President Trump’s first budget blueprint calls 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 would aim to collect $493.6 million annually for generic drug reviews, and $45 million for biosimilars in fiscal 2018.
The proposed PDUFA fee structure for prescription drugs has not yet been made public, but both House and Senate committees held user fee hearings this week.
Trump’s proposed increase would remove the need for new federal budget appropriations to cover pre-market reviews. The increase in revenue from user fees could equal approximately one-third of the FDA’s total annual budget appropriation from Congress.