Early missteps, transparency questions dog U.S. government's remdesivir rollout: reports

remdesivir
As Gilead works to produce as much remdesivir as possible, an initial rollout handled by the U.S. government got off to a rocky start, according to reports. (Gilead)

When there’s only one proven therapy for a global pandemic that’s infected millions—and a limited initial supply—how exactly should officials distribute it? So far, the U.S. government hasn't figured it out, reports say. 

When Gilead Sciences scored its groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the federal government. But the rollout has gotten off to a rocky start, according to reports. 

The medicine—the only one so far to demonstrate positive controlled results against COVID-19—hasn’t gone to certain high-priority hospitals that needed it most, Axios reports. Instead, some remdesivir doses “went to the wrong places,” an unnamed senior Trump administration told the publication. 

The mistake, amid thousands of daily COVID-19 deaths in the U.S., angered top officials in the administration’s response team, according to the report. 

Since Gilead said it would donate its entire 1.5 million-dose supply last Friday, the administration has shipped about 32,000 doses to Indiana, Massachusetts, New Jersey, New York, Rhode Island, Tennessee and Virginia, Axios reports. Some doses went to “less impacted counties,” an official told the publication.

A communication breakdown between HHS and FEMA spawned the mistake, according to the report.

That 32,000-dose distribution wave is only a small portion of the 1.5 million doses Gilead will make available for distribution nationwide. 

RELATED: Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says 

Meanwhile, hospital administrators say the government has rebuffed their requests for the drug, the Wall Street Journal reports. Facilities in Seattle, Chicago and Providence, Rhode Island—including some that participated in remdesivir trials—say they can't get the therapy for their patients, and they're demanding clarity about where the vials are going and how the allocation decisions are made.

Hospital administrators aren't alone. Doctors and pharmacists also shared their own worries with CNN. As of Friday, there was no system they could use to apply for the drug on behalf of a patient.

Gilead’s remdesivir scored an FDA emergency use authorization late last week based on data showing it reduced COVID-19 patients’ recovery time by 31% compared with placebo. This week, Japan approved the drug under an “exceptional approval” regulatory pathway. Gilead’s distribution plans for Japan remain unclear, and a spokeswoman didn’t immediately respond to a request for comment. 

RELATED: Gilead, working on its own remdesivir ramp-up, scouts licensing partners for global production 

Even as Gilead works to increase its own supply of the medicine, the company is in licensing talks with some of the “world’s leading chemical and pharmaceutical manufacturing companies” about their ability to produce remdesivir for countries in Europe, Asia and beyond until at least 2022.

The company is discussing licensing the med to generics makers in India and Pakistan to supply patients in developing countries. It's also considering licensing the drug to the Medicines Patent Pool and exploring using UNICEF’s expertise for distribution in low- and middle-income countries. 

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