What Is Emergency Use Authorization?

During the Covid pandemic, the U.S. government spent billions of dollars on nearly 400 products intended to protect, diagnose, and treat hundreds of millions of people – all with the label “EUA” or “Emergency Use Authorization.” But what does EUA actually mean?

If we only understand one thing about EUA it should be this: EUA does not apply to a product undergoing a clinical trial governed by FDA regulations or other legal requirements.

Now let's look at what types of emergency situations EUA is legally designed to address.

Given such a narrow type of truly extreme emergency situation involving a WMD attack, it is understandable why the EUA "Access mechanism" does not require a lot of regulatory oversight or adherence to any manufacturing or clinical trial standards.

The FDA needs to make sure that it meets four "Statutory criteria" when it issues the EUA. The FDA has to "Impose certain required conditions" in the EUA. EUA Step 1: Declaring a CBRN Emergency.

The emergency declaration for EUA is separate and unrelated to any other emergency declarations that may be issued by the President, the HHS Secretary, or anyone else.

For the FDA to issue an EUA, the CBRN agent(s) referred to in the HHS Secretary's EUA declaration must be capable of causing a serious or life-threatening disease or condition.

Medical products that may be considered for an EUA are those that "May be effective" to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a CBRN agent(s) identified in the HHS Secretary's declaration of emergency or threat of emergency under section 564(b). 

https://brownstone.org/articles/what-is-emergency-use-authorization-eua/