The Beginning of a "Regulatory Renaissance": Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support.

Abstract

Following the largest reorganization in its history, the U.S. Food and Drug Administration (FDA) is now working to modernize how it defines and engages in regulatory oversight of the quality of products that the agency regulates. However, the volume and complexity of these tasks, coupled with the size and interdependent nature of the global supply chains that generate and distribute these products, raise questions about how the agency can keep up with the pace of change. This dilemma, together with the FDA's recent reorganization, create an opportunity to rethink the FDA's strategy for regulatory coverage and usher in a "regulatory renaissance." In this article, we examine how the agency is working to develop a more quantitative, comprehensive approach to ensuring that the wide arrays of FDA-regulated commodities are produced and distributed in systems that meet societal expectations for safety and quality in a global digital environment. We discuss a number of tools and methods that the agency can bring to bear to achieve this goal, including leveraging internal FDA data and information from third-party audits; utilizing information from foreign regulators; incorporating data and findings from state and local inspections; and applying sophisticated data technologies including AI systems. The underlying concept for this regulatory renaissance is for the agency to focus on leveraging multiple sources of data, information, and analysis to inform its actions in order to optimize the quality of products produced by regulated industries, including the dimensions of safety, effectiveness, and reliability of manufacturing, as well as distribution and instructions for use throughout their product lifecycle. The degree of success of this approach will depend upon a broad recognition of similar opportunities across the regulated industries, sister federal and state agencies, and academia working on regulatory science.