Letter to the Hon. Robert Kadlec, Assistant Secretary of Health and Human Services - Upton, Dingell Urge Administration to Make Remdesivir Available to Michigan Health Care Providers

Letter

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.

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