Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.
A proposal to raise $22m to $34m in annual user fees from OTC manufacturers – primarily from facility registrations – is contained in a discussion document being circulated by Sens. Johnny Isakson, R-GA, and Bob Casey, D-PA.
Fees would also be raised when companies request changes via the monograph system, which would be recast into a two-tier program. (Also see "Two-Tier OTC Monograph Approach Could Come...
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
