Gilead should give up FDA voucher for remdesivir, patient advocates say

Advocacy group Public Citizen wrote to Gilead asking it to give up a voucher given to it by the FDA when granted approval for remdesivir, arguing that the voucher is “an entirely unnecessary and inappropriate incentive” for the drug, which has already generated millions of dollars for the drugmaker. 

The FDA gave Gilead a priority review voucher when it approved remdesivir for use in treating COVID-19 patients, and the voucher gives Gilead the opportunity for accelerated FDA review time for another drug or to sell the voucher to other drugmakers. The voucher can be worth $100 million or more, STAT reported. 

The FDA said it gave Gilead the voucher for developing a drug to combat a virus that posed a “material threat” to public health. But Public Citizen argues Gilead doesn’t deserve the voucher because remdesivir has shown limited effectiveness and it already stands to generate billions of dollars for the drugmaker. 

“Lawmakers’ intent in creating the medical countermeasure [voucher] program was to provide additional incentives to pharmaceutical manufacturers to encourage development of new drug and biological medical countermeasures. Gilead is already being handsomely compensated through remdesivir sales and is slated to recoup any investment it made in its development many times over,” the group wrote to Gilead CEO Daniel O’Day. 

In the last week of October, Gilead reported that remdesivir generated $873 million in sales in the third quarter of this year, which boosted Gilead’s overall revenue by 17 percent from last year. 

Public Citizen also said U.S. taxpayers have contributed more than $70 million in support for remdesivir research and development, and Gilead is charging the U.S. the highest price for the drug out of all other countries. 

Gilead wrote to STAT, saying that “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.”

Read Public CItizen’s full letter here.

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