Renewal of Public Health Emergency Means FDA’s Pandemic Guidance Still Applies

It’s official: The public health emergency (PHE) that is COVID-19 will continue for at least three more months.

The Department of Health and Human Services (HHS) released a statement last week, declaring that it was extending the COVID-19 PHE for another 90 days. This means the drug industry needs to continue to adhere to the many guidances FDA released that contain pandemic-specific directives, some of which added new tasks for firms to undertake and others of which allowed companies relief from completing certain operations due to the risk the pandemic carries.

The FDA issued 79 COVID-19-related guidances to help companies adjust their operations to the pandemic between March 2020 and April 2022. Of those, 39 were aimed at makers of drugs, biologics and gene therapies, while 19 were directed at makers of medical devices.

Some of the guidances focused on temporary situations, such as drug shortages, but others altered the way companies did business.

HHS said that it will give 60 days notice before terminating the PHE.

The renewal of the PHE also allows U.S. citizens continued access to free tests, vaccines and treatments.

The PHE was originally declared on Jan. 27, 2020, and has continually been extended every 90 days since. The last extension was made on Jan. 14 and was due to expire April 16.

In addition to the renewed PHE, a separate nationwide health emergency that’s in place allows the FDA to grant Emergency Use Authorizations (EUAs) for COVID-19 treatments, tests and vaccines.

Fourteen COVID-19-related drugs, 630 devices and diagnostic tests, and one vaccine currently only have EUAs that be in effect only as long as the public health emergency lasts.

During the two years and two months of the pandemic thus far, full approval was granted to only two vaccines (Pfizer and Moderna), one drug (remdesivir) and two diagnostic tests.

“The renewal was expected and it is needed to maintain our capacity to monitor the epidemic in the U.S. and globally,” said Ali Mokdad, an epidemiologist at the University of Washington who previously served in numerous roles over two decades at the Centers for Disease Control and Prevention (CDC), in an email to FDAnews.

Mokdad said any further extensions will depend on the spread of the virus in the U.S. and elsewhere.

“We do not project a rise in cases after this short slowdown in the decline and a small rise in some states,” he said. “We expect cases to decline all the way until next winter.”

Mokdad said epidemiologists are monitoring the situation in China and the reporting of a new variant in South Africa.

Additionally, he predicted that U.S. health agencies won’t declare an end to the PHE until long after important drugs that now only have an EUA have had time to get full approval.

It’s unclear when the PHE may be declared over, as there is no agreed-upon threshold for declaring that a public health emergency is over, said epidemiologist Lynn Goldman, dean of the school of public health at George Washington University (DID, March 14). — Suz Redfearn