Emergency Use Authorization

Emergency Use Authorization (EUA) is a legal means by which the United States Food and Drug Administration (FDA) can approve new drugs or medical devices, or new uses for existing drugs or devices, during a declared public health emergency. The EUA process is different from Fast Track, Accelerated Approval, and Priority Review processes, which are intended to speed up the normal FDA approval process for promising drugs.

History

The concept of EUA was first introduced in the Project BioShield Act of 2004, which was enacted in response to the anthrax attacks of 2001. The law allows the FDA to authorize the use of unapproved medical products or unapproved uses of approved medical products during a declared emergency, when there are no adequate, approved, and available alternatives.

Process

The EUA process begins when a public health emergency is declared by the Secretary of Health and Human Services (HHS). The FDA then reviews available scientific evidence, including data from clinical trials, to determine whether a medical product is likely to be effective in preventing, diagnosing, or treating a disease or condition, and whether its potential benefits outweigh its potential risks.

If the FDA determines that these criteria are met, it can issue an EUA, which allows the product to be used in the emergency situation. The EUA includes specific conditions that must be met, such as informing patients that the product is being used under an EUA and monitoring and reporting adverse events.

Examples

One of the most notable examples of EUA was the authorization of COVID-19 vaccines during the COVID-19 pandemic. In December 2020, the FDA issued EUAs for the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine, followed by the Johnson & Johnson’s Janssen COVID-19 vaccine in February 2021.

Criticism

While the EUA process has been praised for its ability to quickly make potentially lifesaving treatments available during emergencies, it has also been criticized for potentially bypassing the rigorous testing and review process that normally applies to medical products. Critics argue that this could lead to the approval of products that are ineffective or unsafe.

See also

• Compassionate use
• Investigational New Drug
• Right to try law

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