Generic Drug Activity Report for FY 2015 Updated and Revised


The day after we reported on ANDA receipts, Approvals, and Tentative Approvals, the Office of Generic Drugs (OGD) updated and revised its Activities Report of the Generic Drug Program for FY 2015.  The update was through June but, again, not all data fields were updated.  The report states in a footnote that the information on amendments for April, May, and June will be forthcoming.  The report can be found here. Some interesting observations about the revised report include the way OGD reports certain data elements.  For instance:

DMF raw receipts have been eliminated since DMF Completeness Assessments present a more accurate indication of workload

Starting FY15 ANDA Original Receipts are reported as raw receipts (versus filed receipts).

RTRs revised to include both RTR due to failure to pay user fees and RTR due to technical reasons.

FY 15 Controls have been revised to count only those requests appropriate for a control.

There were 20 ANDAs for which OGD issued refuse-to-receive actions in June, which is about the monthly average for FY 2015.  OGD also performed 65 DMF completeness assessments in June, which is about 10% lower than the monthly average of 77.  OGD saw a total of 21 ANDAs withdrawn for various unnamed reasons in June, bringing the total of withdrawals to 106 in the first 9 months of FY 2015.  It is not clear if these withdrawals represent just approved ANDAs (which was the way this figure was reported when I was at OGD) or both approved and pending applications.  The impact on the backlog may or may not be affected by the withdrawals as this would depend on the status of applications OGD is actually counting in that figure. I assume they are withdrawals of approved ANDAs

FDA issued 116 complete response letters (CRLs), which is 1 more than the previous high of 115 that was issued so far in any month in FY 2015 (monthly average for FY 2015 was just over 93).  Industry anticipates a steady increase in the number of approvals and CRLs every month, given the fact that staff has been hired and trained and, thus, these productivity measures should be continuously improving.

OGD received 37 prior approval supplements (PAS) and 472 changes being effected supplements (CBE) in June along with 141 controlled correspondence submissions.

The workload continues to arrive at the OGD doorstep.  Getting it out in an efficient and transparent manner is very high on industry’s agenda and is also a goal for the Agency.  We will keep you updated on OGD’s progress as we move closer to Cohort year 4 and GDUFA II.