On March 23, 2020, the US Food and Drug Administration (FDA) granted Gilead Science an orphan drug designation for remdesivir to treat coronavirus disease 2019 (COVID-19), even though this status is usually reserved for drugs that treat rare diseases.1 In explaining its decision, the agency stated that at the time of Gilead’s application for designation, there were sufficiently few confirmed cases of COVID-19 in the United States that remdesivir met criteria for designation under the Orphan Drug Act of 1983.1
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Kao-Ping Chua, MD, PhD, Department of Pediatrics, University of Michigan, 300 N Ingalls St, SPC 5456, Rm 6E18, Ann Arbor, MI 48109-5456 (firstname.lastname@example.org).
Published Online: August 17, 2020. doi:10.1001/jamainternmed.2020.2759
Conflict of Interest Disclosures: None reported.
Funding/Support: Dr Chua is supported by a career development award from the National Institute on Drug Abuse (grant number 1K08DA048110-01). Dr Conti is supported by a grant from the American Cancer Society.
Role of the Funder/Sponsor: The funders had no role in the creation of this article; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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