Updated: Gilead collects 5th priority review voucher as public advocacy group urged the company to relinquish it
Gilead recently collected its 5th priority review voucher, this time for its megablockbuster Covid-19 drug remdesivir, which brought in $1.5 billion last quarter.
Many have questioned and critiqued the need for such lucrative vouchers, which can be used to speed another drug application by four months or sold for more than $100 million, particularly in instances where the products that are qualifying generate tens of billions annually.
For California-based Gilead, the vouchers have been piling up in recent years. This most recent PRV for remdesivir follows the company’s purchase of four PRVs in 2014, 2016, 2017 and 2018 for a total of $620 million.
And Gilead isn’t the first company to wait to collect its PRV for a Covid-related approval as BioNTech did the same for its PRV following the approval of its vaccine with Pfizer. The company did not explain why it waited but later published an Endpoints News story in an SEC filing on the matter.
Back in 2020, when remdesivir first won FDA approval, the nonprofit Public Citizen urged the company to relinquish its PRV, explaining how it “represents an entirely unnecessary and inappropriate incentive.
“U.S. government scientists likely coinvented remdesivir and U.S. taxpayers have provided more than $70 million dollars in support for remdesivir research and development, yet Gilead is charging American consumers $520 per dose – more than anyone else in the world,” Public Citizen’s Peter Maybarduk wrote.
Since then, remdesivir has brought in more than $8 billion for Gilead.
Gilead did not comment on why it collected the PRV recently but said in a statement:
FDA granted Veklury (remdesivir) a Material Threat Medical Countermeasure (MCM) Priority Review Voucher in recognition of Veklury’s eligibility as a treatment for SARS-CoV-2, which is considered a material threat against the US population by the Acting Secretary of Homeland Security. In line with FDA process, the priority review voucher has now been listed in the federal register by the FDA. Veklury is the antiviral standard of care for the treatment of people hospitalized with COVID-19 and is also recommended for use in those who do not require supplemental oxygen or hospitalization and are at an increased risk of progressing to severe COVID-19. The priority review voucher will enable Gilead to more rapidly advance an investigational treatment in our pipeline and reach patients in need.