Late yesterday, the OGD finalized its 2018 statistical chart in its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance which can be found here. There are some interesting figures and comparisons to previous years that are discussed below.
Let’s look at refuse-to-receive (RTR) actions to start. FY 2018 saw the fewest RTRs since the start of GDUFA.
|FY||# RTRs Reported|
It appears that, as the program ramped up, requirements were tightened and the Agency provided more guidance on RTR standards and the number of RTRs went up to a high of 246, which represents about 29% of the 852 ANDAs submitted in FY 2016. With a rapid decrease after FY 2016, it appears that the industry learned quickly and continues to do better.
We have already reported that FY 2018 showed a record number of approvals (here) as well as a record number of complete response letters (2,648, with the next highest GUDFA level seen in FY 2015 at 1,725).
The OGD is up-to-date on issuing acknowledgement letters as it received 1,044 ANDAs in FY 2018 and acknowledged 1,054 (some ANDAs apparently left over from FY 2017, but pretty close) and, remember, there is about a one-month offset for ANDA receipt and issuance of an acknowledgement letter for most ANDAs now that the OGD is caught up in this area.
There were 2,357 amendments submitted to ANDAs in FY 2018, with the split between major and minor being 1,078 and 1,250, respectively, with only 29 unsolicited amendments reported for the entire FY. The low number of unsolicited amendments shows that the industry has received the message – unsolicited amendments will usually have a detrimental impact on a review clock. Good comparisons for previous FYs are not possible because of a change in the reporting requirements.
One other statistic that stood out is a GDUFA record-high number of control correspondences submitted asking questions of the OGD/OPQ. The number hit 2,933 in FY 2018. This either means that the industry has more questions or that evolving approval requirements and issued draft or final guidance is not as clear as it could be. Let’s see how FY 2019 stacks up with FY 2018 as we move through the second full FY of GDUFA II.