Advocacy Group Calls for Rescinding Remdesivir’s Approval as COVID-19 Treatment

Public Citizen is urging the FDA to convene an expert panel to discuss rescinding approval for Gilead Sciences’ Veklury (remdesivir) as a COVID-19 treatment.

The advocacy group argues that the agency made a mistake when it failed to refer Gilead Sciences’ New Drug Application for remdesivir to the FDA’s Antimicrobial Drugs Advisory Committee before granting the antiviral full approval on Oct. 22, 2020.

“The FDA’s previous failure to convene its own public advisory committee to consider whether to approve remdesivir was inexcusable,” said Michael Abrams, lead author of a letter sent Wednesday by the group to Acting Commissioner Janet Woodcock and Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

“This failure is particularly troubling given that the agency was aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit,” Abrams said, referencing a World Health Organization (WHO) study that found no evidence of the drug’s efficacy in treating COVID-19 (DID, Nov. 23, 2020).

The FDA granted remdesivir Emergency Use Authorization in May 2020 and there was no need to rush full approval and forgo seeking feedback from independent experts, the advocacy group said, noting that the agency convened advisory panels for COVID-19 vaccines that remain authorized for emergency use.

 “The main beneficiary of the highly debatable decision to approve remdesivir seems to be Gilead Sciences, which presently is earning massive, monopoly-protected profits thanks to the premature full approval by the FDA,” Public Citizen said.

Gilead reported global remdesivir sales of $2.8 billion in 2020. The company did not respond to a request for comment.

Read the Public Citizen’s letter to the FDA here: www.fdanews.com/04-21-21-PublicCitizenLetter.pdf. ― Jason Scott