State AGs Urge Government to Step in on Remdesivir Manufacturing

Almost three dozen state attorneys general have called on the federal government to bypass Gilead Sciences’ remdesivir patents and begin producing the COVID-19 treatment.

In a letter to the heads of the FDA, HHS and the National Institutes of Health, a bipartisan group of 34 state attorneys general urged the government to invoke its power under the Bayh-Dole Act to obtain rights to manufacture and price remdesivir.

The attorneys general contend that the government has the right to do this, as it has contributed millions in federal funding toward research of the antiviral, and they expressed concern over Gilead’s supply capabilities and its pricing.

 “Gilead is unable to assure a supply of remdesivir sufficient to alleviate the health and safety needs of the country amid this pandemic,” the AGs said. “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 U.S., and further strain state budgets.”

Gilead announced at the end of June that it will charge U.S. insurers $3,120 for a six-vial, five-day course of remdesivir, and $2,340 for governments of developed countries, including the U.S. (DID, June 30).

At the very least, the attorneys general said, the government should give the states the ability to use “march-in-rights,” which would give them the legal power to force Gilead to grant drug manufacturers licensing for the COVID-19 treatment.

They also called for the government to use its authority to rapidly scale up remdesivir production and distribution under the Defense Production Act, which gives the government powers to control domestic industry during times of emergency.

“Despite the company’s efforts to scale up its production capacity, Gilead’s production projection remains dangerously low and insufficient to handle the current domestic demands, let alone future demands for the antiviral drug,” they said.

Gilead did not respond to a request for comment.

Read the full letter here: www.fdanews.com/08-05-20-RemdesivirLetter.pdf. — James Miessler