Emergency Use Authorizations in a Post-Emergency World

According to the U.S. Department of Health and Human Services (HHS), the COVID-19 Public Health Emergency will expire in May, but Emergency Use Authorizations and liability protection will continue after the emergency ends.

Early in the pandemic, we were told that Emergency Use Authorizations were necessary to make unlicensed, unapproved tests, vaccines, and treatments available during an emergency.  On January 31, 2020, the Health and Human Services Secretary declared the COVID-19 pandemic a public health emergency, paving the way for these products.  The secretary even invoked the liability protection of the PREP Act to encourage manufacturing of countermeasures.  Soon, the FDA began issuing Emergency Use Authorization letters which close with a notice that the authorization will terminate when the emergency is over.

Last month, the HHS secretary signaled his intention to end the emergency on May 11, 2023.  At the same time, the secretary assured us that Emergency Use Authorizations will not be affected.  According to the statement, “Existing EUAs for COVID-19 products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met.”

The Federal Food, Drug, and Cosmetic Act was amended several times by the Consolidated Appropriations Act, 2023 (see page 1339, for example).  Did these amendments give FDA authority to issue EUAs without an emergency?  I cannot tell you because, frankly, I get lost in the language.  HHS claims its authority for EUAs in the absence of an emergency declaration dates back a decade, to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.  Regardless, the intention is clear: EUAs will continue after the emergency is lifted.

And what will become of those PREP Act liability protections?  According to HHS, these will also continue, but only for a select group of manufacturers:

Currently, the amended PREP Act declaration provides liability immunity to manufacturers, distributors, public and private organizations conducting countermeasure programs, and providers for COVID-19 countermeasure activities related to a USG [United States Government] agreement (e.g., manufacturing, distribution, or administration of the countermeasures subject to a federal contract, provider agreement, or memorandum of understanding). That coverage will not be affected by the end of the PHE. However, PREP Act liability protections for countermeasure activities that are not related to any USG agreement (e.g., products entirely in the commercial sector or solely a state or local activity) will end unless another federal, state, or local emergency declaration is in place for area where countermeasures are administered. HHS is currently reviewing whether to continue to provide this coverage going forward.

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, February 9, 2023

Manufacturers of EUA products that have an agreement with the US Government will continue to have liability protection.  Other manufacturers will not.  Collusion between the federal government and big businesses like this asymmetric post-emergency liability protection is the very definition of fascism.  

If Emergency-Use-Authorizations without an emergency seem illogical to you, you are not alone.  Even members of congress have assumed that EUAs will end with the emergency declaration.  

This is not just an assault on language and logic.  It is an assault on liberty.  

The emergency declaration will end soon, but the emergency power-grab will continue indefinitely.