FDA and industry have moved from setting parameters to discussing specifics of a monograph user fee program, though whether an agreement will result is not yet known
User fees require congressional authorization
Potential legislative vehicles for establishing the program include PDUFA or animal drug fees reauthorization
Unlike Rx program user fees to help support FDA's review of a backlog of NDAs, OTC user fees would support a program to which drug firms would submitting proposals
Potential OTC market improvements that monograph user fees could support include expediting label changes, shorter procedures to amend monographs, or a more dynamic process that allows for new indications, ingredients, and dosage forms.

OTC Monograph User Fees: FDA-Industry Talks Move From Basics To Details

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