ARTICLE SUMMARY:
User fees would bankroll more than half of the FDA’s FY2027 budget request. Excerpted from Pathways’ Picks April 7: Shuren Venture Fund, MDUFA Agreement, Global Digital Health Updates.
FDA’s total device program budget would rise above $1 billion for the first time ever under the Trump administration’s FY 2027 budget request. However, more than half of the money would come from industry user fees and the additional funding in the request would cover only seven new full-time equivalent employees, increasing staff levels from 2,323 to 2,330 FTEs. In the April 3 request—which can be amended and must be approved by Congress—FDA asks for $466 million in appropriations from Congress for devices next year, an $11.1 million (2.4%) increase compared to current funding. This would add to $539 million in industry user fees, an $80.4 million (17.5%) rise. The administration indicated it needed to request at least a $9.1 million increase to meet the minimum appropriations threshold required to trigger continued collection of user fees. It added $2 million more as part of FDA’s planned investment in expanding global inspection capacity.