Regulatory Intermediaries in Commercially-Driven Prenatal Screening

• In Event: Corporate Influence on Science and Regulation – III

Abstract

Enthusiasm for so-called “personalized” or “precision” medicine has encouraged the growth of the molecular diagnostics industry and the proliferation of high priced proprietary tests that can predict, diagnose or inform the treatment of diverse clinical conditions. These tests are emerging with weak statutory regulation governing access to the market, and a diffuse array of (public and private) regulatory actors governing insurance coverage and reimbursement. In this context, regulatory intermediaries become essential actors in the commercialization and adoption of diagnostics. We build on work highlighting the importance of intermediaries in the construction and operation of diffuse regulatory regimes (Abbott et al 2017, Demortain 2017, Meyer and Kearnes 2013). We explore how regulatory intermediaries advise commercial diagnostics manufacturers on the adoption of their products using as a case study the highly profitable world of non-invasive prenatal testing (NIPT). NIPT is a largely unregulated test for fetal conditions like Down Syndrome that has achieved widespread global uptake. Through interviews and ethnographic fieldwork, we examine the way that private consultants, key opinion leaders and industry consortiums help NIPT companies sell their products by acting as regulatory intermediaries in the commercialization and distribution of this test. We draw on the “new political sociology of science” to develop a theoretical understanding of the role of intermediaries in this complex regulatory regime. We argue that these intermediaries both interpret and shape regulatory pathways, mobilizing evidence to enable product adoption in the interests of their clients in the context of neoliberal ‘re-regulation,’ commercialization and personalized medicine.

Authors

• Kelly Holloway, University of Toronto

• Fiona A. Miller, University of Toronto

• Nicole Simms, University of Toronto