ANDA Supplements Spike in April

The Office of Generic Drugs (ODG) saw the largest number of changes being effected (CBE) supplements (618) as well the largest number of prior approval supplements (PAS) (57) so far, this fiscal year. While these numbers did not break any previous records (678 CBEs in September 2016 and 71 PAS in August 2016) they certainly show a spike from past months in FY 2017. (see recently updated Activities Report of the Generic Drug Program(FY 2017) here.

While there are no GDUFA goal dates assigned for review of CBE supplements the PAS supplement do have specific GDUFA goal dates.  Increases in OGD workload in the face of increased ANDA submissions and or potential FDA layoffs if a budget agreement or continuing resolution is not extended by next week, could spell trouble for meeting GDUFA goal dates for original or supplemental applications.  We previously reported on the increase in ANDA submissions (here) and looking at the number for the first 6 months of FY 2017 we are looking at a potential of 1472 ANDAs being submitted this FY if the current rate continues.

Remember that OGD was staffed under GDUFA I for 750 ANDAs/year and for GDUFA II proposed legislation at about 800/year.  With the numbers we are seeing(over 1000/year), it may be hard for OGD to meet its mandated GDUFA goals.  Perhaps the remainder of the year will see a slow down before the kick off of GDUFA II, but we had hoped for that before and it is not come to fruition.