A public-oriented instrument to measure multidimensional bureaucratic power in medicine regulation

Background Understanding how the public perceives the power of medicine regulatory agencies is important for evaluating regulatory legitimacy, governance, and public trust. This study developed and conducted an initial validation of a survey instrument designed to measure perceived bureaucratic power of medicine regulatory agencies.Methods Drawing on Lukes’ theory of power, survey items reflecting directive, gatekeeping, and conceptual dimensions were developed and refined through expert consultation. A web-based survey of 1,000 South Korean adults was conducted using quota sampling by age, sex, and region. The psychometric properties of the instrument were evaluated using exploratory factor analysis, construct validity assessment, and internal consistency testing.Results Following expert review, the gatekeeping dimension was excluded because of concerns regarding its measurability in a general population survey. Exploratory factor analysis identified a two-factor structure consisting of directive and conceptual power. Construct validity was supported through convergent and discriminant validity testing, and both subscales demonstrated strong internal consistency (Cronbach’s α > 0.81). On a 100-point scale, the mean perceived power score was 74, with conceptual power rated higher (76) than directive power (72).Conclusion Respondents recognized both directive and conceptual dimensions of regulatory power. Regulatory power is perceived not only through direct enforcement but also through the shaping of public understanding and perceptions of regulation.