Federal Government to Control Remdesivir Distribution

HHS and FEMA will control the distribution of Gilead’s remdesivir as a COVID-19 treatment as a condition of its Emergency Use Authorization (EUA) by the FDA.

Gilead CEO Daniel O’Day said the government will begin shipping “tens of thousands” of treatment courses as early as this week, and distribution will be adjusted as the epidemic shifts across the U.S.

Under the EUA, Gilead will supply remdesivir directly to government agencies or distributors, which will then supply the drug to hospitals and other healthcare facilities as directed by the government. Gilead has not yet set a price for the drug, which received an EUA from the FDA on May 1 (DID, May 4).

The Institutes for Economic and Clinical Review (ICER) estimates that Remdesivir would need to cost no more than $4,500 for a 10-day COVID-19 treatment to be cost-effective.

Gilead is under intense pressure to keep the drug’s price as low as possible. Reps. Lloyd Doggett (D-Texas) and Rosa DeLauro (D-Conn.) wrote to HHS Secretary Alex Azar asking how much the government spent on research and development for remdesivir and how HHS will ensure that the drug is affordable.

“Taxpayers are often the angel investors in pharmaceutical research and development,” the lawmakers wrote. “Yet this is not reflected in the prices they pay.”

Read ICER’s initial report here: www.fdanews.com/05-04-20-ICERCOVIDInitialAbstract.pdf.

Read the lawmakers’ letter here: www.fdanews.com/05-04-20-Remdesivirinvestmentletter.pdf. — Jordan Williams