COVID Emergency Officially Ends Today but Not EUAs: FDA
(Thursday, May 11, 2023)
As of today, 11 May 2023, the Public Health Emergency (PHE) for COVID-19 declared in January 2020 expired but this would not affect the various products authorized for Covid via Emergency Use Authorization (EUA). This is because under US laws, the PHE and the EUA are not linked. PHE refers to specific emergency measures to address a health emergency such as “making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder.” The PHE does not create a process for EUAs. The EUAs are issued under a separate provision of the law called the “EUA Declaration”. The PHE is issued for 90 days at a time and can be extended for subsequent 90-day periods as long as the Secretary of the Department of Health and Human Services (DHHS) continues extending it. It is the last 90-Day period of the PHE for Covid that expired today. The EUA Declaration on the other hand can continue indefinitely once issued and does not need to be renewed. It can only be terminated by the DHHS Secretary. So, technically, EUAs can survive much after the PHE has expired. That is why FDA still has active EUAs for Anthrax, Ebola Virus, H7N9 influenza, MERS-CoV, Nerve Agent and Zika Virus. So, all the diagnostic tests authorized for Covid-19 under EUAs, will continue to be available after today. The process for terminating an EUA Declaration is more gradual than that for the PHE. FDA would announce the termination of the EUA Declaration and give reasonable time to the EUA manufacturers to either dispose/distribute their inventory and prepare to stop selling or allow them to transition to conventional approval. For conventional approval, FDA allows recycling data used to support the original EUA. FDA published a guidance document in March this year describing the process for transition of EUA devices to conventional approval post the end of the EUA Declaration. For now, the products authorized under Covid EUA has no reason to rush to transition as FDA has still not even announced the termination of the relevant EUA Declarations, and Covid infections are still abundant to justify having these products, particularly the diagnostic tests, to stay available. That said, the demand for the EUA products has dissipated exponentially from the peak pandemic numbers, so many of these products are already and would slowly leave the market for practical reasons.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC