FDA: Release Research Data on Remdesivir for Emergency Use for Coronavirus Patients

Public Needs to Know the Strength of the Evidence Supporting FDA’s Action

WASHINGTON, D.C. – The U.S. Food and Drug Administration should promptly release all research data supporting Gilead Sciences’ request for emergency use of remdesivir for treatment of patients hospitalized with the coronavirus infection (COVID-19), Public Citizen said today in a Freedom of Information Act (FOIA) request to the agency.

Tens of millions of Americans are susceptible to severe COVID-19 infection and potentially eligible for emergency use of remdesivir in the future. Therefore, there is an urgent need for the public to be informed about the data regarding the safety and efficacy of remdesivir on which the FDA relied in granting Gilead Sciences’ EUA request for the drug, the FOIA request stated. The agency granted an Emergency Use Authorization (EUA) request for the drug on May 1.

“The American people need to be confident that the FDA’s decision was based on sufficiently rigorous preliminary scientific evidence especially given the constant pressure from the White House on the FDA to cut corners and rush the development of medical products for COVID-19,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The immediate release of data sought in our FOIA request is clearly in the public interest.”

In a separate letter to Gilead, Public Citizen is also asking Gilead to either consent to the FDA’s release of the information sought in the organization’s FOIA request or release the information itself.

Read the FOIA request here.

Read the letter here.