Comments on the Commissioner’s National Priority Voucher (CNPV) Pilot Program

These comments, submitted as a follow-up to testimony at FDA’s June 4, 2026 public hearing, recommend that FDA pause the Commissioner’s National Priority Voucher pilot until Congress authorizes it, given that regulatory review accounts for less than a tenth of drug development timelines and that the program risks politicizing approval decisions while imposing an unfunded workload on FDA reviewers. Should the program proceed, vouchers should be limited to generic drugs, and the agency should address reviewers’ reported concerns about the program, require advisory committee review of drugs seeking voucher-based approval, and provide more robust opportunities for patient and public input during the voucher selection process.