FY 2015 First Quarter OGD Stats are Published – Picture is Not Rosy

Well, we now have the actual numbers for various input and output metrics for FY 2015’s 1^st quarter that speaks to the current level of productivity at the Office of Generic Drugs (OGD).  I know that there are training issues that drain resources for new and existing staff.  I know that there are tremendous policy issues that must be addressed.  I know that there have been problems with the new IT platform.   I know that the learning curve relative to coordination of reviews from the various disciplines is steep and, with the number of moving pieces associated with an ANDA review, it is difficult at best to bring an ANDA approval or Complete Response Letter (CRL) in for a landing.  I know all these things, but I also know from the calls I receive that industry is not particularly happy.   I also know that, because of these bumps in the road, enthusiasm for GDUFA is waning, which may make for some interesting and contentious negotiations for GDUFA II.

So, let’s look at some of the numbers.  FDA has hired 923 new GDUFA employees as of October 2014 (that number alone is close to 3 times the OGD staff pre-GDUFA and that number is also about 6 times the number of staff OGD had [155] when I left OGD at the end of 1994).   To be fair, these new employees have been spread out over various components of the Agency, but it also does not include the number of staff already in the programs that contribute to the ANDA review and approval process.

Here are some specific numbers for the first three month of FY 2015 and a comparison to FY 2013 and 2014.

*-   Represents first three month of FY 2015

**- Complete Response Letters

So, what do we see so far this FY?  CRLs have decreased by about 1/3 so far this FY and, for the first quarter same period over the last three years, it is well over a 33% decrease over same quarter for the last two prior FY.  DMF complete assessment numbers have declined, but this is an expected figure since the number of new DMFs submitted or first time reviews have already been completed in year 1 and 2 of GDUFA.

Original ANDA receipts are down substantially over the first quarter FY 2015.  This is good news for OGD. There was not the “big” December numbers that we usually see primarily because the pipeline of ANDA submission was likely depleted by the huge number of submissions in the first half of June 2014, as firms sought to beat the new stability requirements.  On the approval side of the coin, things seem pretty constant over the last three fiscal years.  This is one area where the numbers must be substantially improved if industry is to begin smiling again and if OGD is ever going to get out of the staggering backlog of original ANDAs it has to deal with.

Controlled correspondences seem to be on par with each of the last two years of GDUFA, but the numbers still show that industry has a lot of questions to ask, and now, with the limit on what is classified as a controlled correspondence and who can submit them under the GDUFA metrics, the FY 2015 numbers may actually reflect an increase in actual industry drug development questions.

The numbers are one thing concrete to evaluate performance and, while numbers can sometimes lie, what are we hearing from our colleagues in industry should concern us all.  Here are some snippets.

• We have had a good record with our submissions at OGD with maybe 5-10 deficiencies and minor status of the CRL.  Now we are seeing 20-40 deficiencies and it appears like we all of a sudden don’t know what were are doing.  Senior management is questioning our effectiveness.
• We received two CRLs with minor questions, and then out of the blue, when we were expecting final approval, we received a major amendment CRL.
• We have been working with FDA on a difficult ANDA issue and thought we were circling in on approval based on our last response to a CRL letter, then we got a Biodeficiency letter from FDA that they never got around to sending us (was not in the last CRL) and were told to hold off until we get additional CMC comments.  The FDA said whoops we forgot to send the BE comments.

These are just a few of the issues we have heard from industry over the last few months.  Is this part of the learning curve?  If it is, then industry hopes the curve levels out soon.  One other general issue that we hear all of the time ever since the inception of GDUFA is that we have no idea who to call at OGD if we have a real problem.  The Project Managers (PM) seem to change all of the time and we have to wait for a CRL to see who is assigned because it is so hard to get someone on the phone …or we call and there is a new PM we are instructed to call.  There needs to be a better way to find out who we need to speak with to get either ANDA status or an ANDA issue resolved.

Then there is the problem of when something drops through the cracks.  Who do you call – certainly not Ghost Busters!  But who do you call?  There used to be a team of go-to folks that could solve unique and unexpected problems.  Now the very new and green PMs are just learning the system and don’t know how to ferret out the real problems from the non-problems.  If I had one wish, it would be for a small seasoned go-to force in OGD that can help resolve the hard-to-solve and one-off problems that occasionally arise.

That’s enough for today, but if you have similar problems to share I would love to hear about them.  Contact me at r.pollock@LachmanConsultants.com or if you or your firm needs help with a problem, contact one of our regulatory specialists at 516-222-6222.