Secretary of Health and Human Services Robert F. Kennedy Jr. terminated a key piece of the COVID-19 response.
The Department of Health and Human Services announced Tuesday that Secretary Kennedy terminated the Emergency Use Authorizations (EUAs) for drugs and medical devices. The EUAs were put in place by then-Secretary Alex Azar after the initial outbreak of the pandemic in 2020.
"The COVID-19 EUA declarations were first issued in 2020 to enable rapid access to medical products during the pandemic," the Department said in the press release. "Since then, the public health landscape has changed substantially. FDA-approved, cleared, and licensed products are now widely available through traditional regulatory pathways, reliance on EUA products has declined, and manufacturers have had years to prepare for a transition from emergency authorities."
The Department said the terminations will follow periods of advance notice to ensure and orderly transition for manufacturers and supply chains. The medical device EUA will end in 180 days, while the EUA for drugs and biologics will expire in 12 months.
"The advance notice periods are designed to provide manufacturers, healthcare providers, health systems, distributors, and patients adequate time to transition away from products authorized solely under the COVID-19 EUA declarations," HHS said. "During this transition, HHS and the Food and Drug Administration (FDA) will continue working with manufacturers on appropriate regulatory pathways for products seeking traditional approval, clearance, or licensure. HHS will publish notices of the terminations in the Federal Register and provide the notifications required by law to Congress."
