Planning for the End of the COVID-19 Public Health EmergencyOctober 14, 2022
“We still have a problem with COVID. We’re still doing a lot of work on it. But the pandemic is over. If you notice, no one is wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing.”
President Biden made this comment in a “60 Minutes” interview on September 18, 2022. The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency.
Before we talk about the future, let’s briefly review the history. It was January 31, 2020 when the Secretary of the Department of Health and Human Services (HHS) first declared the 2019 Novel Coronavirus (2019-nCoV) outbreak a public health emergency (PHE), pursuant to Section 319 of the Public Health Service Act (see here). Two separate emergency declarations were then made—one pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act by the Secretary of HHS on February 4, 2020 (see here), and the other under the Public Readiness and Emergency Preparedness (PREP) Act by the Secretary of HHS on March 17, 2020 (see here). Shortly thereafter, then-President Trump made a national emergency declaration on March 18, 2020, pursuant to Section 201 of the National Emergencies Act (see here). If you haven’t checked out the CDC Museum COVID-19 Timeline, please check it out here.
Among these many declarations, which declaration is pertinent to FDA’s issuance of an emergency use authorization (EUA)? It is the one that is issued pursuant to section 564 of the FD&C Act. In other words, even if the Secretary of HHS declares that the public health emergency is over, under section 319 of the Public Health Service Act, an EUA that was granted under section 564 of the FD&C Act will continue to remain in effect.
Under section 564(b) of the FD&C Act, the Secretary of HHS must publish advanced notice in the Federal Register that an EUA declaration will be terminated. For medical devices, FDA noted in the 2021 December draft guidance (see here) that it will provide 180 days advanced notice before terminating the EUA declaration. Once the Secretary terminates an EUA declaration, then any EUAs issued based on that declaration will no longer be in effect. (The exception being instances where under section 564(f)(2), an unapproved product continues to be effective to provide for continued use with respect to a patient to whom it was administered while the declaration remains effective, to the extent found necessary by such patient’s attending physician.)
This advanced notice allows for an effective transition period. For unapproved products with EUAs, the transition period allows time for proper product disposition. For unapproved uses of approved products, the transition period allows time for companies to update labeling or other associated materials. The December 2021 draft guidance document sets forth a pathway for unapproved medical devices to obtain permanent marketing authorization. We previously blogged on this guidance document here.
“The advance notice of termination of each EUA declaration pertaining to devices will be published in the Federal Register 180 days before the day on which the EUA declaration is terminated.”
FDA provides FAQs about what happens to EUAs when a public health emergency ends (see here). We all look forward to the end of the COVID-19 pandemic. But if you are a medical product manufacturer, the news of the termination of COVID-19 PHE could complicate your business plan. Therefore, plan your transition strategy in advance and be on the lookout for the 180-day advance notice!