We Need to Move the Freight and Not be Late, Says OGD’s Uhl in GDUFA Update; But for Many in Industry, “Seeing is Believing”

By Kurt R. Karst –

For those in the generic drug industry who attended the Generic Pharmaceutical Association’s (“GPhA’s”) annual meeting in Miami, Florida earlier this week, the message from Office of Generic Drugs (“OGD”) Director Dr. Kathleen “Cook” Uhl in her Generic Drug User Fee Amendments (“GDUFA”) progress report was clear: We have a lot of work to do, but progress is being made.  Of course – and to borrow the tagline from one of the industry’s giants (Mylan) – “seeing is believing.”

We’re now well into the second quarter of Fiscal Year 2015, which corresponds to GDUFA year 3 cohort applications.  For that cohort, FDA agreed to review and act on 60% percent of original ANDAs within 15 months from the date of submission.  (Those goals are ratcheted up in Fiscal Year 2016 [year 4 cohort] and Fiscal Year 2017 [year 5 cohort] where FDA agreed to review and act on 75% of original ANDAs within 15 months, and 90% of original ANDAs within 10 months, respectively.)  GDUFA includes other performance goals for Fiscal Year 2015, including with respect to Prior Approval Supplements (“PASs”) and Controlled Correspondence.

Although we’re still far away from the first 15-month GDUFA goal dates for original ANDA submissions (i.e., January 2016), it’s clear that OGD has been working hard to put in place a system to ensure that goals will be met.  (And by meeting goals, we mean approvals, not complete response actions.)  For example, OGD has surpassed GDUFA hiring goals (as shown in the table below from Dr. Uhl’s presentation), enhanced the Office’s information technology systems to realize various efficiancies, made significant changes to the Office’s structure, aligned other FDA components necessary to a successful (and prompt) ANDA review system, and published numerous guidance documents and manuals of policies and procedures (see, for example, our previous posts here, here, and here). 

OGD’s efforts have thus far have resulted in some pretty impressive progress for cohort year 3 submissions and for other goal-related Fiscal Year 2015 submissions.  Consider, for example, the information in the slides below from Dr. Uhl’s presentation.

Two items in particular in these slides stand out to us: (1) the average time for FDA’s initial review and acceptance of an ANDA is now less than 30 days (specifically, 27 days); and (2) a large number of ANDAs are still the subject of Refuse-to-Receive (“RTR”) actions.  That last bit is something that folks should be able to correct with little effort.  Most of the RTR letters from FDA cite inadequate or improper payment of GDUFA user fees, inadequate stability data, dissolution data or bioequivalence data (even failed studies), and incomplete or untimely responses to minor deficiency communications. 

While OGD certainly seems to be progressing well with GDUFA year 3 cohort submissions, the Office’s ability to “move the freight” on pre-GDUFA submissions, as well as year 1 cohort (Fiscal Year 2013) and year 2 cohort (Fiscal Year 2014) submissions (the so-called “GDUFA donut hole”), is still a work in progress and an ongoing issue of concern for the generic drug industry. 

To give readers a sense of the amount of pre-GDUFA and donut hole freight OGD has to move, below is a series of slides from Dr. Uhl’s presentation showing some pretty large numbers:

The following two slides from Dr. Uhl’s presentation show that OGD is making some progress, but there’s clearly still a lot of work to be done.

So, how will OGD hold itself accountable and assuage generic drug industry concerns (and concerns that are likely growing with FDA’s recent announcement – here at page 65 – that the median ANDA approval time was a whopping 42 months in Fiscal Year 2014, and is predicted to remain at that level for the next two fiscal years)?  The answer seems to be: assign Target Action Dates (“TADs”) to all pre-year 3 cohort applications. 

TADs are a relatively recent OGD creation that the Office has reportedly been assigning to some ANDAs for several months now as a sort of dry run for meeting GDUFA performance goals.  A TAD is not a GDUFA action date, but rather an internal OGD deadline for action on an application.  At the GPhA annual meeting, Dr. Uhl announced that OGD will extend the TAD initiative to all pre-year 3 cohort applications – and notify  ANDA applicants of the assigned TAD.  OGD will roll out the enhanced TAD initiative over the next several months, as discussed in the slides below.