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ANN ARBOR, MI – Today, Representatives Debbie Dingell (D-MI) and Fred Upton (R-MI) asked the US Department of Health and Human Services to request additional information about the process and criteria used to distribute the federal government’s limited supply of the experimental drug remdesivir available for certain people with COVID-19. 

On May 1, the FDA made remdesivir available under an Emergency Use Authorization following preliminary clinical trial data from the National Institutes of Health. The Office of the Assistant Secretary and Response has coordinated distribution of the federal supply of remdesivir across the United States. 

Michigan Medicine was denied doses of remdesivir after applying to receive supplies for the treatment of patients hospitalized due to COVID-19. Michigan Medicine has treated more than 500 patients, including more than 80 current inpatients that are COVID-19 positive. 

“It’s deeply concerning that a leading medical research and provider such as Michigan Medicine was denied doses of remdesivir by the Administration,” said Dingell. “We need to ensure that hospitals around the country are able to access medicines so patients can recover from COVID. If leading educational hospitals don’t have access to doses, it indicates there may be a problem. Transparency in how the federal government’s current stockpile of remdesivir is being allocated is critical in providing certainty to providers and strengthening their ability to have a strong response to the coronavirus pandemic.”

“We know remdesivir has shown promising results for those severely infected by COVID-19, but we now we need to know if it is getting into the hands of those who need it most,” Upton said. “After there have been reports that hospitals in Michigan and elsewhere have had their requests for remdesivir denied, we are seeking additional information about the process for distributing this drug. We are in this fight together and all want the most effective treatment and care possible for patients. We need to ensure hospitals have every tool in the toolbox to make this happen.”

Dingell and Upton’s letter on the allocation of remdesivir is available here and below:

Dear Assistant Secretary Kadlec:

We are writing to request additional information about the process and criteria used to distribute the federal government’s limited supply of the investigational new drug remdesivir, which the U.S. Food and Drug Administration has indicated may benefit certain people in the hospital with COVID-19. 

Following preliminary clinical trial data from the National Institutes of Health indicating that remdesivir carries some clinical benefit to patients hospitalized due to COVID-19, the FDA authorized the use of remdesivir  under an Emergency Use Authorization (EUA) on May 1. After this EUA issuance, Gilead Sciences, the manufacturer of remdesivir, announced that the company would donate 1.5 million doses of the drug to the federal government. According to media reports, since this time, the your office has coordinated distribution of the federal supply of remdesivir across the United States. 

We are seeking information on how the drug is being allocated. Currently, hospitals and providers, including those in the State of Michigan, have been denied access to the drug without explanation. Clarity on the criteria used for distribution will allow providers to more effectively manage treatment of COVID-19 patients in the coming days and weeks. 

Transparency in the federal government’s role in allocation of remdesivir, and guidance on how remdesivir should be allocated, will provide certainty to providers and facilitate a stronger and more cohesive response to the COVID-19 pandemic. With this in mind, we are requesting additional information on the criteria used to decide where the 1.5 million doses of remdesivir are being distributed, as well as comprehensive data on which providers are receiving the drug and the amounts that they are receiving.

Thank you for your consideration of this request.