The US Food and Drug Administration (FDA) has announced that user fees charged for Abbreviated New Drug Applications (ANDAs) in fiscal 2014 will rise 24%, from $51,520 to $63,860.
Fees for Prior Approval Supplements (PAS) for ANDAs will also go up 24%, to $31,930, and fees for Drug Master Files (DMF) will increase 48% to $31,460 for the year, October 1, 2013-September 30, 2014.
Annual facility fees for finished dosage forms (FDF) will increase around 25%, to $235,152 for foreign facilities and $220,152 for domestic facilities, but rates for active pharmaceutical ingredient (API) facilities for both foreign and domestic facilities will be reduced, to $49,515 and $220,152, respectively.
FDA says it is expecting some 911 ANDAs to include a filing fee in fiscal 2014, and to receive 583 fee-paying DMFs.
Discussing the different rates for foreign and domestic facilities, the agency points out that, under the Generic Drug User Fee Amendments (GUFA) of 2012, the fee for a facility located outside the US “shall be not less that $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the US,” based on the extra cost incurred for conducting inspections outside the US. For fiscal 2014, the differential for foreign facilities will be $15,000.
It also says it has identified a total of 748 FDF facilities, of which 315 are domestic and 433 are foreign, and the latter will pay $15,000 more than the former in fiscal 2014.
Also, 903 API facilities have been identified, of which 128 are domestic and 775 are foreign. Again, the differential for foreign facilities is $15,000.
FDA says it has “minimised the increase in fees as much as possible,” but adds: “additional resources will enable the agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.”
Indian firms, as the second-largest exporter of drugs to the US, are expected to be particularly hard-hit by the new fees, and some could exit the market, it is suggested. And Indian newspaper The Telegraph quotes Dilip Shah, secretary-general of industry group the Indian Pharmaceutical Alliance (IPA) as warning that, “over a long period of time, if the number of generic players comes down, the lowered levels of competition may increase the prices of generic medicines in the US.”
