ARTICLE | Politics, Policy & Law

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

Funding increases for CBER as FDA expects onslaught of applications for new modality therapies

March 12, 2021 9:32 PM UTC

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. ...