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?
EUA Is Not a Designation for an Experimental Product Undergoing a Clinical Trial
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.EUA is also not the same as Expanded Access Use (EAU), often called “compassionate use” access, which applies to granting patients with severe, incurable diseases access to experimental products before they are fully approved.
Here’s what this table tells us about EUA:
1. The process of granting EUA is not likely to generate any information about a product’s effectiveness.
2. The process of granting EUA is not designed to provide evidence of safety or effectiveness, but safety signals might be identified.
3. It is unlikely, once a product is granted EUA and administered to some patients, that any useful information will be obtained to benefit any future patients.
4. There is no systematic data collection on effectiveness or safety with EUA, and no data is published in medical journals as part of the regulatory approval process.
5. No informed consent is required, but patients who “volunteer” to take the product must be told they can refuse and that the product is unapproved/available under EUA.
“It is important to recognize that an EUA is not part of the development pathway; it is an entirely separate entity that is used only during emergency situations and is not part of the drug approval process.” (p. 28)
To summarize:
Based on all this very clear information from the CDC/FDA and the IMNA, it would be fair to conclude that Emergency Use Authorization is a process that should be applied very judiciously and only in cases of dire emergencies.
Now let’s look at what types of emergency situations EUA is legally designed to address.
The laws permitting the EUA “Access Mechanism” described above were drawn up for cases of extreme, immediate emergencies involving weapons of mass destruction (WMD), also referred to as CBRN (chemical, biological, radiological, nuclear) agents.
“With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives (among other criteria).”
These EUA powers were granted in 2004 under very specific circumstances related to preparedness for attacks by CBRN agents.
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 3 Steps for Emergency Use Authorization (EUA)
Three things have to happen in order for EUA to be granted to a medical product:1. The Secretary of Homeland Security, the Secretary of Defense, or the Secretary of Health and Human Services needs to determine that there is an emergency involving an attack or a threat of an attack with a CBRN agent or a disease caused by such an agent.
2. The FDA needs to make sure that it meets four “statutory criteria” when it issues 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. It must be issued specifically for the purpose of activating EUA and can be ended or extended independently of any other emergency declaration.1. a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents;
1. a biological, chemical, radiological, or nuclear agent or agents; or
2. an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces;
3. a determination by the Secretary [of Health and Human Services] that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; orEUA Step 2. Meeting the Statutory Criteria
Once one of the secretaries has declared that there is an emergency that warrants EUA, there are four more “statutory criteria” that have to be met in order for the FDA to issue the EUA. Here’s how the FDA explains these requirements:1. Serious or Life-Threatening Disease or Condition
“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.”
2. Evidence of Effectiveness
“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).
3. Risk-Benefit Analysis
“A product may be considered for an EUA if the Commissioner determines that the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product.
4. No Alternatives
EUA Step 3. Imposing the Required Conditions
Once we have the EUA-specific emergency declaration, and once the FDA determines that the product may be effective and that whatever evidence is available shows that its benefits outweigh its risks, there is one more layer of related regulation.“FFDCA §564 directs FDA to impose certain required conditions in an EUA and allows for additional discretionary conditions where appropriate. The required conditions vary depending upon whether the EUA is for an unapproved product or for an unapproved use of an approved product. For an unapproved product, the conditions of use must:
“(1) ensure that health care professionals administering the product receive required information;
“(2) ensure that individuals to whom the product is administered receive required information;
“(3) provide for the monitoring and reporting of adverse events associated with the product; and
Conclusion
As noted in this article, the FDA/CDC clearly recognize that the process of granting Emergency Use Authorization (EUA) is unlikely to generate any information about the effectiveness or safety of a product. When we look at the letter of the law governing EUA, we see that this is, indeed, a correct assessment.The EUA law does not impose any legal or regulatory standards that might determine whether a product is safe or effective. The only standards are whether the FDA believes the product may be effective and that its known benefits outweigh its known harms. If there are no known harms or known benefits, because the product has never been through the drug approval process, the FDA can use whatever information or standards it chooses to make that determination.
It follows from all of this that a company whose product is a candidate for EUA may attempt to demonstrate the product’s safety and/or effectiveness through whatever means it chooses. The existence of such an attempt (whether a clinical trial or other data-collecting mechanism), and how that attempt is conducted, are all up to the company. Nothing in the EUA law applies to how the company designs, conducts or analyzes any studies or other data-collecting mechanisms it chooses to pursue.
Applied to COVID products this means:
• No safety or efficacy data from clinical trials were required in order for COVID products to receive EUA.
• Any clinical trials referred to in the EUA process were conducted with no legally applicable regulatory standards.
• When we find out that these products lack efficacy or safety, that is not a surprise. It is a highly likely result of the process.
• There is no data from the EUA process on which to base non-EUA decisions about safety or efficacy of the product. So any non-EUA use of the product would require going through the legal approval process for regular medical products from the beginning.