Dr. Kathleen “Cook” Uhl, Director of the Office of Generic Drugs provided an update on the progress of OGD in the implementation of GDUFA I.  Despite the “tension” and uncertainty noted by the panel that preceded her (see yesterday’s post), Cook delivered a strong message that OGD has meet all of its GDUFA goals to date and has gone above and beyond the goals outlined in the GDUFA goals letter.

Since the implementation of GDUFA, FDA has exceeded its hiring goals and through 2015 has hired 1192 (GDUFA goal 923) staff.  She noted the scope of the task of training this large number of diverse individuals and getting them productive.

Cook noted that this transformation of the review and IT program was necessary to meet the rigorous goals that the Agency must meet.  Now that the hiring is over and the IT platform operational, the work really begins.  However, to further complicate the workload issue is that OGD has received significantly more ANDA submissions over the first three year of GDUFA than were anticipated. (GDUFA estimate was 750/year with the number of actual ANDA receipts were 1103, 968, 1473, 545 from fiscal year 2012-2015.  With current submissions for 2016 looking more like another 900-1000 year.) OGD will have a lot of additional work to do.

The Director also noted that the numbers of approvals are moving in the right direction (see FDA chart below) with OGD hitting an all-time high of 99 approvals and tentative approvals in December.  In addition, OGD is likely to meet it year 5 goal for first review of the “backlog” applications in just a few months about a year ahead of the actual goal date (goal is 90% by end of year 5 and they are at 84% now).  The filing backlog has also been eliminated with real-time filing reviews occurring on an average of 31 days.



To further support the increased communication with industry, Cook provided a graph showing the number of interim correspondences with industry between receipt of the application and issuance of a Complete response letter (CRL).  Quite an accomplishment, for sure, now only if the industry could respond within the designated time line.



In addition to the IRs and ECDs, OGD/OPQ are issuing about 100 CRLs each month.  The goal for controlled correspondence response is 70% within 60 days is being significantly exceeded and runs in the mid to high 90% range.

OGD has been very active in issuing product-specific ANDA guidance.  In FY 2015 alone, OGD issued 154 new product-specific BE guidance documents and revised 69. And in a big surprise, OGD noted that it approved 8 first cycle approvals for the October 2014 cohort (51 applications that just reached their GDUFA goal date in January, 15 months after submission), which represents 12% of the number of ANDAs received in that cohort month and year.  Given that OGD’s rate of first cycle approvals has historically been below 1% – that represents a major accomplishment.

The OGD overall backlog still looks a bit like Mount Everest, but OGD is donning the equipment to get to the summit.  Let’s keep our eyes on the prize and see how they do.