Analyzing United States Prescribing Information to gain insight into FDA-sponsor discussions

Abstract

The United States Prescribing Information (USPI) is a key vehicle for communicating the benefit-risk information of a Food and Drug Administration (FDA) approved prescription drug. The USPI is typically the last step of the drug development process and requires discourse between the FDA and the sponsor for a new drug application. The USPI may also be updated after obtaining FDA approval. As a social artifact of industry and FDA discussions, it is hypothesized that an analysis of a library of USPI records may yield insight into this dialog. Here, an analysis of DailyMed – a USPI data repository – reveals that structural language similarities (linguistic typologies) exist across USPI. Interestingly, these typologies describe labeling language that may not be explicitly described in FDA regulatory documentation. It is proposed that the methodology herein proposed may be leveraged to potentially facilitate USPI development and FDA dialogue (and therefore expedite the drug development paradigm). Several examples are used to showcase the approach. A discussion on limitations of the methodology and opportunities for development is also presented.