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

Area of Science:

• Global Health
• Pharmaceutical Policy
• Drug Development

Background:

• The Priority Review Voucher (PRV) program was established by the US Congress in 2007 to incentivize the development of drugs and vaccines for neglected tropical diseases (NTDs).
• Eligible products approved by the Food and Drug Administration (FDA) grant sponsors a voucher for accelerated review of another product.

Purpose of the Study:

• To evaluate the public health impact of the PRV program for NTDs.
• To analyze the timing of FDA approval in relation to global health metrics and voucher utilization.

Main Methods:

• A review of all 14 vouchers awarded for NTD products between 2007 and 2024.
• Analysis included FDA approval timing relative to World Health Organization (WHO) Prequalification, Essential Medicines List (EML) inclusion, and initial use in endemic countries.

Main Results:

• 57% of awarded products achieved WHO Prequalification, and 57% were listed on the EML.
• FDA approval occurred a median of 8.7 years after initial regulatory approval or use in endemic countries.
• FDA approval was a median of 5.2 years after WHO EML inclusion.

Conclusions:

• The PRV program appears to have primarily incentivized regulatory filings for established therapies rather than fostering innovation or enhancing access to new treatments.
• Recommendations include reforming the program to link voucher eligibility to equitable pricing and registration in endemic countries.