While July 15 may or may not be the final day, it seems clear that the Public Health Emergency (PHE) is coming to an end before the end 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.
Explanation: COVID tests have reached the market via the Emergency Use Authorization (EUA) pathway. EUA status remains valid for as long as the PHE that prompted it remains in effect. While we may be through the pandemic phase, COVID-19 isn’t going to disappear from the face of the earth when the PHE ends. The result could be a massive disruption in COVID-19 tests. The good news is that under Section 564 of the Food, Drug, and Cosmetic Act, the FDA can continue issuing EUA for tests after a PHE is no longer in effect.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 in recent years. 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 said.