LAUSR

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 The FDA’s decision sparked immediate criticism.1 A group of 51 advocacy organizations wrote a letter to the chief executive officer of Gilead calling the designation an “unconscionable abuse” of orphan drug policy.2 Perhaps due to the intense public backlash, Gilead asked the FDA to revoke the orphan drug designation just 2 days after it was granted.3 In our view, the orphan drug designation for remdesivir was inconsistent with the purpose of the Orphan Drug Act. This designation also highlights a loophole in orphan drug policy that could be used again.