Priority without progress: the FDA's neglected tropical disease voucher program after 18 years.

Introduction: To incentivize drug and vaccine development for neglected tropical diseases (NTDs), US Congress created the Priority Review Voucher (PRV) program in 2007. Sponsors that obtain Food and Drug Administration (FDA) approval for an eligible product receive a voucher redeemable to accelerate review of another product. Methods: We reviewed the program's public health impact by examining all 14 vouchers awarded for NTD products between 2007 and 2024, including the timing of FDA approval relative to World Health Organization (WHO) Prequalification, Essential Medicines List inclusion, first use in endemic countries, and voucher disposition. Results: Eight (57%) achieved WHO Prequalification, and 8 (57%) were listed in the Essential Medicines list. FDA approval occurred a median of 8.7 years after first regulatory approval or use in an endemic country and a median of 5.2 years after WHO Essential Medicines list inclusion. Conclusion: Our findings suggest that the PRV program has primarily rewarded regulatory filings for long-established therapies rather than stimulating innovation or improving access. We propose reforms linking voucher eligibility to equitable pricing and endemic country registration.