FDA Fixes Fee Fumble for Rare Disease Fast-Track Vouchers
Published Date: 7/28/2026
Notice
Summary
The FDA fixed some details about the fee for using a Priority Review Voucher in 2026. If you're submitting a drug application using one of these special vouchers, you now have to pay the fee right when you submit your application. This change affects companies working on rare pediatric diseases, tropical diseases, or medical countermeasures, and it kicks in starting February 3, 2026.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 1 costs, 1 mixed.
Priority Review Fee Due at Submission
If you are a sponsor using a priority review voucher for a rare pediatric disease, tropical disease, or material threat medical countermeasure, the priority review user fee must be paid when you submit the human drug application. This reflects the February 3, 2026 amendment to section 529 of the FD&C Act and applies to submissions under section 505(b)(1) or section 351(a).
Form FDA 3397 Voucher Selection Hold
Form FDA 3397 (Prescription Drug User Fee Coversheet) is updated to let sponsors select use of a rare pediatric disease priority review voucher. If you select a tropical disease, material threat MCM, or rare pediatric disease voucher on Form FDA 3397, the form will be placed on hold while FDA reviews the voucher redemption; after the hold is lifted you may complete the form and pay the fees.
Rolling Review Submission Date Clarified
For a "rolling review" application where a tropical disease, rare pediatric disease, or material threat MCM priority review voucher is redeemed, FDA will treat the application as submitted on the date FDA receives the final portion that the applicant identifies as complete. This follows FDA's May 2014 guidance on expedited programs.
Use Pay.gov Unique User Fee ID
For all priority reviews, sponsors must use the unique user fee ID number generated for the Pay.gov feature when making wire transfers or payments. This instruction replaces prior wording in the wire transfer payment process section.
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