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Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies

Educational Objective
To understand the importance of transparent and reliable evidence in emergency use authorizations for COVID-19 therapies
1 Credit CME

On March 28, 2020, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the use of hydroxychloroquine and chloroquine for certain hospitalized patients diagnosed with coronavirus disease 2019 (COVID-19).1 Hydroxychloroquine and chloroquine have long been approved for the prophylaxis and treatment of malaria, with the former also used in the treatment of systemic lupus erythematosus and rheumatoid arthritis. Although these drugs appear to inhibit coronavirus replication in vitro, at the time of the EUA, there was no reliable clinical evidence to support the use of these drugs to treat COVID-19 in patients.

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Article Information

Corresponding Author: Aaron S. Kesselheim, MD, JD, MPH, Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120 (akesselheim@partners.org).

Published Online: May 19, 2020. doi:10.1001/jamainternmed.2020.2402

Conflict of Interest Disclosures: Dr Kesselheim reported grants from Arnold Ventures and from the Harvard–MIT Center for Regulatory Science. No other disclosures were reported.

References
1.
US Food and Drug Administration. Request for emergency use authorization for use of chloroquine phosphate or hydroxychloroquine sulfate supplied from the strategic national stockpile for treatment of 2019 coronavirus disease. Published March 28, 2020. Accessed April 12, 2020. https://www.fda.gov/media/136534/download
2.
Project BioShield Act, Pub L No. 108-276, 118 Stat 835 (2004).
3.
US Food and Drug Administration. Emergency use authorization of peramivir IV: fact sheet for health care providers. Accessed April 12, 2020. https://www.fda.gov/media/77787/download
4.
US Food and Drug Administration. Fact sheet for health care providers: emergency use authorization (EUA) of hydroxychloroquine sulfate supplied from the strategic national stockpile for treatment of COVID-19 in certain hospitalized patients. Accessed April 12, 2020. https://www.fda.gov/media/136537/download
5.
Gautret  P , Lagier  JC , Parola  P ,  et al.  Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial.   Int J Antimicrob Agents. Published online March 20, 2020. doi:10.1016/j.ijantimicag.2020.105949PubMedGoogle Scholar
6.
Goodman  JL , Borio  L .  Finding effective treatments for COVID-19: scientific integrity and public confidence in a time of crisis.   JAMA. Published online April 16, 2020. doi:10.1001/jama.2020.6434PubMedGoogle Scholar
7.
Thomas  K . Trump calls this drug a “game changer.” Doctors aren’t so sure. New York Times. April 17, 2020. Accessed April 25, 2020. https://www.nytimes.com/2020/04/17/health/trump-hydroxychloroquine-coronavirus.html?searchResultPosition=2
8.
National Institutes of Health. COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Published April 21, 2020. Accessed April 21, 2020. https://www.covid19treatmentguidelines.nih.gov
9.
US Food and Drug Administration. FDA drug safety communication: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. Published April 24, 2020. Accessed April 25, 2020. https://www.fda.gov/media/137250/download
10.
US Food and Drug Administration. Request for emergency use authorization for use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients. Published May 1, 2020. Accessed May 1, 2020. https://www.fda.gov/media/137564/download
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