Expedited pathways in drug regulation: Evidence, uncertainty, and acceleration in biomedical innovation

Mathias Møllebæk

Chapter 22 in Handbook of Pharmaceutical Science and Technology Studies, 2026, pp 350-362 from Edward Elgar Publishing

Abstract: This chapter examines the workings and implications of expedited regulatory pathways in pharmaceutical governance through the lens of Science and Technology Studies. It argues that these pathways designed to accelerate access to medicines are not merely technical procedures but sociotechnical arrangements that actively shape what counts as evidence, innovation, and therapeutic value. The chapter briefly traces the historical and political origins of expedited pathways, including activist pressures during the HIV/AIDS crisis. Through detailed case studies, including the controversial approval of aducanumab and the revocation of bevacizumab's breast cancer indication, the chapter explores how expedited approvals redistribute evidentiary uncertainty, blur the lines between experiment and therapy, and produce conflicting realities of therapeutic benefit. These dynamics raise important ethical and political questions about patient risk, institutional authority, and the negotiation of evidence post-approval. Drawing on concepts such as market disentanglement, clinical labor, and ontological multiplicity, the chapter shows that regulatory decisions are not merely about scientific truth but about enacting particular versions of therapeutic reality. Ultimately, it calls for a more reflexive and socially attuned understanding of pharmaceutical regulation that can accommodate patient experience and accountability.

Keywords: Pharmaceutical regulation; Expedited approvals; Sociotechnical arrangements; Market access; Regulatory science (search for similar items in EconPapers)
Date: 2026
ISBN: 9781035338443
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