US FDA Emergency Use Authorization (EUA)

 An Emergency Use Authorization (EUA) is a mechanism allows the use of medical countermeasures during public health emergencies.

FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency.

Medical countermeasures examples, FDA-regulated products (biologics, drugs, devices).

Public health emergencies examples: Covid 19, Anthrax, Ebola Virus, H7N9 Influenza, Zika Virus.

 When EUA is used:

Domestic emergency/ Military emergency/ Public health emergency involving heightened risk of attack with a chemical, biological,radiological, or nuclear (CBRN) agent and Material threat affecting national security or the health and security of United States citizens living abroad.

 Process of EUA.

 EUA Declaration:Health and Human Services (HHS) Secretary issues an EUA declaration.

The below figure shows the EUA sumission process.

EUA submission contents,

Based on below criteria,FDA may issues EUA,

• Serious or Life-Threatening Disease or Condition
• Evidence of Effectiveness :"may be effective" standard for EUAs provides for a lower level of evidence than the "effectiveness" standard that FDA uses for product approvals
• Risk-benefit analysis the device’s known and potential benefits regarding treating, diagnosing or preventing disease
• Lack of adequate, FDA-approved/cleared or available alternative treatment

The FDA commissioner issues a letter that authorizes the EUA. The letter must state:

• the diseases or conditions the product may be used to diagnose, prevent, or treat within the scope of the EUA
• the known and potential benefits of the product
• conclusions concerning the safety and potential effectiveness of the product
• an assessment of the available scientific evidence; and
• required and additional conditions of authorization

Usually EUA last for 1 year after approval,but EUA shall be renewed until public health emergency lasts.

References:

Federal Food, Drug, and Cosmetics Act, as amended. Codified at 21 U.S.C. 301 et seq.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities