Update of 2016 Activities Report of Generic Drug Program

Based on the updated numbers for 9 months of 2016 for metrics other than Approvals, Tentative Approvals, receipts of original ANDAs, which were reported on in a previous blog post (here), Office of Generic Drug (OGD) numbers point mostly towards higher numbers.

Some metrics have only been reported in the same context for the last two years (first years of GDUFA goals).  That is because the format of the reporting from this Generic Report was changed in FY 2015 and it is, therefore, difficult to determine the relationship of some of the reporting number for the first two years of the program.  For instance, for Changes Being Effected (CBE) supplements were separately reported only beginning in FY 2015.  That year saw submission of 5361 CBEs and, so far, through June 2016, OGD had received 4112 CBE supplements (projection for the full year at current rate would be 5483 or just slightly higher than last year).  The situation is the same for Prior Approval Supplements (PAS), which came in at 480 in FY 2015 and, thus far in FY 2016, stands at 341 through June with a projection of 455 for the full FY (or a slight decrease).

Categories of metrics that have been consistently reported over the 4-year period of GDUFA are Drug Master File (DMF) completeness reviews, Complete Response Letters (CRLs) and Refuse-to-Receive (RTR) actions on original applications.  The numbers for those metrics for the four GDUFA years along with actual numbers through June and projections for the full FY 2016 are provided in the chart below.

  FY 2016 FY 2015 FY 2014 FY 2013
DMF 717 (956) 880 1706 1699
CRL 1196 (1595) 1180 1254 1251
RTR 206 (275) 236 173 150


The trend in the numbers make perfect sense.  For instance, one would expect the number of completeness acceptability reviews for DMFs to decrease, since this review is only done a single time and the number of DMFs submitted are relatively low, since multiple firms may reference the same DMF.  CRLs look to have risen, and that is to be expected since the organization of OGD and Office of Product Quality (OPQ) are staffed up and fully trained, and that number should increase, as these groups becomes more efficient with output growing.  The number of RTR letters have risen each FY of the GDUFA program, as the requirements over time have become more stringent.  As OGD further outlies its RTR criteria and as industry becomes more familiar with it, hopefully, we will see a decline in that number over the years to come.

We anxiously await the approval and receipt figure for July, which should be published in a few days, and we will report on those as soon as they are posted.