The investigational drug remdesivir will be distributed according to a plan approved by the White House Coronavirus Task Force, according to the Federal Emergency Management Agency.
The maker of the drug, Gilead Sciences, had previously said the federal government would decide where to send the company’s existing supply – which is enough to treat between 100,000 and 200,000 patients.
“Remdesivir will be distributed directly to counties in the United States by the commercial provider – based on an allocation plan approved by the White House Task Force,” a FEMA spokesperson told CNN on Monday.
“FEMA and HHS are working on the longer term allocation strategy for this medical commodity,” the spokesperson added, referring to the US Department of Health and Human Services.
In early results from a trial sponsored by the National Institutes of Health, remdesivir was found to shorten the duration of illness in patients with severe Covid-19, but it had no statistically significant effect on whether patients died.
Gilead’s chairman and CEO, Daniel O'Day, said on CBS’s “Face the Nation” this weekend that the federal government would begin shipping "tens of thousands" of courses of remdesivir early this week.
The US Food and Drug Administration authorized remdesivir for emergency use last week in patients with severe Covid-19. Gilead has long said it would donate its existing supply of 1.5 million vials – enough to treat up to 200,000 people, according to O’Day.
"What we will do is provide that donation to the US government, and they will determine, based upon things like ICU beds, where the course of the epidemic is in the United States. They will begin shipping tens of thousands of treatment courses out early this week and be adjusting that as the epidemic shifts and evolves in different parts, in different cities here in the United States," O'Day said on Sunday.
His comments echo the FDA's emergency use authorization for the drug, which says: "Distribution of the authorized remdesivir will be controlled by the United States (U.S.) Government for use consistent with the terms and conditions of this EUA."
Asked for clarification on whether all 1.5 million vials would be donated to the US government, as O'Day suggested, Gilead spokesperson Sonia Choi said on Sunday that the company plans to provide the drug globally.
"We intend to allocate our available supply based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment,” she said.
“We are working with regulatory authorities worldwide and bioethicists to help inform our global allocation approach.”
In a statement on Friday, Gilead said its goal is to produce at least 500,000 treatment courses by October and more than a million by December.