With a record number of ANDAs received by the Office of Generic Drugs (OGD) and a modern day record low number of approvals, we move into FY 2015 still looking for the bright spot. OGD received 1473 ANDAs for FY 2014, which included a record 635 monthly receipt record and two monthly low receipt records of 4. September saw 25 ANDA submitted. As far as approvals go, the total just surpassed the 400 mark at 406 for the full fiscal year. OGD also issued 91 tentative Approvals in FY 2014
In review of Complete Response Letters (CRL), September saw a monthly low of 75 for the year, which is only 2 more than the FY 2013 monthly low of 73 seen in March of 2013. CRL totals for FY 2014 were only slightly higher than FY 2013, with 1254 vs 1251 respectively….and this is with a significantly staffing increase over last FY. This is likely still reflective of the high time cost of training the new staff and the inefficiency that the training load creates. Productivity is likely going to increase as the training cycle comes to a close, but how long can industry wait for this to happen?
Refuse-to-Receive (RTR) issuances in FY 2014 were significantly higher, at 173 vs 107 for FY 2013. This likely signifies the increase stringency in RTR criteria announced at the end of FY 2013.
Post-CRL GDUFA meeting requests totaled 85 in FY 2014 with 60 meeting being held, only 8 denied and 3 cancelled and 11 pending, and a number of 3 granted rounds out the 85 total requests. Meeting requests appears to be averaging around 5-6 per month.
While I am not certain I see much good news in the number for year two of GDUFA, year three’s metrics will likely kick in the new reality-let’s hope the rationale for not collecting metrics on applications for year 1 and 2 (due to the ramp up in hiring and the drain on resources that training requires) translates into an OGD corps ready to meet the challenge of GDUFA’s metric years.
One other interesting factoid is that we expected another rush after October 1, 2014 in application submissions for firms that may have delayed submission until then to take advantage of the first year of metrics. So far, according to OGD, they have not seen any abnormal rush. We will keep track of this issue. One reason that this rush has not yet been seen could be related to the big June 2014 push and other applications still waiting for the generation of the (now required) 6 months of accelerated and room temperature stability for filing.
All in all, the first two years of GDUFA have the industry very concerned. Year three may be a breakout year, but OGD still has the remaining hires to be brought on board and assimilated into the program. OGD is listening to industry concerns and is trying to address them, even though some of the issues are outside of the GDUFA goals letter. Their success is dictated by the goals but industry will be watching closely for even more signs of progress.