Syringe being filled from a vial. Vaccine concept illustration.

From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization

Cross-posted from COVID-19 and The Law, where it originally appeared on January 14, 2021. 

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The ongoing fight against COVID-19 has thrown a spotlight on the Food and Drug Administration (FDA) and its power to grant emergency use authorizations (EUAs). EUA authority permits FDA to authorize formally unapproved products for temporary use as emergency countermeasures against threats to public health and safety.

Under § 564 of the Food, Drug, and Cosmetic Act (FD&C Act), use of FDA’s EUA authority requires a determination that an emergency exists by secretaries of the Department of Homeland Security, the Department of Defense, or the Department of Health and Human Services (HHS), as well as a declaration by the HHS Secretary that emergency circumstances exist warranting the issuance of EUAs. Each issuance of an EUA requires that FDA conclude that:

  • it is reasonable to believe that a given product “may be effective” as an emergency countermeasure,
  • the known and potential benefits of authorization outweigh the known and potential risks, and
  • no formally approved alternatives are available at the time.

Annie Kapnick’s post on COVID-19 and FDA’s EUA authority provides a helpful overview of FDA’s emergency powers and their use in response to the pandemic. A brief look at the history of FDA’s emergency powers, including key events leading up to their enactment — Thalidomide, swine flu, AIDS, and 9/11 — offers perspective on the situation facing FDA today and its implications for the future. The history of EUA illustrates how its use today against COVID-19 involves fundamental questions about the role of public officials, scientific expertise, and administrative norms in times of crisis.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

COVID-19 and the FDA Emergency Use Authorization Power

Cross-posted from COVID-19 and The Law, where it originally appeared on November 10, 2020. 

By Anne Kapnick

The Food and Drug Administration (FDA) is responsible for protecting public health by regulating the production, distribution, and consumption of food, cosmetics and drugs. In the healthcare arena (the focus of this post), the FDA strives to ensure the safety, efficacy, and security of drugs, biological products, and medical devices. The FDA also ensures that the “public get[s] the accurate, science-based information they need to use medical products and foods to maintain and improve their health.” This blog post provides an overview of the FDA’s emergency authorization powers, analyzes the extent of their usage in the COVID-19 pandemic, and concludes by flagging potential concerns regarding the FDA’s management of this vast power.

Click here to read the full post on COVID-19 and The Law.