The paper argues that scholars in rhetoric of science have an important role to play in the emerging interdisciplinary field of regulatory science. Focused on protecting public health through regulation of medicines, scholars in regulatory science work to bridge the high epistemic demands of academic science and the practical policy aims in “real-world” regulation of drugs. The field aims to develop frameworks and values that support decision-makers in managing drug-related uncertainties and risks under strict legal, time and budgetary constraints (Todt et.al, 2010). This requires a thorough rhetorical understanding of the establishment of scientific ethos and argumentation practices (Prelli, 1989) in the regulatory circuit of industry, academia and authorities. The paper includes a rhetorical analysis of an example from the Danish healthcare sector.

The paper is part of a PhD project about the rhetoric of regulatory science in the Danish healthcare system. In Denmark, as in the rest of the EU, policy makers and regulators are met with increasing demands for science-based decisions. As medicines are becoming more complex, regulatory bodies and pharmaceutical companies are increasingly required to address public health concerns about long term risks with scientifically sound knowledge that allows for a continuous re-evaluation of the risk-benefit balance of a drug. However, the real-world circumstances of regulating medicine challenge the relevance and impact of “academic” scientific knowledge. A conventional, scientific investigation and assessment might not effectively absolve the uncertainty regarding a potential risk due to the strict time and budgetary limitations.

Oliver Todt, Javier Rodríguez Alcázar & José Luis Lujá. “Practical Values and Uncertainty in Regulatory Decision‐making.” Social Epistemology 24:4 (2010): 349-362.

Prelli, Lawrence J. A Rhetoric of Science: Inventing Scientific Discourse. Columbia: University of South Carolina Press, 1989.