Abstract
BackgroundUnder Sect. 564 of the Federal Food, Drug, and Cosmetic Act, when the US Department of Health and Human Services Secretary issues a declaration based on one of four types of determinations, FDA may authorize an unapproved product or unapproved uses of an approved product for emergency use. It is unclear how much the public and health care providers understand about emergency use authorizations and how that understanding influences perceptions or behavioral intentions. The current study aimed to explore consumer and health care provider perceptions of emergency use authorizations and how promotion of emergency use authorizations has been investigated in the literature.MethodsWe conducted a scoping review via PubMed, Embase, Web of Science, and CINAHL for original research published in English from January 1, 2012, through November 10, 2022. We conducted surveillance of the literature through March 2023.ResultsWe identified 13 studies reported in 14 publications that addressed public and health care provider attitudes, understanding, and behaviors with regard to products authorized under an emergency use authorization. We did not identify any articles describing research regarding the promotion of emergency use authorization products. Findings suggest gaps in understanding of emergency use authorizations, both for the public and health care providers. Findings also suggest the public and health care providers have concerns about safety or the lack of full FDA approval that may contribute to decreased willingness to receive treatments and vaccines under an emergency use authorization.ConclusionsFuture research should explore how emergency use authorizations have been promoted and how that promotion impacts public and health care provider perceptions.
Published Version
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