Gilead Sciences Won’t Surrender Priority Review Voucher Gained From Remdesivir Approval

Gilead Sciences says it has no plans to relinquish the Priority Review voucher it earned from the FDA’s approval of remdesivir as a COVID-19 treatment despite urging from a consumer advocacy group that argued the company is earning more than is reasonable from the antiviral.

Public Citizen wrote to Gilead CEO Daniel O’Day on Monday, urging him to give up the Priority Review voucher the company was granted under the FDA’s material threat countermeasure Priority Review voucher program. The advocacy group argued that the drugmaker doesn’t need the voucher, given the enormous profit it has already made and stands to continue earning from its antiviral remdesivir, the first and only FDA-approved COVID-19 drug to date. The drug is priced at $520 per dose for private U.S. insurers and $390 per dose for the government.

“The [voucher] represents an entirely unnecessary and inappropriate incentive, given Gilead’s expected revenues,” Public Citizen contended. “In the third quarter of 2020, [Gilead’s] remdesivir revenues totaled $873 million. Wall Street analysts project Gilead will receive nearly $1 billion more in the fourth quarter and forecasted this summer that remdesivir sales could reach $7.7 billion in 2022.”

Priority Review vouchers are awarded as an incentive for developing certain types of drugs, for example, for rare pediatric diseases that don’t affect large portions of the population, and they can be used by drugmakers to receive faster FDA review times or can be sold to other companies for large amounts of cash.

But a Gilead spokesperson told FDAnews it won’t be transferring the voucher, instead implying that the company will use it to speed up FDA review of a product in its own pipeline. It did not address the issue of remdesivir profits.

“While the [voucher] is transferable, Gilead does not intend to sell the voucher, given the many investigational compounds in our pipeline that we believe have the potential to transform the treatment of serious diseases for individual patients and to advance global health,” the spokesperson said.

Read Public Citizen’s letter here: www.fdanews.com/11-03-20-Letter.pdf. — James Miessler