By Deena Beasley
(Reuters) – The Infectious Disease Society of America (IDSA) is asking for more information on the federal government’s plan for deciding how and where to supply the only drug so far shown to help patients infected with the novel coronavirus.
The U.S. Food and Drug Administration on Friday gave emergency use authorization to Gilead Sciences Inc’s remdesivir for patients with severe COVID-19 – the disease caused by the coronavirus – clearing the way for broader use in more hospitals around the United States.
The federal government began distributing the drug this week. But doctors across the country, particularly in COVID-19 hotspots like New York and Boston, became concerned after being denied their request to obtain the new therapy, IDSA president Dr. Thomas File told Reuters on Thursday.
“Some are seeing other hospitals approved, but say ‘we have more cases than they do, so why were we turned down?’” he said.
The IDSA on Wednesday called on the Trump Administration to explain how it will ensure equitable distribution of remdesivir to states and hospitals based on COVID-19 case and hospitalization rates.
The physician group also stressed the importance of fair allocation to health facilities in communities disproportionately affected by the coronavirus, including African American and Hispanic populations.
The IDSA said it did not know how many hospitals had so far been authorized to receive remdesivir or how many had been turned down.
Gilead last week donated 1.5 million vials of the drug to U.S. hospitals, enough to treat at least 140,000 patients.
The Federal Emergency Management Agency (FEMA) and the Department of Health and Human Services (HHS) are coordinating the donation and distribution of remdesivir.
Hospitals with intensive care units “and other hospitals that the government deems most in need will receive priority,” Gilead said in an emailed statement.
Officials at FEMA and HHS did not immediately respond to requests for comment. AmerisourceBergen Corp, the exclusive distributor for the drug, said decisions on which hospitals and the quantity of product they will receive are being made by the government. Gilead’s donation “is likely to fall short of demand” for the drug throughout the summer, the IDSA said.
In a large clinical trial released last week, remdesivir was shown to speed recovery times of hospitalized COVID-19 patients compared to a placebo. Gilead announced on Thursday that the drug has been approved for use in Japan.
“We are working out the details of the allocation to Japan and do not have specifics to share at this time,” the company said in an email.
Reporting By Deena Beasley; Editing by Bill Berkrot.