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On May 1, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for remdesivir for the treatment of hospitalized adults and children with severe coronavirus disease 2019 (COVID-19). An EUA permits the use of an unapproved drug, biologic, or medical device and may be issued by the FDA when the secretary of Health and Human Services has declared a public health emergency “that has a significant potential to affect national security or the health and security of United States citizens living abroad.”1 As seen with the FDA’s recent revocation of the EUA for hydroxychloroquine, the agency has wide discretion to revoke or revise EUAs when appropriate for public health (the FDA does not have comparable authority to act so quickly with respect to drugs that have been approved).
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Corresponding Author: Ameet Sarpatwari, PhD, JD, Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120 (email@example.com).
Published Online: June 24, 2020. doi:10.1001/jama.2020.11932
Conflict of Interest Disclosures: Ms Kaltenboeck reported receiving personal fees from AstraZeneca and SVB Leerink, a grant from Kaiser Permanente outside the submitted work, and serving on the Advisory Committee for the ICER report on drug price increases without supporting clinical evidence. No other disclosures were reported.
Funding/Support: Dr Sarpatwari and Dr Kesselheim’s work was supported by Arnold Ventures and the Harvard-MIT Center for Regulatory Science. Ms Kaltenboeck’s work was supported by Arnold Ventures.
Role of the Funder/Sponsor: Arnold Ventures and the Harvard-MIT Center for Regulatory Science had no role in the preparation, review, or approval of the manuscript or decision to submit the manuscript for publication.
Additional Contributions: We thank Jerry Avorn, MD (PORTAL), and Patricia J. Zettler, JD (The Ohio State University Moritz College of Law), for their comments on an earlier draft.
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