High Risk Drug Domestic and Foreign Drug Inspections – Get Ready!

After slogging through some of the FDA dashboards, I came across one that I felt was worthy of mention.  The FDA’s Office of Regulatory Affairs (ORA) has apparently begun the process of scoring drug manufacturing establishments in their risk-based inspection program.  The FDA has been talking about risk-based inspection (as well as risk-based review) ever since I was at the Agency, back when dinosaurs roamed the earth!  The Agency states on the ORA dashboard (here) “FDA is continuing to develop a more quantitative risk model to help predict where FDA’s inspections are most likely to achieve the greatest public health impact. The Risk-Based Site Selection Model provides a risk score for each facility, which is a function of four component risk factors – Product, Process, Facility, and Knowledge.”  While there is no further explanation, nor a narrative of how the scoring is applied, there are metrics for the first quarter of FY 2017 and targets for high risk inspections listed for each of the four quarters.

Quite interestingly, the first quarter’s (October – December 2017) target was 150 such inspections, but the actual number of high risk inspections was only 72. There is no reason why less than 50% of the target was achieved for the quarter.  Perhaps there was a slower than expected initial program roll out; perhaps the FDA has not assigned scores to a sufficient number of firms.  Who knows, but the ORA targets for high risk inspections for the following three quarters are listed as follows:

Time Period                      Target          Number

Oct – Dec 2016                   150                 72

Jan – Mar 2017                   225                TBD

Apr – Jun 2017                    225               TBD

Jul – Sep 2017                      150                TBD

I think the take-home message from the targets projected is, look out high risk firms because FDA is planning 600 inspections of your facilities in the next 9 months.  I guess the problem in sounding the alarm is that I don’t know if high risk firms know who they are?  Therefore, everyone should be ready!