California AG Wants More Companies to Be Able to Make COVID-19 Drug

KQED Science News

Doctors say the antiviral drug remdesivir is one of the few treatments that benefits patients hospitalized with COVID-19. But the drug, made by Gilead Sciences, can cost more than $3,000 for the full course of treatment, and some hospitals — including several in the Bay Area — say it’s in short supply.

Foster City-based Gilead is currently the only company making remdesivir, and AmerisourceBergen is the sole distributor.

On Tuesday, California Attorney General Xavier Becerra sent a letter to federal health officials, urging them to allow other companies to manufacture and distribute the drug.

The letter, which was addressed to top officials at the U.S. Department of Health and Human Services, the National Institutes of Health, and the federal Food and Drug Administration, was endorsed by a bipartisan coalition of 34 state attorneys general.

Gilead has announced plans to make 2 million courses of remdesivir, which can be either six or 10 vials, by the end of the year. Becerra’s letter calls that amount “dangerously low” to handle current or future coronavirus outbreaks.

He says now is the time to produce more of the drug.

“If Gilead is not prepared to do it,” he said, “We have the right to say we’re going to try to do whatever we can, go wherever we must, to ramp up the supply.”

No ‘Secret Sauce’

Because the development of remdesivir was supported in part by federal tax dollars, including a $30 million NIH-funded clinical trial, Becerra says there are legal grounds for Washington to intervene.

“It’s not as if there’s a secret sauce here,” Becerra told KQED. “Folks know how to make this drug and the taxpayers helped make that drug possible. Let’s get it out there to folks.”

Under the Bayh-Dole Act, the letter says, the federal government could make Gilead license its remdesivir patent to third party manufacturers.

An HHS spokesperson wrote in an email that because remdesivir wasn’t, “as a whole,” funded by the federal government, it doesn’t believe the Bayh-Dole Act applies in this case.

Gilead said in a statement it was “deeply disappointed” by the letter, and that it misrepresented the overall need for its drug:

“One significant factual error is the assertion that all 3.5 million current COVID-19 patients should be treated with remdesivir. This assertion ignores the fact that not all COVID-19 patients are eligible to be treated with remdesivir and, thankfully, many will recover prior to hospitalization and never need the drug.”

Remdesivir was shown in one controlled clinical trial to reduce median COVID-19 hospital stays by about four days.

Desperate Hospitals

Dr. Peter Chin-Hong, an infectious disease specialist at UCSF, says that on Tuesday the hospital was down to two vials of remdesivir, with another shipment expected, but not guaranteed, to arrive soon.

Chin-Hong says local hospitals have sent each other vials of remdesivir, when able, so that their COVID-19 patients can get the treatment.

“We’re definitely desperate for the drug,” said Chin-Hong. “At the clinical end, health care providers currently in 2020 spend a disproportionate amount of time bartering [the] drug, sourcing the drug, trying to play remdesivir Tetris where we’re constantly figuring out, do we have enough?”

With the expectation of another coronavirus surge this winter, Chin-Hong says suppliers need to come together to make more remdesivir.

“The timing of the attorney general’s letter is actually perfect,” he said, “because if we decide to do something now, we could have an impact on that winter surge.”