- After a week of confusion and criticism, the Trump administration over the weekend said states would take the lead in allocating to hospitals supplies of Gilead's COVID-19 drug remdesivir, which was recently shown in a clinical trial to hasten recovery from the disease caused by the new coronavirus.
- Remdesivir was cleared for emergency use by the Food and Drug Administration on May 1. But in the days following that green light, hospitals and physicians were left in the dark over how the antiviral drug would be distributed across the country, sparking frustration over the lack of transparency.
- Saturday's disclosure by an office within the U.S. Department of Health and Human Services offered some details — revealing 12 states had received, or will soon receive, vials of remdesivir — but left unclear why several states with high counts of COVID-19 cases received no supplies. HHS also said state health agencies would decide which specific hospitals are allotted remdesivir, seemingly contradicting initial reports.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a leading figure in the U.S. pandemic response, has called Gilead's remdesivir the new standard of care for COVID-19, citing positive results from a study his agency ran.
The reported benefit from the NIH study, along with the lack of other effective treatments for the disease, make the distribution of remdesivir a matter of intense urgency to hospitals strained by rising numbers of cases.
But for days after the FDA's emergency authorization on May 1, it wasn't clear which agency in the federal government was in charge of directing drug shipments. Nor was it apparent how decisions on which institutions would get the drug were being made.
Some hospitals with high numbers of admitted COVID-19 patients, including Boston Medical Center in Massachusetts and the University of California San Francisco, received no drug doses and were left wondering why, as detailed by STAT and CNN.
Apparently the Remdesivir has been distributed. @the_bmc got none. We have the second highest absolute case count and highest per bed in Boston. We also had no access to early trials. Today, the family of a dying patient asked me why we do not have RDV. What am I supposed to say?— Benjamin P. Linas (@BenjaminLinas) May 6, 2020
The federal government usually isn't in charge of sending drugs across the country. The emergency authorization granted to remdesivir by the FDA, however, specified distribution would be decided by the U.S. government rather than Gilead, which is donating its current supply of the therapy.
Saturday's statement from HHS shed some light on which states were receiving remdesivir and how much, but put the responsibility for determining which hospitals are supplied on state health agencies. New York, New Jersey, Illinois and Massachusetts have received most of the initial shipments, some 41,000 vials of the nearly 50,000 vials HHS confirmed it had sent or is in the process of sending to states.
No information was given on how future shipments would be allocated to the 38 states that have not yet received remdesivir, nor on why hard-hit states like California, Texas, Florida and Louisiana were left off the list for the first waves of distribution.
HHS said it expects remdesivir will be delivered to all 50 states, as well as territories, the Veterans Health Administration and the Indian Health Service.
Gilead currently has on hand 1.5 million vials of remdesivir, enough to treat some 140,000 people if the drug's standard 10-day treatment regimen is used. A clinical study run by Gilead suggested a 5-day course is equally effective, potentially allowing supplies to be extended further.
The drugmaker is donating all of its supply and HHS said Saturday the U.S. would receive about 40% of that stockpile, some 607,000 vials, over the next six weeks.
Gilead is working to massively ramp up drug production and expects to have 1 million treatment courses available by the end of this year. But with COVID-19 cases still climbing in many U.S. states, there could be shortfalls in supply running throughout the summer, according to estimates from investment bank RBC Capital Markets.
By giving away its existing stockpile, Gilead has bought time to figure out how it will price and distribute remdesivir after donated supplies run out. The drugmaker will eventually need to disclose its plans, which could become a flashpoint for a company that's come under fire for pricing life-saving hepatitis C and HIV drugs steeply.
Thus far, Gilead has only said it's focused on ensuring patients worldwide can access the drug.
The Federal Emergency Management Agency previously handled shipping donated doses of hydroxychloroquine to states for use in treating COVID-19, but it doesn't appear to be taking an active role with remdesivir. A FEMA spokesperson referred questions from BioPharma Dive to HHS.
On Friday, the White House indicated Deborah Birx, the coordinator of the U.S. coronavirus task force, would be in charge moving forward.
"She is going to be working and consulting as to where this drug should go," said White House Press Secretary Kayleigh McEnany, in a Friday press briefing. "She's the person who's constantly reviewing the numbers, constantly reviewing the data."
In the study run by NIAID, treatment with remdesivir shortened the time to recovery for patients hospitalized with COVID-19 by a median of about 4 days compared to placebo. Detailed information from the trial, however, has yet to be published.
HHS said candidates for donated doses of remdesivir must be on breathing support like mechanical ventilation or supplemental oxygen. Federal experts in public health have been in contact with state health departments to help in their allocation decisions, HHS said.
Initial distribution of remdesivir vials by U.S. government
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SOURCE: Department of Health and Human Services