www.fdanews.com/articles/211711-products-with-emergency-authorizations-to-stay-available-after-end-of-phe

Products with Emergency Authorizations to Stay Available After End of PHE

April 4, 2023

Despite the approaching end of the COVID-19 public health emergency (PHE) in the U.S., medical products approved under emergency use authorizations (EUA) will remain available for the foreseeable future, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), in the New England Journal of Medicine (NEJM).

At the time the article went to press, the official end of the PHE was to be May 11 under President Biden’s plan. But both the House and the Senate passed a joint resolution to declare an immediate end to the PHE. The president said this week he would not use his veto power to overturn the resolution.

The Senate passed the joint resolution on March 29 by a vote of 68-23. The House previously voted 229-197 in February to end the PHE, with 11 Democrats joining 218 Republicans in support of the move.

Marks said in the NEJM article that since the FDA knew the end of the PHE was nigh, the agency already had begun working with holders of EUAs to transition them to full approval.