Trump Budget Proposes Steep Hike in FDA User Fees
President Trump released his first budget blueprint last week, calling for FDA user fees to rise to more than $2 billion for fiscal 2018 — up from the $1.36 billion set for 2017 — and for $1 billion to fund the 21st Century Cures Act.
The current user fee reauthorization package being considered by Congress for devices would aim to collect $183 million in fiscal 2018, increasing to $213 million through fiscal 2022.
The fees were previously negotiated by the FDA and regulated industry, to cover medical product reviews through fiscal 2022. Both House and Senate committees have user fee hearings scheduled.