How do regulatory agencies justify their investments in regulatory science and innovation? An examination of FDA's congressional budget justifications

Regulatory science is critical to reduce uncertainty in the introduction of novel technological products, inducing innovation while promoting safety. However, due to the politization of science and the risks of regulatory capture, investments in regulatory science may face criticism and public scrutiny. We conduct an exploratory study to analyze how regulatory agencies justify their investments in regulatory science. We focus on the U.S. Food and Drug Administration. Our main data sources are sixteen of the agencies' budget requests, spanning the fiscal years from 2011 to 2026. We use qualitative content analysis techniques to observe patterns in word frequency, as the semantic framing of regulatory science activities, through the years. Our findings suggest that the agency has periodically changed the language used to frame regulatory science to align with the priorities of the elected government, but such semantic changes do not necessarily correspond to any real changes in the way they conduct regulatory science. Legislation and outsourcing are used to protect regulatory science activities. We propose a three-layer model to explain how regulatory agencies balance tensions between the technical and political aspects of regulatory science. • FDA reframes investments in regulatory science to soften political frictions • Rhetorical changes do not necessarily imply large changes in daily activities • Institutional buffers increase the resilience of regulatory science activities • We propose a three-layer model to balance technical and political forces