The Food and Drug Administration can issue an EUA during public health emergencies, allowing the use of unapproved medical products, or unapproved uses of already approved medical products, to diagnose, treat or prevent life-threatening diseases. Certain criteria must be met to allow EUA.
EUA allows providers and public health officials to use unapproved diagnostic, treatment, or prevention measures to counteract a national security threat, such as a pandemic.
Health officials must follow specific steps and meet certain criteria to have the FDA approve a EUA.
The Project Bioshield Act created the EUA program in 2004 to protect the public or U.S. military during a significant threat to national security. During an emergency, the FDA reviews the potential benefits and risks of providing a EUA to the public while ensuring the EUA’s safety, efficacy and security.
EUA allows public health officials and physicians to quickly mobilize the best diagnostic, treatment and prevention measures available during emergency situations. Under EUA, these measures do not have to be FDA-approved or approved for their particular use. For example, the FDA may have approved a device to diagnose a certain virus, which we’ll call Huddle Virus.
During an emergency situation such as a pandemic, it may turn out that this device could help diagnose the virus that’s causing the pandemic. Although the FDA approved the device to only detect the Huddle Virus, the organization may approve EUA for providers to use this device to detect the virus that’s causing the pandemic.
Steps to EUA:
1) Determination of an emergency
- Made by HHS, Department of Homeland Security or Department of Defense
2) Declaration of an emergency
- Any variety of emergency that threatens national security
3) Review of the request for EUA by the FDA
4) Issuance of the EUA or denial of the request
5) Termination of the EUA
The EUA must meet four criteria for the FDA to even consider approval for use.
There must be a serious or life-threatening illness known to be caused by a certain microbe (e.g. virus) or chemical, nuclear or radiological agents.
It’s reasonable to believe that the medical product approved for EUA will be effective for its intended use.
The benefits, or potential benefits, of the product used under EUA must outweigh the risks or potential risks.
The product is the best countermeasure against the threat causing the emergency.
EUA in Action
The FDA has used EUA during the following outbreaks:
H1N1 (swine flu)
Outside the Huddle