HHS Unveils Plan for Distributing Remdesivir

Following widespread criticism of the federal government’s handling of COVID-19 treatment remdesivir, HHS released details on Saturday of its distribution plan of the drug, and said states will make the final call on which hospitals get the drug.

HHS said state health departments will distribute the doses to appropriate hospitals “because state and local health departments have the greatest insight into community-level needs.”

Under the terms of the FDA’s Emergency Use Authorization issued on May 1, approving emergency use of the antiviral for patients with severe COVID-19, HHS was put in charge of distributing the drug. But it was another week and a day before HHS announced its distribution plan.

Criticism of the plan came swiftly online Saturday even after the federal government’s handling of donated remdesivir sparked outrage last week from physicians’ groups and doctors who called for fair allocations based on COVID-19 case data and hospitalization rates (DID, May 8).

On Saturday, Kyle Massey, a clinical pharmacist in Maine, criticized the process, noting that it did not discuss a timeline for the remaining vials of remdesivir to be distributed.

“Still clear as mud. I assume more information to come,” he said.

Rachel Sachs, a law professor at Washington University in Missouri, took issue with the plan because it left more questions than answers. For example, she noted that it is still unclear who in the administration is responsible for allocating the drug to states.

She asked online: Is the Assistant Secretary for Preparedness and Response who “announced” this plan in charge? Dr. (Deborah) Birx, as stated Friday? HHS Secretary Alex Azar?

“The refusal to take responsibility for the rollout is disappointing,” Sachs wrote.

A Pennsylvania physician, Walid Gellad, questioned via Twitter how a state health department could fairly allocate the drug without adequate data. For example, he said, a rural hospital may have patients on oxygen at high risk of progressing, and a big academic center with more advanced oxygenation equipment may have the same number of patients.

“Should it go equally to both? Might it help more in the rural hospital? We have no idea,” Gellad said.

Gilead Sciences, the maker of the drug, has committed to donating 607,000 vials of the antiviral to the U.S. over the next six weeks — part of the 1.5 million doses it committed to donating worldwide.

Cases containing 40 vials each were sent last week to seven states: New York (565 cases), Massachusetts (117 cases), New Jersey (94 cases), Indiana (38 cases), Rhode Island (30 cases), Tennessee (7 cases) and Virginia (33 cases).

Six other states are next in line for deliveries: Connecticut (30 cases), Illinois (140 cases), Iowa (10 cases), Maryland (30 cases), Michigan (40 cases) and New Jersey (110 cases), HHS said, adding that it expects all 50 states will receive some doses.

But before Saturday, Gilead was making side deals with some states apart from the government’s handling of the drug. It donated 1,600 doses to the state of Maryland. — Jordan Williams