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March 05, 2021

What is an Emergency Use Authorization?

Prevention Emergency Use Authorization

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Until recently, you may have never heard the term “Emergency Use Authorization.” These words entered the lexicon as people around the world anxiously read updates about the COVID-19 pandemic and awaited the development of tests and treatments that could help contain it.

An Emergency Use Authorization (EUA) provides the U.S. Food & Drug Administration (FDA) with the authority to make medical products and supplies available to protect public health during an emergency. While EUAs have been around a long time, their newfound prominence and association with COVID-19 may have you asking more about them.

How drugs and medicines are usually approved

The standard process for approving drugs, diagnostics, or medical products in the United States is exceptionally deliberate. When a drug is “FDA Approved,” it means that it has undergone rigorous scientific testing by the FDA. These reviews are independent from manufacturers to ensure that a drug or treatment is safe and effective. Only after years of testing and evaluation do the absolute safest drugs and treatments receive the “FDA Approved” label.

Why an Emergency Use Authorization?

In a public health emergency, such as the current coronavirus pandemic, the FDA can issue an EUA to make critical medical supplies available. With thousands of Americans dying each day from COVID-19, granting additional access to drugs, testing, or other treatments quickly can save lives.

EUAs still require a robust approval process based on robust clinical trials. Administrators examine the data and information they have available on a given treatment and evaluate its effectiveness related to the health emergency. They weigh the risks versus the benefits of approving the treatment based on the available data, and then make a decision about its use.

What happens when an Emergency Use Authorization is granted?

An EUA is tied to the specific emergency for which its approved. Once issued, the diagnostic testing or treatment that has been approved will be put into use by healthcare providers. The FDA continues to monitor available evidence to adjust or revoke EUAs, consistent with the most reliable data available at the time. EUAs are not only granted to new treatments. Existing treatments or drugs may also be approved for new uses (such as treating COVID-19) more quickly this way.

You can trust that drugs or treatments made available under an EUA are safe for use during the public health emergency for which they are approved. Each treatment authorized under an EUA is still carefully vetted, and it’s in the FDA’s interest to ensure that only the safe and most effective treatments receive an EUA.

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