2023 is in the books, and JP Morgan 2024 has just wound down with a lot of positivity and buzz registered throughout the diverse audience. As we look ahead to what the FDA is doing—and will do—in 2024, it helps to begin by analyzing what just occurred in the industry in 2023 as far as regulatory compliance trends are concerned.

I’ll break down these data in relatively great detail, in order to help you better understand what’s going on, and how best to be armed for what will occur in 2024.

The following is a paired time-series plot of the number of Domestic (blue) and Foreign (fuchsia) inspections that occurred each month in 2023:

N.B.: The plot above includes only inspections for drugs and biologics.

If we dive a little deeper into the domestic inspection trend, and deconstruct it by month, we find that there was an average of 160 domestic inspections per month in 2023:


And an average of 59 foreign inspections per month in 2023:


Across all the drugs and biologics inspections in 2023, the following is a plot of the classification of each inspection by-month, where green is NAI (No Action Indicated), amber is VAI (Voluntary Action Indicated), and red is OAI (Official Action Indicated):


A trend analysis of NAI-classified inspections in 2023 (from the green trend line in the chart above) demonstrates that the number of inspections classified as NAI (No Action Indicated) is trending downward:


In fact, about two-thirds of the variation in the NAI inspection data is explained by timewise effects (advancing months through 2023):


Given these data, and a lack of corresponding trend in decreasing inspections per month, we may see fewer inspections in the future that will result in NAI categorization.

If we look at classification of inspections for biologics and drugs (below), we can see a relative breakdown by visual proportion of NAI, OAI, and VAI for each major category of therapy.

Citations and compliance trends

Let’s look at the Top 10 citations in 2023, and deconstruct the subsections from the Code of Federal Regulations from which they manifested:


Above shows the breakdown of the top 10 citation categories for 2023, which are:

19.3% – 98 instances – 21 CFR 211.22(d) – Procedures not in writing, fully followed
14.0% – 71 instances – 21 CFR 211.192 – Investigations of discrepancies, failures
10.8% – 55 instances – 21 CFR 211.100(a) – Absence of written procedures
10.2% – 52 instances – 21 CFR 211.160(b) – Scientifically sound lab controls
9.4% – 48 instances – 21 CFR 312.60 – 1572 Protocol compliance
9.1% – 46 instances – 21 CFR 211.67(a) – Cleaning/sanitizing/maintenance
7.7% – 39 instances – 211 CFR 211.63 – Equipment design, size, and location
7.3% – 37 instances – 21 CFR 211.68(b) – Computer control of master formula records
6.7% – 34 instances – 21 CFR 1271.75(a)(1) – Human tissue for transplantation, risk factors, clinical evidence
5.5% – 28 instances – 21 CFR 211.113(b) – Procedures for sterile drug products

The percentages for each element above are the representative proportions each of the top 10 issues were cited during inspections in 2023.

And finally, the following choropleth map shows a breakdown of where the 1,921 domestic inspections occurred throughout 2023 by region:

What will 2024 bring?

Calendar year 2024 is off to a strong start, both within the industry and associated investments (such as the XBI biotech index), and within the FDA and their inspection regime. Certain inspection and compliance factors will be keyed-in upon based upon their relative frequency in 2023, as well as new architecture to the inspection data based on what the inspectors are experiencing in both first-time as well as follow-up inspections. NAIs will likely continue to trend downward as a proportion of overall inspections in 2024, and smaller and mid-sized companies being inspected for novel therapeutics are likely to incur citations against the fundamentals of cGMP, as well as perhaps more exotic citations.

I’d encourage you to re-read the breakdown table of the top-10 citations above and understand that some of these citations are the very basics, and the ones which show up on FDA “citation trends” lists year after year. As the saying goes, “Past behavior is the best predictor of future performance.” However, it’s not a guarantee. But as industry super forecasters know, using more high-quality and recent data leads to better overall predictive outcomes. Be better prepared for your future in 2024.

Source
US Food & Drug Administration. (2024). Inspections. https://datadashboard.fda.gov/ora/cd/inspections.htm

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Ben Locwin writes the Clinically Speaking column for Contract Pharma and is an industry executive and healthcare futurist. He has worked with a number of the top pharma companies, in addition to chairing and keynoting over a hundred industry conferences. He has been featured in Forbes, The Wall Street Journal, USA Today, NPR, Axios, The Associated Press, and other top-tier media.