Dive Brief:
- The Department of Health and Human Services late Thursday extended the public health emergency (PHE) declared for the COVID-19 pandemic, as was flagged in a tweet from Secretary Alex Azar. The extension takes effect Saturday.
- The move was expected but came just days before the emergency was scheduled to expire. It was first declared Jan. 31, retroactive to Jan. 27, and was previously renewed April 21. The declarations last for 90 days, meaning an expiration or renewal of the current extension could come in late October, or whenever the secretary deems that the PHE no longer exists — whichever comes sooner.
- The PHE provides a host of regulatory flexibilities, including allowing the HHS secretary to let FDA grant emergency use authorizations, the first of which came in early February.
Dive Insight:
When Azar first declared the COVID-19 PHE at the end of January, he said in a statement "the risk to the American public remains low." This week, the U.S. number of infections passed 4 million.
Extending the PHE allows a number of regulatory changes that have been enacted to help providers manage outbreaks of the novel coronavirus to continue, including the rollback of telehealth restrictions that have eased access to virtual visits.
As of Thursday, FDA had authorized 187 coronavirus tests under EUAs: 154 molecular diagnostic tests, 31 antibody tests and two antigen tests.
AdvaMed, the American Clinical Laboratory Association and the American Hospital Association were among the groups that urged HHS to renew the PHE.
AdvaMed said that the ramp up in production in personal protective equipment, diagnostic supplies and ventilators "would not have been possible without the regulatory flexibilities and availability of resources facilitated by the PHE."
ACLA and more than a dozen other health organizations wrote that "maintaining the PHE status is required if we are to increase the pace of research on SARS-CoV-2, accelerate development of medical countermeasures, streamline efforts to bring novel diagnostics, vaccine candidates and therapeutic options to market, and ensure that the public has access to health care and other social services."
Today I signed a renewal of the COVID-19 national public health emergency declaration. The Administration will continue its whole-of-America response to ensure Americans can get the care they need throughout the pandemic. pic.twitter.com/yGIr8hja3a
— Secretary Alex Azar (@SecAzar) July 23, 2020
A department spokesperson said at the end of June the agency expected to renew it, but no official confirmation was given until Thursday.
