Despite the shutdown, it appears that the OGD is still pumping out ANDAs and updating required statistical metrics as it chugs along under what must be stressful conditions.
November 2018 (Month 2 of FY 2019) showed just four ANDAs received refuse-to-receive actions (four for standard ANDAs and one for a priority ANDA. The OGD acknowledged ninety ANDAs and of the ninety‑nine approved ANDAs in November, the OGD says that eleven were first-cycle approvals (FCAs) and of the twenty‑nine tentatively approved applications, six were FCAs. That represents a slip in percentage for FCAs to around 11% for November compared to 22% for October. Too early for any real trending conclusions but clearly this demonstrates quite a month-to-month swing in the percentage of ANDAs that are approved during the first-cycle review.
It also appears that firms may have finally thinned out their cache of ANDAs that they are no longer marketing as November saw the fewest number (six) of approved and pending application withdrawals since the program fee was placed into effect at the start of GDUFA II.
Complete response letters rebounded to 230 and discipline review letters surged to 254, while information requests stayed fairly constant at 364 compared to the previous month. ANDA amendments hit the lowest number (187) since March of 2018.
All the other metrics that the OGD report appear to be in line with previous figures; that is, at least nothing else jumped out upon first blush.
It appears that the government shutdown has not significantly impacted the OGD yet; however, most employees have not yet missed a paycheck, which will likely occur on January 11th if the budget appropriations are not passed. What impact that may have on morale and productivity will have to be judged after that. Let’s hope those in Washington use better sense to resolve this issue than invoking the “it’s my toy and if I don’t get to play with it no one does” mentality we have seen for the past few weeks!
