Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords.

Autor:	Bhimraj A; Department of Infectious Diseases, Cleveland Clinic, Cleveland, Ohio, USA., Morgan RL; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada., Shumaker AH; VA Northeast Ohio Healthcare System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA., Lavergne V; Department of Pathology and Laboratory Medicine, Vancouver General Hospital, Vancouver, British Columbia, Canada., Baden L; Brigham and Women's Hospital, Boston, Massachusetts, USA., Cheng VC; Department of Microbiology, Queen Mary Hospital, and Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China., Edwards KM; Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Gandhi RT; Infectious Diseases Division, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA., Gallagher JC; Department of Pharmacy Practice, Temple University, Philadelphia,PennsylvaniaUSA., Muller WJ; Division of Pediatric Infectious Diseases, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., O'Horo JC; Division of Infectious Diseases, Joint Appointment Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota, USA., Shoham S; Johns Hopkins University School of Medicine, Baltimore, Maryland, USAand., Wollins DS; Infectious Diseases Society of America, Arlington, Virginia, USA., Falck-Ytter Y; VA Northeast Ohio Healthcare System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2022 May 03; Vol. 74 (9), pp. 1686-1690.
DOI:	10.1093/cid/ciab880
Abstrakt:	Given the urgent need for treatments during the coronavirus disease 2019 pandemic, the US Food and Drug Administration issued emergency use authorizations (EUAs) for multiple therapies. In several instances, however, these EUAs were issued before sufficient evidence of a given therapy's efficacy and safety were available, potentially promoting ineffective or even harmful therapies and undermining the generation of definitive evidence. We describe the strengths and weaknesses of the different therapeutic EUAs issued during this pandemic. We also contrast them to the vaccine EUAs and suggest a framework and criteria for an evidence-based, trustworthy, and publicly transparent therapeutic EUA process for future pandemics. (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
Databáze:	MEDLINE
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