The public meetings from MDUFA V negotiations held earlier in the year touch on the question of how much user fee funding FDA will receive without providing a figure. Industry has now reportedly put the figure at $1.2 billion, opening a new front in the negotiations with FDA.
While the figure is up on the almost $1 billion agreed for MDUFA IV, a sizable slice of the extra cash is accounted for by carryover balance. Removing the carryover from MDUFA IV shrinks the industry offer to $1.1 billion. The use of the carryover balance was a focal point of MDUFA meetings earlier in the year, with FDA seeking industry feedback on how to allocate the funds.
