Gilead’s Virus Drug Donation Runs Out While Outbreak Deepens

The federal government’s supply of Covid-19 treatment remdesivir will run out by June 29, leaving hospitals worried about their supplies for the summer and fall.

The Department of Health and Human Services is “currently in conversations with Gilead Sciences, Inc. to determine how their anticipated inventory of 2 million doses by year’s end will be allocated and when,” a spokesperson told Bloomberg Law Thursday.

Remdesivir, orginally developed to treat Ebola, was one of the first drugs to get an emergency use authorization for Covid-19. The designation allows drugs to be used in ways not previously approved. The only other medicines with emergency authorizations are drugs to sedate patients in intensive care and to provide continuous renal replacement therapy for patients who need acute care during the pandemic, according to the Food and Drug Administration’s website.

Gilead has already donated its entire supply of remdesivir, according to a June 22 statement from CEO Daniel O’Day. That includes 1.5 million doses the company announced in May. The HHS Office of the Assistant Secretary for Preparedness and Response received two sets of donations and developed an allocation plan to ship the second donation in two batches, with the final shipment planned for June 29.

“Once they do that, with the exception of a very small amount that they’re setting aside for emergencies—but it’s very small—the entirety of the donated remdesivir will have been shipped,” Heather Pierce, senior director and regulatory counsel at the Association of American Medical Colleges, said. “The big question is what’s next?”

Hospitals fear there will be a supply gap in July and August. However, HHS officials have assured hospitals and states that additional doses will be available in July and they shouldn’t hoard the drug, Pierce said.

The HHS is keeping 2% of the donated drugs in reserve to respond to hot spots, according to the HHS website on its remdesivir allocation process.

But Pierce said that doesn’t answer whether the next batch will be donated or will need to be purchased.

“If it does move to a commercial mechanism, will they charge for it? Then the question is: how will it be allocated and will it still go through a central mechanism or not?” she asked. “Currently, the terms of the emergency use authorization require central federal government allocation of the drug. But it’s silent as to charging.”

Gilead expects to have more than 2 million remdesivir treatment courses manufactured by the end of the year “and many millions more by 2021,” O’Day said in his statement.

“We donated our entire existing supplies of remdesivir through June,” O’Day said, adding that the company has set up licensing agreements with nine generic manufacturers. “As we go forward, we will work to ensure that remdesivir is accessible and affordable to governments around the world. All of us at Gilead feel the full weight of our responsibility with remdesivir and this will continue to guide all our future actions.”