ANDA Approvals Are Ticking Up but CRLs Do Not Appear to be Rising


Partial updates to the Generic Activity Report for FY 2015 were recently published and, while we see a recent surge of approvals, the number of Complete Response Letters (CRLs) issued appears to be flat across all of the first three GDUFA Cohort years.

Actions this FY FY 2013 FY 2014 FY2015
Refuse to Receive 150 173 186*
Withdrawals 107 179 140*
Approvals 440 409 492
Tentative Approvals 95 91 106*
Complete Response 1251 1254 1079*
CMF Complete Assessment 1699 1706 775*

*- thru August 2015

What does this chart tell us about FY 2015 and the progress the Office of Generic Drugs (OGD) has made?

  • OGD approved more ANDAs in FY 2015 than since at least 2009 with the exception of 2012 when they approved 517 ANDAs.
  • It appears that OGD is refusing-to-receive (RTR) a larger number of ANDAs as GDUFA rolls along (remember that September numbers are not in for the FY 2015 and still OGD has RTR-d 13 more than FY 2014). The numbers for RTRs have trended up each successive year of GDUFA so far.  Interesting also is the fact that the number of receipts are way off for FY 2015, where 509 ANDAs were received vs. FY 2014 when 1473 ANDA were received.  Thus, the % of RTR actions was much higher in FY 2015.
  • It seems CRLs have not increased proportionally to the large increase in staff and the final training of those staff, as the numbers of CRLs are fairly consistent across all three GDUFA years (again, remembering that the September 2015 figures for CRLs have not yet been reported). But just, to stay even with previous year productivity in this arena, OGD would have had to issue about 200 CRLs in September.
  • DMF reviews dropped considerably, but that is understandable since, once the DMF undergoes its initial review, then the specific DMF does not have to be reviewed with each successive DMF reference for other ANDAs. One would assume that OGD is using those excess resources that would have been reviewing DMFs to work on either CMC supplements or ANDAs.

Parsing the numbers, it is easy to make casual observations about trends, but I don’t really think that we have enough data points yet to make any reasonable overall generalizations.  I am a bit surprised at the CRL total for the year; maybe they would be higher if OGD was not trying to drive ANDAs to approval instead of just issuing a CRL.  However, we must remember that hiring and training under GDUFA was really over a three-year span.  Thus, some 600 direct review positions and another 300 + generic drug review support positions outside of OGD and Office of Product Quality (OPQ) has not yet translated into significantly increased visible output.  We will definitely give OGD and OPQ credit for taking steps to improve communication, review efficiency, and processes transparency and address issues outside of the GDUFA Goals Letter, but, as we all know, numbers speak louder than words.  We will keep an eye on these numbers and we do believe they will continue to improve.