Clint Hermes Discusses EUA Status for Medical Products When Public Health Emergency Ends

March 4, 2022
STAT News

In an article for STAT News, Bass, Berry & Sims attorney Clint Hermes provided insight on what could happen to medical products – such as vaccines, therapeutics and other medical supplies – that were granted an emergency use authorization (EUA) during the pandemic once the U.S. government declares the public health emergency has officially ended. Public health emergencies can be declared under the Public Health Service Act and the Food, Drug and Cosmetic Act, with different implications for each. As the government plans for when and how to end the public health emergency established early on during the pandemic, the article examines the many temporary policies and procedures that were put in place to help individuals, businesses and state and local governments survive.

The situation is complicated for medical products because an EUA declaration can remain in place even if a public health emergency is no longer in effect. “You would think they would be related, but they are not necessarily,” said Clint. “It’s hard to intellectually square how you would terminate one declaration but not terminate them all, but it doesn’t mean that it couldn’t happen.”

The full article, “Why Formally Ending the Pandemic is Going to be a Huge Headache for the Entire Health Care System,” was published by STAT News on March 3 and is available online (subscription required).