WASHINGTON, D.C. — The U.S. Department of Health and Human Services is ending the emergency declarations that allowed the rapid authorization of COVID-19 drugs, biologics and medical devices, marking another step in the federal government’s transition away from pandemic-era regulatory authorities.
Health and Human Services Secretary Robert F. Kennedy Jr. signed determinations terminating the COVID-19 Emergency Use Authorization declarations, the department announced Monday, concluding that the conditions that justified the emergency measures no longer exist.
The move will not take effect immediately. The declaration covering drugs and biological products will expire 12 months after the secretary’s determination, while emergency authorizations for medical devices will end after 180 days.
The Emergency Use Authorization declarations were first issued in 2020 to accelerate access to vaccines, tests, treatments and medical devices during the COVID-19 pandemic.
“By ending these COVID-19 emergency use authorization declarations, we’re reinforcing public confidence that emergency authorities are temporary and targeted,” Kennedy said in a statement.
HHS said the public health landscape has changed significantly since the pandemic’s early stages, with FDA-approved, cleared and licensed products now widely available through traditional regulatory pathways. The department also noted that reliance on products authorized solely under emergency powers has declined and manufacturers have had years to prepare for the transition.
The extended wind-down periods are intended to give manufacturers, healthcare providers, health systems, distributors and patients time to adjust as products that remain on the market solely through emergency authorization pursue traditional regulatory approval, clearance or licensure.
HHS and the Food and Drug Administration said they will continue working with manufacturers during the transition process.
The department said it has published notices of the terminations in the Federal Register and has provided the notifications to Congress required under federal law.
The decision further unwinds emergency measures put in place during the pandemic and signals the administration’s view that the regulatory framework established to address COVID-19 is no longer necessary given the availability of approved medical products and the current state of the public health response.
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