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.
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).
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 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