A key FDA expedited-review instrument is coming under pressure as stakeholders call for clearer guardrails—or a pause—around the Commissioner’s National Priority Review Voucher program. Experts cited uncertainty over how vouchers are selected and whether senior leadership can steer candidate decisions. The pilot, launched last year to streamline review for products tied to U.S. national priorities, has already supported several approvals via expedited pathways, and the FDA has distributed 22 vouchers to therapies spanning oncology, rare disease, mental health and other priority areas. Consulting and patient-advocacy voices in the piece argue the program is redundant relative to existing FDA processes and warn that shifting internal leadership dynamics may be driving outcomes before full program details are established.