. Specifically, it recommends that manufacturers seeking full approval for their tests to include in their submissions a transition plan for dealing with products that they’ve already distributed that includes:

• The estimated number of tests currently in distribution in the US;
• An explanation of how the manufacturer will dispose of products that it has already distributed if the FDA denies its application for marketing approval; and
• An explanation of how the manufacturer will deal with previously distributed products if the FDA approves the marketing submission.

If the manufacturer proposes to leave the already distributed products in place, the transition plan should explain the rationale for doing so and set out a process for notifying providers, health care facilities, distributors, patients, and consumers of the product’s regulatory status. The guidance adds that the plan should also provide for what happens if a submission is denied with already distributed products left on the market by including a process and timeline for both restoring those devices to the previously FDA-cleared or approved version and “providing publicly available labeling that accurately describes the product features and regulatory status.” The plan should also include a maintenance plan for distributed products. Manufacturers must also include a process and timeline for providing users updated labeling or components reflecting changes made to the product if a marketing submission is approved, according to the guidance. If the manufacturer has submitted its test for marketing approval and had it accepted by the FDA before the EUA termination date, the guidance adds, the test may continue to be distributed, with updated labeling, until the agency reaches a final decision.

Government Action to Keep EUA Tests Available

Despite the FDA guidance, to date, fewer than half a dozen COVID-19 tests have received 510(k) or de novo clearance. Accordingly, it looks like the federal government will have to take action to keep EUA tests legally on the market after the PHE ends. Under Section 564 of the FDCA, the FDA can continue issuing EUA for tests after a PHE is no longer in effect. Accordingly, tests for Zika, MERS, and Ebola have received EUA. The agency is signaling that it intends to exercise its Section 564 authority. In a recent virtual town hall meeting, Toby Lowe, associate director for regulatory programs in the FDA’s Office of In Vitro Diagnostics and Radiological Health, offered reassurances that the agency will give manufacturers at least 180 days’ notice before pulling their EUA. The agency isn’t going “to take any actions that would leave the American public without the tests that they need,” Lowe suggested. This echoes language in the December guidance suggesting that SARS-CoV-2 tests with EUA approval produced by manufacturers that don’t intend to seek full marketing approval and that have already been distributed may be used for two years after the EUA termination date, or until they expire.

Takeaway

The end of the PHE won’t result in the abrupt and immediate disappearance of COVID-19 EUA tests. While the details and timetable still need to be worked out, it’s clear that the FDA will provide a transition period and that tests will remain on the market for at least six months after the PHE expires.