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Birx to help lead remdesivir distribution effort as hospitals struggle to access drug

Since the drug was granted emergency use authorization, doctors have been left with no clear path to get it.
Image: The spread of the coronavirus disease (COVID-19) in Hamburg
A sealed glass capsule of remdesivir during a news conference at the University Hospital Eppendorf in Hamburg, Germany, on April 8, 2020.Ulrich Perrey / Pool via Reuters

Dr. Deborah Birx has been tapped to help manage the distribution of remdesivir to hospitals nationwide, the White House said Friday, amid growing frustration among physicians who say they have been unable to access the drug for their sickest COVID-19 patients.

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Birx — a key member of the White House's coronavirus task force — is the person "who's constantly reviewing the numbers, constantly reviewing the data," White House press secretary Kayleigh McEnany said during a briefing Friday. "She really has the best grasp as to how that should be distributed, so she will be one of the chief consultants."

A week ago, the Food and Drug Administration issued an emergency use authorization for remdesivir after preliminary evidence found the drug cut the time patients had to spend in the hospital from 15 days, on average, to 11.

The FDA's authorization specified the unapproved drug could be used for severely ill adults and children hospitalized with suspected or confirmed COVID-19 diagnoses who have low blood oxygen levels or who are on a ventilator.

The move was intended to increase physicians' access to remdesivir, which is not a cure, but is the only treatment so far to have shown a moderate impact on the illness.

But doctors were left with no clear pathway to access the drug for their patients.

"We've tried to reach out to the company to get remdesivir various times, but we haven't been successful," Dr. Michael Bell, head of critical care medicine at the Children's National Hospital in Washington, D.C., told NBC News. Bell said his patients have since recovered without the drug.

Gilead Sciences, which developed and manufactures remdesivir, said the company plays no role in deciding which hospitals receive the drug under the emergency use authorization.

"The U.S. government — specifically, the Federal Emergency Management Agency (FEMA) with the assistance of Department of Health and Human Services' Assistant Secretary for Preparedness and Response (ASPR) — will coordinate the donation and distribution of remdesivir to hospitals in regions most heavily impacted by COVID-19," the company wrote in a statement.

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But as of Friday morning, many physicians were unable to get the drug through the usual channels in the federal government, either.

"We have no idea how to request the drug. There's no public information about the process. And we don't know how the drug is being distributed to hospitals," said Dr. Michael Ison, a professor in the division of infectious disease and organ transplantation at Northwestern University Feinberg School of Medicine in Chicago.

Northwestern had not been granted use of the drug as of Friday afternoon. It was the same situation at Johns Hopkins Medicine in Baltimore.

"It's okay for a central entity in the federal government to be making these scarce resource allocation determinations," Lauren Sauer, director of operations for the Johns Hopkins Office of Critical Event Preparedness and Response, said. "The problem is there's no visibility at all on how the determination is being made."

The opaque process has made it difficult to explain to patients why they are unable to try remdesivir, she added.

"On top of that, it makes it hard for us to run and design clinical trials, knowing that there is a treatment that could be used as a standard-of-care arm, but we don't have access to it," she said.

A FEMA spokesperson told NBC News Friday afternoon that the drug was initially sent to seven states on Tuesday. "After consultation with health experts," the spokesperson wrote in an email, "HHS will be managing distribution of the next tranche of the treatment, based on urgent need."

Other than the White House announcement Friday suggesting that Birx would help oversee distribution of remdesivir, there was no word on how that process would be improved.

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