The next cycle of FDA prescription drug user fee negotiations is moving through the White House review process, according to sources. The deal sets user fee levels for the agency from 2028 through 2032, a window that matters for staffing, review timelines, and the agency’s ability to manage modern trial designs. This comes as leadership and restructuring discussions continue amid scrutiny of how quickly and predictably FDA can handle high-volume and biologic-heavy oncology submissions. For biotech firms, user fee levels often translate into practical expectations around review resourcing and operational continuity. Market participants will likely focus on how the final user fee package is framed, including whether it pairs fees with programmatic commitments for earlier-phase review and review-workforce stability. The White House review adds a political step that can delay certainty for planning purposes across sponsors.