The Federal Register today provided the snapshot of generic drug user fees for FY 2022 (here) and the flash may blind you as some new fees have popped up and the program fees have actually decreased, but not by much!
|FEE CATEGORY||FY 2021 Fees||FY 2022 Fees||% Change|
|Abbreviated New Drug Application||$196,868||$225,712||14.6|
|Drug Master File||69,921||74,952||7.2|
|API Manufacturer Domestic||41,671||42,557||2.1|
|API Manufacturer Foreign||56,671||57,557||1.6|
|Finished Dosage Form Domestic||184,022||195,012||6.0|
|Finished Dosage Form Foreign||199,022||210,012||5.5|
|Contract MFG Organization Domestic||61,341||65,004||6.0|
|Contract MFG Organization Foreign||76,341||80,004||4.8|
|Large Manufacturer (> 20 ANDAs)||1,542,993||1,536,856||0.4|
|Medium Manufacturer (6-19 ANDAs)||617,197||614,742||0.4|
|Small Manufacturer (5 or Fewer ANDAs)||154,299||153,686||0.4|
The biggest jump is seen in the new ANDA application fee, which is to be expected as the pot of money has increased due to inflation and the number of ANDAs projected for FY 2022 has decreased to 789 (788) as opposed to the 872 (867) fee-paying ANDAs that were estimated for FY 2021. These figures take into account the fact that the FDA anticipates a few ANDAs will be refused-to-file and resubmitted during the same FY. The actual fee-paying applications that are estimated to be originally submitted are in parentheses.
It is surprising that the program fees have decreased somewhat; however, the formula is quite complex. The FDA explains it this way: “The list of original approved ANDAs from the Generic Drug Review Platform as of April 30, 2021 shows 291 applicants in the small-business tier, 76 applicants in the medium-size tier, and 76 applicants in the large-size tier. Factoring in all the variables for the fourth year of GDUFA II, the Agency estimates there will be 203 applicants in the small-business tier, 69 applicants in the medium-size tier, and 75 applicants in the large-size tier for FY 2022.” Read more about how the FDA reached these numbers in the FR notice above.
Well, now the number crunchers in firms can sharpen their pencils and begin to review their budgets for the FDA’s GDUFA user fees they expect to pay in FY 2022.