Evolution or erosion? Promissory discourses in ‘accelerated’ regulatory approval of health technologies

In recent years, regulatory processes governing the approval of new health technologies have undergone changes aimed at expediting access. Some of these changes involve the adaptation of established standards of evidence for safety and efficacy, which we refer to as evidence-adapted regulatory pathways (EARPs). While EARPs have provided more timely access to potentially beneficial interventions, critics argue that reducing evidentiary thresholds threatens regulatory integrity, compromises safety, and undermines evidence-based medicine. In this article, we argue that regulatory processes and the therapeutic choices they enable are deeply socially constructed, and that discourse—particularly promissory discourse—plays a constitutive role in shaping regulation and its outcomes. We offer a typology of existing pathways to access health technologies, examine the growth of EARPs internationally and identify some recurring themes in the associated scholarly and public-facing discourses. We show that EARPs are often portrayed in a ‘promissory’ manner that obscures risks and uncertainties. We argue that this promissory discourse can (i) distort patients’ and clinicians’ understandings of evidence and decisions about clinical use and (ii) create undue pressure on funders. We suggest avenues for further research and policy development that could help regulators, in collaboration with clinicians and consumers, to promote socially responsible discourse around EARPs.