In this installment in our series explaining key terms and phrases used by public health officials in discussions of the COVID-19 pandemic, we look at the term “emergency use authorization.”
As researchers continue to study COVID-19, identifying treatment options remains a key objective. One pathway for emerging COVID-19 treatments to become available is through a mechanism called an emergency use authorization (EUA), which is granted by the U.S. Food and Drug Administration (FDA).
The FDA is the federal agency charged with determining whether newly developed drugs, diagnostic tests, and medical devices are found to be safe and effective before these products can be marketed to the public. Under normal circumstances, the FDA approval process is rigorous and requires a high level of scrutiny. However, during a public health emergency, the FDA commissioner may grant EUAs to unapproved medical products or unapproved uses of medical products to combat an emerging threat like COVID-19.
The FDA commissioner has utilized emergency use authorizations during the public health emergency declared in response to the COVID-19 pandemic. For example, the antiviral drug remdesivir recently received an EUA for the treatment of severely ill patients hospitalized with COVID-19. EUAs have also been granted for multiple COVID-19 diagnostic tests and some medical devices, including ventilators. In making these decisions, the FDA evaluates these products based on the best available evidence, weighing associated risks against potential benefits. On March 16, the FDA began allowing states to establish systems to develop and authorize tests without submitting them to the FDA if the states are willing to assume risk of liability, as noted in our COVID-19 testing explainer.
It is important to note that an emergency use authorization does not equate to FDA approval. The EUAs granted to help fight COVID-19 are only in effect for the duration of the public health emergency. For this reason, it is critical that therapeutics still undergo clinical trials for continued information gathering and that tests are continually monitored for their efficacy.