Regulatory Data!? Who Cares?

What is regulatory data? It sounds ultra-niche; this has no impact on me! I see these comments through the faces of the many people I champion in my recent research. However, last month, I had the profound opportunity to speak on regulatory data to a group that is in tune with what I do!

But before diving into the content and impact of the talk, let’s first answer the general question initially posed: What even is regulatory data, and how does it impact me?

Regulatory data is a broad term but is generally used in the life science industry to capture the scope of content and data that falls under either compliance with an agency or approval of a product with an agency…

I am getting a drug to market or keeping it in the market. Both of these functions have oversight.

The reason for care is more nuanced and under even more recent scrutiny ahead of organizational and administrative changes at the Food and Drug Administration(FDA). However, the reason to care is that companies drive genuine change because of regulation.

These are some of the topics and points I made in my recent talk at The International Society for Pharmaceutical Engineering(ISPE) National Conference in Orlando. I was also able to dive deep into FDA warning letters and statistics related to this particular enforcement tool, particularly with newfound methods of analyzing content using modern technologies and techniques.

What are these new methods and techniques?

AI is a particular topic, not just in the generative model space but particularly in document reading and classification. The cost per document and ability to store, categorize, and parse through information has improved to a level that consistent manual work and modern tech are about equipment in accuracy. While the largest and most resourceable firms have been able to captivate technology and methods for mass document storage for years, it is becoming increasingly apparent.

Small and middle-market organizations will have to adopt new technologies to continue with market advancement.

A great example of the need for greater advancement and technological adoption is the FDA’s issuance of severe violations. Warning Letters are one such document that assists the agency in enforcing compliance actions.

Above is a display of inspection and warning letter data for 2019 to 2023. The total quantity of each can be compared, as warning letters are generally issued following an inspection. Upon doing so, the ratio to which warning letters have been issued in recent years can be clearly seen. There is a clear increase in this ratio, hinting that agency citations may be overall increasing.

While extrapolating by firm size can be difficult, it is important to note there is only a set number of firms that are particularly large, so a rapid increase in citations may be more relevant to a medium or average than a small subsection.

Overall, bringing better tools forward to firms struggling with consistent citations is one quick way to ease a potential problem for the industry. By allowing for better dissemination and understanding of the documents a firm owns and contains, more awareness can be had around critical issues and validations.