The debate over accelerated review continues as stakeholders urged FDA to pause its Commissioner’s National Priority Voucher program during a June 4 listening session. Companies and patient groups described both early successes and concerns about process design, particularly how accelerated timelines are introduced and whether public input is adequately addressed. At the same time, pharma compliance teams are preparing for shifting CMS Average Sales Price (ASP) requirements, including new certification elements and expanded handling of maximum fair price units in quarterly calculations. Executives warned that the compressed timeline demands decision-making structures and governance frameworks well in advance of product launch cycles. The combined theme is that speed is being layered on top of stricter pricing and reporting compliance, increasing operational complexity for sponsors and requiring tighter coordination across regulatory, pricing and data infrastructure teams.