Final GDUFA I Activities Report Issues – How Does the 5-Years Look

Well after the first 5 years of GDUFA I, we now have a comparative look at all 5 years for various metrics reported by the FDA in their Activities Report of the Generic Drug Program.  In the chart below the 5- year highs are bolded and some trends can be seen. For instance, the number of post CRL meetings was highest in year two of the GDUFA program.  Perhaps as firms better understood the comments received the need for post CRL meeting was tempered.

Other notable items include:

  • RTRs increased as guidance became available and OGD began enforcing its contents more strictly. Albeit the number almost halved in year 5 of the program.  Does this mean sponsors are learning?
  • Withdrawals are higher in the last two years of the program possibly because of all the M&A activity, or, because firms were paring down their applications to gain a lower tier in the GDUFA II program fee structure (end of year 5). Probably a combination of both.
  • Approvals continue to climb with new highs hit in the last three years of GDUFA I
  • CRL appear to have declined over the last two years and this is thought to be due to the increase in approvals. As I have mentioned in previous posts, when CRLS go down approvals seem to go up!
  • ANDA receipts surprised everyone. We know what the big bump was in FY 2014 with the new stability requirements and firms beating the clock by making submissions before the new requirements took effect. But the 2017 numbers are high because firms tried in part to beat the new GDUFA II ANDA fees. Over all the pace of ANDA submission is well above FDA estimates.
  • DMF completeness review decrease over time to be expected, as fewer new DMF are introduced into the system.
  • Controls are skyrocketing – I assign two reasons to this, 1) firms don’t want to get it wrong and 2) they are seeing things in the OGD reviews that they have never seen in previous reviews. As one sponsor noted we asked a lot of “nice to know questions but not need to know for approval”.
Fiscal Year 2013 2014 2015 2016 2017
Refuse to Receive 150 173 236 246 142
Withdrawals 107 179 170 248 214
Approvals 440 409 492 651 763
Tentative- Approvals 95 91 120 184 174
Complete Response 1251 1254 1880 1725 1603
DMF Completeness Rev 1699 1706 880 886 820
ANDAs Received 968 1473 539 852 1306
CBE Supplements NA NA 5361 5666 6324
PAS Supplements NA NA 480 478 415
Controls 953 1087 1472 1883 2667
Post CRL Meeting Request 23 717 56 36 30

NA- not reported in the same format as later years so omitted from this chart

So there you have it.  GDUFA I in a single table and although these metrics don’t come close to telling the entire story they certain are fun to look at and speculate about!