key: cord-0935718-mxmiaigu
authors: Guharoy, Roy; Krenzelok, Edward
title: FDA’s commitment to transparency
date: 2021-02-18
journal: Am J Health Syst Pharm
DOI: 10.1093/ajhp/zxab053
sha: aa5508fcafa1ac26e21e3aea29c52c67bbdea7cf
doc_id: 935718
cord_uid: mxmiaigu

In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

monoclonal antibody that were granted between March 28 and November 9, 2020 with limited or no data to support those decisions. Two days after that FDA statement was issued, baricitinib, a janus kinus inhibitor in combination with remdesivir, was approved with only minimal data and no published data. 2 Five days after the FDA statement, a monoclonal antibody cocktail (REGN10933 and REGN10987) manufactured by Regeneron was granted an EUA, for treatment of mild to moderate COVID-19 in the outpatient setting, without peer-reviewed data. 3 Both National Institutes of Health and Infectious Diseases Society of America treatment guidelines for COVID-19 recommend against the routine use of monoclonal antibody because of very low certainty of evidence. 4, 5 It is puzzling that Regeneron was granted an EUA, further diminishing the credibility of the FDA.

While the EUAs provide clinicians access to potentially life-saving products, they may expose thousands of patients to questionable, ineffective, or harmful treatment and also rob potential recruitment for participation in randomized controlled trials (RCTs) to determine the appropriate use and safety of these novel treatments. In addition to HCQ, CP stands as a prime example of the failure of FDA's EUA process. Recently, two well-conducted RCTs that compared CP and placebo reported no significant differences in clinical status or mortality, while thousands of patients received CP under the FDA's compassionate use program. 6, 7 Request for an EUA by the manufacturers prior to the completion of large RCTs is short sighted, since the trials can be completed within a brief time due to the large number of patients during the global pandemic. The FDA needs to prove their true commitment to transparency and A c c e p t e d M a n u s c r i p t

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National Institutes of Health. Coronavirus disease 2019 (COVID-19) treatment guidelines

Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19

A randomized trial of convalescent plasma in Covid-19 severe pneumonia

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