OGD Updates its October 2016 Report on the Activity of the Generic Drug Program (FY 2017)

On Monday, the Office of Generic Drugs (OGD) updated its report on the activity of the Generic Drug Program to include additional data. As this is the report for the first month of the new fiscal year (2017), any comparative data needs to come from previous fiscal years. The October report adds Refuse-to-Receive (RTR) actions, withdrawals, controls, information on supplements received, DMF completeness assessments, and a number of post CRL meeting requests.

There were 9 RTR actions reported for the month, which represents a tie for the lowest number of RTRs for any month in FY 2016 (September also had only 9 RTRs).  There were 9 ANDAs withdrawn and (as explained in previous posts) we don’t know the make-up of the withdrawn ANDAs.  That is, we don’t know if they represent old ANDAs that were pending, new ANDA that were pending, or ANDAs that have been previously approved.  We assume it may be a combination of both but are not certain as no additional information is currently publicly available.

Controls were submitted at a brisk 153 for the month. The number of Changes Being Effected (CBE) supplements received was 493, only slightly above the 472 average/month for FY 2016. Prior Approval Supplements (PAS) were at 43, again slightly above the FY 2016 monthly average of 40.  And there were only 2 post-CRL meeting requests.

OGD also completed 52 DMF completeness assessments.

The activity will be interesting to watch over the next few months to see how FY 2017 is going to compare to previous years.  With GDUFA II less than 11 (almost 10) months away, there will be a lot of eyes honed in on the monthly activity reports.