AGs Lead Charge to Increase Access, Affordability of Remdesivir

August 10, 2020 - A bipartisan multistate coalition recently called on HHS, the National Institutes of Health (NIH), and FDA urging them to use their authority to increase the availability of remdesivir.

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California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry led the coalition.

“During this unprecedented crisis, we must use every possible resource and tool available to save the lives of Americans who are falling ill from COVID-19,” said Becerra.

“With coronavirus cases rising across the nation, our leaders must step up and do what is best for the people. We cannot afford to leave the supply of this critical medication to chance and the whims of the marketplace when it was funded in part by taxpayer dollars. It is time for the Trump Administration to work with our bipartisan coalition of states to help increase the availability and affordability of Remdesivir.”

Remdesivir, a lead COVID-19 drug, is an FDA fast-tracked antiviral produced by Gilead with federal funding and expertise from the CDC.

Despite this support, the company has been unable to assure a supply of Remdesivir sufficient to alleviate the health and safety needs of the country amid the pandemic.

“Its supply is dangerously limited and its recent announcement of high prices for all patients, governments, and insurers will impede access to treatment in the US and further strain state budgets,” the coalition said in the letter.

“Therefore, we respectfully urge the federal government to exercise its rights under the Bayh-Dole Act, which will allow the National Institutes of Health (NIH) and the FDA to ensure that Americans can afford and access a sufficient supply of remdesivir during this pandemic,” the group urged.

According to a Gilead press release, the company plans to make 2 million treatment courses by the end of this year, which is between 12 million to 20 million vials.

But despite the company’s efforts to scale up its production capacity, Gilead’s production projection remains low and insufficient to handle the current demands or future demands.

Healthcare stakeholders have also criticized Gilead’s price tag for the COVID-19 treatment.

A recent study found that remdesivir can be manufactured at $0.93 per day or $12.50 per patient. But in June, Gilead announced that the company will charge government programs $2,340 for a six-vial, five-day treatment course.

Essentially, Gilead will charge 33 percent more for the same treatment, researchers said.

The coalition voiced their concern for this pricing issue, noting that it is “unfortunate” that Gilead chose to place its profit margins over the interests of Americans suffering during the pandemic.

Under the Bayh-Dole Act, the NIH and FDA have the authority to license remdesivir to third party manufacturers to scale up production and distribution and ensure the drug is made available to anyone at an affordable price.

But if these agencies are unwilling to increase the availability, the states requested that the agencies assign this authority for the states to use.

“The American public needs the support of the federal government in helping them afford COVID-19-related treatment. This is not the time for any company to extract large corporate profits from uninsured and underinsured Americans—nor can we allow the individual market priorities and weaknesses of one company to determine the fates of hundreds of thousands of people. Gilead should not profit from the pandemic and it should be pushed to do more to help more people,” they said.

“Alongside either exercise, we urge you to make full and immediate use of your legal authority under the Defense Production Act to put the weight of the federal government behind a rapid scaling up of remdesivir production and distribution.”