FDA Emergency Use Authorization: Glass Half Empty?
Identifieur interne : 001307 ( Main/Exploration ); précédent : 001306; suivant : 001308FDA Emergency Use Authorization: Glass Half Empty?
Auteurs : Roy Guharoy ; Edward P. KrenzelokSource :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [ 1537-6591 ] ; 2020.
Abstract
Recently, the Food and Drug Administration (FDA) issued emergency use authorization (EUA) of convalescent plasma (CP) for the treatment of COVID-19 hospitalized patients based on a non-peer reviewed open label observational study. Issuance of an EUA without a proven randomized control trial (RCT) sets a dangerous precedent since the premature action drives health care providers and patients away from RCTs that are essential for determining the efficacy and safety of CP. More caution should have been taken based on what was learned from the recently rescinded EUA of hydroxychloroquine and chloroquine debacle which was approved initially based on an anecdotal report. The FDA approval process for determining efficacy and safety must be based solely on data from RCTs to sustain public and professional trust for future treatment or vaccine efforts to be successful.
DOI: 10.1093/cid/ciaa1653
PubMed: 33104216
PubMed Central: PMC7665427
Affiliations:
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Krenzelok</name><affiliation><nlm:affiliation>Pharmacy, University of Pittsburgh School of Pharmacy.</nlm:affiliation><wicri:noCountry code="subField">University of Pittsburgh School of Pharmacy</wicri:noCountry></affiliation></author></analytic><series><title level="j">Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</title><idno type="eISSN">1537-6591</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Recently, the Food and Drug Administration (FDA) issued emergency use authorization (EUA) of convalescent plasma (CP) for the treatment of COVID-19 hospitalized patients based on a non-peer reviewed open label observational study. Issuance of an EUA without a proven randomized control trial (RCT) sets a dangerous precedent since the premature action drives health care providers and patients away from RCTs that are essential for determining the efficacy and safety of CP. More caution should have been taken based on what was learned from the recently rescinded EUA of hydroxychloroquine and chloroquine debacle which was approved initially based on an anecdotal report. The FDA approval process for determining efficacy and safety must be based solely on data from RCTs to sustain public and professional trust for future treatment or vaccine efforts to be successful.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">33104216</PMID><DateRevised><Year>2020</Year><Month>11</Month><Day>17</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1537-6591</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Oct</Month><Day>26</Day></PubDate></JournalIssue><Title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</Title><ISOAbbreviation>Clin Infect Dis</ISOAbbreviation></Journal><ArticleTitle>FDA Emergency Use Authorization: Glass Half Empty?</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">ciaa1653</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1093/cid/ciaa1653</ELocationID><Abstract><AbstractText>Recently, the Food and Drug Administration (FDA) issued emergency use authorization (EUA) of convalescent plasma (CP) for the treatment of COVID-19 hospitalized patients based on a non-peer reviewed open label observational study. Issuance of an EUA without a proven randomized control trial (RCT) sets a dangerous precedent since the premature action drives health care providers and patients away from RCTs that are essential for determining the efficacy and safety of CP. More caution should have been taken based on what was learned from the recently rescinded EUA of hydroxychloroquine and chloroquine debacle which was approved initially based on an anecdotal report. The FDA approval process for determining efficacy and safety must be based solely on data from RCTs to sustain public and professional trust for future treatment or vaccine efforts to be successful.</AbstractText><CopyrightInformation>© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. 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