New agency data show historic departures from the FDA’s drug and biologics centers, with nearly 1,000 net exits in the last quarter of fiscal 2025. The staffing shortfall raises operational and review‑capacity concerns for sponsors planning filings and could affect review timelines for high‑priority applications. Separately, the Congressional Budget Office reported unexpected costs tied to the Orphan Cures Act, finding the law created windfalls for several large pharma companies and prompting the CBO to raise its long‑term cost estimates. The analysis named specific firms and highlighted budgetary consequences of expanded orphan protections. Combined, the workforce strain at FDA and shifting budget impacts of orphan drug incentives create a tougher regulatory and policy backdrop for biotech. Companies should plan for extended agency interactions, higher policy scrutiny and potential shifts in reimbursement and incentive structures.