Rhetoric, Ethics, and Health Identities in the FDA's Drug Approval Process

Abstract

This dissertation examines how health identities are rhetorically constructed and discursively taken up in the FDA’s new drug application (NDA) documents. The project specifically focuses on approval processes related to three HIV intervention medications (i.e., Retrovir, Combivir, and Stribild) and four FDA NDA documents (i.e., medical officer’s review, memo, drug approval letter, and drug labeling document). Informed by scholarship in rhetorics of health and medicine, rhetorical genre studies, and ethics of care, I conducted a qualitative analysis to examine how health identities get instantiated through discursive labels and categories, how the FDA functions as gatekeepers in the regulatory process, and how tensions in caring manifests in clinical trial research practices. Findings from this study show how NDA texts shape drug safety and efficacy decision-making practices; the analysis reveals, further, that FDA reviewers and drug sponsor researchers deploy language that stereotypes and stigmatizes individuals living with HIV who are in need of HIV medication. Ultimately, in examining how individuals get ascribed into specific health status groups (e.g., healthy versus infected, high-risk patients versus healthy patients), this dissertation demonstrates how discourse practices in the NDA process reinforce and normalize identity constructs in public health policy and regulatory practices.