FDA user-fee negotiations for the next cycle moved into White House review, according to sources describing scrutiny of a deal that sets prescription drug user fees for 2028 through 2032. The process underscores how tightly the schedule and the final numbers are tied to broader federal decision-making. The user-fee framework typically influences resourcing and review timelines across the agency, which is especially relevant as oncology and gene therapies compete for efficient regulatory throughput. Industry analysts have also linked user-fee cycles to incentives for early engagement and review capacity. With the White House examining the agreement, the next steps are expected to shape timelines for the pharmaceutical industry’s planning around submissions and planned label expansions. Separately, Rick Pazdur told ASCO attendees that recent turmoil has opened space for FDA restructuring, emphasizing that the agency could rebuild staffing and administrative structure rather than restore the status quo.