Now that FDA has updated its inspection database with inspection types, we have much greater visibility into FDA's inspection behavior. Today, in honor of Ready Room's recent release of pharmacovigilance storyboards, we look at post-marketing PV inspections. Query: How soon is a sponsor's PV function to be inspected after its first commercial product is approved?
First, we looked at the 25 PV inspections that occurred in FY2023, classifying each inspectee by their number of marketed products. The usual disclaimers apply here, as the information is only as accurate as what is published on company web sites.
More than 40% of FY2023 PV inspectees were sponsors with only one or two marketed products, suggesting that the agency does indeed focus the majority of its inspectional attention on new PV commercial departments.
How soon will FDA come calling? We further classified these 11 "new commercial" companies with one or two marketed products by the year that their first product was approved, again based on publicly-available information:
Most of the companies inspected in FY2023 had their first approvals in 2019 - 2021 - two to four years before they underwent their first PV inspection. (The dataset also allows us to verify that those companies did not have PV inspections before FY2023.) Note that we would expect most companies in this dataset to have their first approvals clustered in more recent years, simply because more mature sponsors would have more products on the market, kicking them out of this dataset, which is restricted to companies with one or two marketed products. What's interesting here is that no companies with first approval in 2022 were inspected in FY2023, and only two companies with first approval in 2021 were inspected. Three to four years post-approval appears to be the sweet spot.
Some caveats about these data points:
FDA may take any number of variables into account when selecting inspection targets.
These metrics consider only FY2023 inspections because this time frame allows us to gauge how many marketed products each company had at the time of inspection. FY2023 could have been an outlier - e.g., in earlier years, FDA may have conducted PV inspections of more or fewer "new commercial" companies. On the other hand, the pandemic may have permanently disrupted any established patterns anyway.
In summary, data are descriptive, not predictive, but a little bit of information is better than none.
