PDUFA VII to feature $4M fee, focus on cell, gene therapies

FDA and biopharma industry representatives have agreed on most elements of the next Prescription Drug User Fee Act deal, including an increase in the application fee to about $4 million by 2027 from the current $2.9 million level, sources briefed on the negotiations told BioCentury.

Over the decades, PDUFA has grown from a supplementary source of income into an essential financial pillar for FDA’s oversight of drugs, a mechanism for increasing the predictability and transparency of regulatory procedures, and a vehicle for setting and funding priorities. Total drug user fees provided to the agency have grown 1,675% from the program’s inception in 1994 to 2021.  The new agreement will continue the trajectory of increases in fees; by 2027, the cost of getting a new drug reviewed will have increased 2,369% from the program’s inception. ...