Recent research in rhetoric of health and medicine (RHM) has worked to evaluate the effectiveness of patient inclusion initiatives in health policy decision-making. Extending this line of research, this article evaluates the extent to which the U.S. Food and Drug Administration’s (FDA) patient and consumer representative programs meaningfully engage patient experiences. In so doing, this study provides directed and summative content analyses of pharmaceuticals policy deliberation at 163 FDA drug advisory committee meetings. The results indicate that the current implementation of the patient and consumer representative programs do not adequately ensure that patient experiences are being included as a part of advisory committee deliberation or subsequent pharmaceuticals policy. Additionally, the results presented support the growing concern that attempts to include patient perspectives in health policy may actually further marginalize patient populations.

This article pilots a study in statistical genre analysis, a mixed-method approach for (a) identifying conventional responses as a statistical distribution within a big data set and (b) assessing which deviations from the conventional might be more effective for changes in audience, purpose, or context. The study assesses pharmaceutical sponsor presentations at the Food and Drug Administration (FDA) drug advisory committee meetings. Preliminary findings indicate the need for changes to FDA conflict-of-interest policies.