Today, in the Federal Register (here), the FDA announced the FY 2019 Generic Drug User Fees which include application fees, DMF fees and establishment fees for various types of facilities and program fees.  While fees for most of the items showed only modest increases, the ANDA and DMF fees increased the most, at 4% and 15% respectively.  The Program Fees, however, showed the largest increase at whopping 17%.

GDUFA II – FY 2018 Fees             GDUFA II – FY 2019 Fees              % Change

Original ANDA    $171,823            Original ANDAs $178,799                    +4%

PAS                          None                PAS                         None                        NA

DMF                     $ 47,829              DMF                      $55,013                   +15%

Domestic API      $45,367               Domestic API     $44,226                      -3%

Foreign API         $60,367               Foreign API        $59,226                       -3%

Domestic FDF     $211,087             Domestic FDF    $211,305                     +1%

Foreign FDF        $226,087              Foreign FDF       $226,305                    +1%

Domestic CMO   $  70,362             Domestic CMO  $70,435                     +1%

Foreign CMO      $   85,362            Foreign CMO     $85,435                      +1%


GDUFA II Program Fees

                                            FY 2018          FY 2019             %change

Fee for large* mfgrs            $1,590,792    $1,862,167             +17%

Fee for medium** mfgrs    $636,317       $744,867                +17%

Fee for small *** mfgrs      $159,079       $186,217                +17%


The GDFUA II legislation sets the base user fees at $496,600,000 to be adjusted each year for inflation using (what to me seems like) a complicated set of calculations that yields FY 2019 total fees at $501,721,000.  We just tipped the half billion-dollar mark, folks!  ANDA fees make up 33%, FDF and CMO facility fees are to make up 20%, API facility fees make up 7%, Program Fees make up 35%, and the remainder comes in the form of one-time fees from DMFs. The FDA calculates that in FY 2019, the Agency will receive 456 fee-eligible DMFs.

The Agency also projects that it will receive 926 fee-eligible ANDAs in FY 2019, even though it is likely that over 1000 ANDAs will be received this FY.  There are lots of other great factoids, like the numbers of both domestic and foreign finished dosage form facilities, API facilities, and CMOs that the FDA anticipates will generate fees.  The real questions are, how will the new fees impact generic drug costs and the ability of generic drug manufacturers to operate profitably given the squeeze in the distribution channel?