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Priority Review Voucher Fee Decreases For FY 2021 May Reflect US FDA Personnel Changes

 
• By Derrick Gingery

In part because assessment costs plummeted in FY 2019, the FY 2021 fee to redeem a priority review voucher will be 37% less than the previous year.

fee decrease
The FY 2021 priority review voucher user fee decreased more than 37% from the previous year. • Source: Shutterstock

Application assessments, among the most labor-intensive US Food and Drug Administration tasks, were substantially cheaper in fiscal year 2019, another indication that experience levels at White Oak may be shifting.

In its announcement of the FY 2021 tropical disease, rare pediatric disease, and material threat medical countermeasure priority review voucher fees, the FDA revealed the cost of...

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FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
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The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
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The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

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Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
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Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

More from Pathways & Standards

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
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The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
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The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
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