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Publication Date

12-2021

Abstract

The SARS-CoV-2 pandemic spurred the U.S. Food & Drug Administration (FDA) to utilize the Emergency Use Authorization (EUA) procedure more than ever before. The pandemic pushed the relatively obscure procedure into public consciousness, making it a frequent topic of discussion and debate. The EUA procedure permits the FDA Commissioner to authorize the introduction of drugs, devices, or biological products into interstate commerce for use in an actual or potential emergency. To issue an authorization, the FDA Commissioner must determine that it is “reasonable to believe,” based on the “totality of the evidence,” that the product “may be effective.” This standard creates a lower evidentiary burden than the traditional pathways to market for drugs and vaccines in the United States, allowing the FDA to respond quickly and effectively during public health emergencies (PHEs).

While the flexibility provided by the EUA procedure can and has saved lives, aspects of the procedure can also exacerbate public mistrust in the safety, rigor, and objectivity of FDA review and authorization. Focusing solely on drugs and vaccine EUAs, this Note builds off of existing scholarship to propose three modifications to the EUA procedure: (1) the EUA procedure should mandate that the FDA create and disseminate guidance as soon as practicable after the declaration of a PHE; (2) Congress should modify the evidentiary standard for vaccine EUAs; (3) the EUA procedure should mandate that the FDA cite, in the authorization letter, the evidence it relies upon when deciding to issue an EUA and publicly release any data and studies that underlie its decision. These modifications could yield pragmatic and positive reform without unduly sacrificing the speed and centralized authority the FDA needs to respond effectively to a PHE.

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