US Food and Drug Administration (FDA) Emergency Use Authorization: Glass Half Full or Glass Half Empty
Clinical Trials | Health Services Administration | Infectious Disease | Pharmacy Administration, Policy and Regulation | Virus Diseases
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 More caution should have been taken based on what was learned from the recently rescinded EUA of hydroxychloroquine and chloroquine debacle which was approved initially based on an anecdotal report.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.
emergency use authorization, convalescent plasma, public trust, randomized control trial, COVID-19
DOI of Published Version
Guharoy R, Krenzelok EP. FDA Emergency Use Authorization: Glass Half Empty? Clin Infect Dis. 2020 Oct 26:ciaa1653. doi: 10.1093/cid/ciaa1653. Epub ahead of print. PMID: 33104216; PMCID: PMC7665427. Link to article on publisher's site
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Guharoy R, Krenzelok EP. (2020). US Food and Drug Administration (FDA) Emergency Use Authorization: Glass Half Full or Glass Half Empty. Open Access Publications by UMMS Authors. https://doi.org/10.1093/cid/ciaa1653. Retrieved from https://escholarship.umassmed.edu/oapubs/4400