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OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

 
• By Malcolm Spicer

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.

Capitol House

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...

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