Public Voices in Pharmaceutical Deliberations: Negotiating “Clinical Benefit” in the FDA’s Avastin Hearing

• DOI: 10.1007/s10912-014-9277-5
• Publication Date: 2014-03-31T01:33:11Z
• Authors: Christa B. Teston; S. Scott Graham; Raquel Baldwinson; Andria Li; Jessamyn Swift
• Keywords: Drug Industry; Negotiating; United States Food and Drug Administration; Breast Neoplasms; 02 engineering and technology; Antibodies, Monoclonal, Humanized; United States; 3. Good health; Bevacizumab; Humanities; Treatment Outcome; Public Opinion; 0202 electrical engineering, electronic engineering, information engineering; Humans; Drug Approval

This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.