Assessing Perspectivalism in Patient Participation: An Evaluation of FDA Patient and Consumer Representative Programs

Abstract

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.