Inquiry comes after reports of a chaotic initial rollout.
Lawmakers are pressing the Trump administration for data about how officials are distributing remdesivir, the only drug approved thus far to treat the novel coronavirus.
Since the Food and Drug Administration issued emergency use authorization for the drug on May 1, doctors, hospitals and lawmakers have been raising questions about where the much sought after drug is going and based on what criteria. On Wednesday, 13 Senators—one Independent and 12 Democrats—asked Health and Human Services Secretary Alex Azar to explain how the federal government is distributing the drug.
“We acknowledge that the limited current supply and substantial demand for remdesivir results in necessary choices about distribution. However, in the midst of this pandemic, it is unacceptable for our health care system and patients to be left in the dark,” the lawmakers wrote. “Given the likelihood of future therapeutics and vaccines being approved or authorized for use in the U.S., it is essential that the administration assuage concerns about this initial test run of such federal distribution.”
Doctors and hospitals nationwide criticized the administration’s “uneven and opaque” way of initially distributing remdesivir, Stat News reported on May 6. Clinicians told the outlet they were not sure why some medical facilities were selected to receive the drug while others were not.
On May 11, The Wall Street Journal reported that Dr. Deborah Birx, White House coronavirus response coordinator, said in an email on May 7 that the administration’s initial distribution of remdesivir was flawed. “Hospitals were told they would be notified directly by AmerisourceBergen Corp., a drug wholesaler that is distributing the drug on behalf of the federal government, if they were chosen to receive remdesivir,” said the paper. “Hospitals said they were not informed why certain hospitals were chosen and others weren’t, and complained that shipments were failing to reach those who needed the drug most.”
Two days after Birx reportedly sent the email to coronavirus task force members, the Health and Human Services Department issued a statement saying that states will now get the drug and then distribute it to hospitals based on their needs.
“With a sense of urgency to get doses to hospitalized patients, it has been determined that state health departments have the greatest insight into which hospitals in their states have the greatest number of COVID-19 patients meeting the criteria for use of remdesivir under the Emergency Use Authorization,” a HHS spokesperson told Government Executive on Thursday. “State health departments have worked with hospitals on strategies for caring for COVID-19 patients within their states, and will be working with hospitals on distribution of the limited supply of donated remdesivir. Gilead is using its distributor to deliver the donated remdesivir to state health departments.”
The senators asked Azar for a briefing by May 19 from administration officials involved in the allocation process to “ensure equitable distribution” of the drug. They also asked for the relevant agencies to create a public-facing portal to showcase their selection methodology and establish a process for hospitals to request remdesivir. The $2.2 trillion CARES Act, enacted in late March, provided funding to address drug supply shortages and expedite the approval process.
“We have received a number of letters from Congress on COVID-19, and the department is working to respond,” said the HHS spokesperson. “We continue to maintain an open line of communication with members of Congress, including briefings for members of both the House and Senate, while helping coordinate the response to the public health emergency.”
The distribution of remdesivir also came up during Dr. Rick Bright’s testimony before a House subcommittee on Thursday. Bright, who was ousted from his position as director of the Biomedical Advanced Research and Development Authority in April, filed a whistleblower complaint with the Office of Special Counsel that alleged, among other things, he was involuntarily transferred to a lower position following his protected disclosures about the administration's push to use an unproven malaria-drug to treat the coronavirus.
Rep. Raul Ruiz, D-Calif., noted that in his complaint, Bright warned about potential shortages of remdesivir over three months ago following preliminary reports that the drug could help patients recover from coronavirus.
“We would have had a plan,” said Bright, when asked if he thinks the transparency issues could have been avoided if HHS officials listened to him. “We should have had a plan for that drug and any other drug in limited supply.”