Abstract
AbstractPharmacogenetic tests provide genetic data to tailor drug treatment and were widely predicted to be one of the first fruits of the Human Genome Project. In the mid‐2000s, the US Food and Drugs Administration (FDA) became an advocate for pharmacogenetic testing, but its efforts to build a market for this new technology brought the agency into dispute with other regulatory actors over the type of evidence needed for the adoption of pharmacogenetic testing, in particular the importance of randomized control trials. The warfarin case highlights the tension between a new form of promissory regulation driven by future expectations and FDA's established role as protector of public health; and the controversy can be conceptualized as a struggle over regulatory epistemologies within a complex polycentric regulatory space. Our case study addresses two themes central to the burgeoning scholarship on the governance of emergent science and technologies (EST): the political economy of regulation, in particular the role that regulators play in creating markets for EST; and the epistemological politics of regulatory science, in particular the controversy that arises when regulators modify scientific standards to accommodate EST. Linking these two themes is the concept of promissory regulation: the idea that regulatory policy may be shaped by an institutional commitment to the transformational potential of EST. This concept sheds new light on the neo‐mercantilist nature of contemporary regulatory capitalism.
Highlights
We argue that Food and Drugs Administration (FDA)’s promotion of pharmacogenetics manifested the agency’s transformation from gatekeeper to enabler of innovation and its advocacy was a form of promissory regulation
The warfarin controversy can be understood as reflecting important tensions that arise from two distinct modes of risk governance that are captured in Majone’s model of the regulatory state and Mazucatto’s model of the entrepreneurial state (Majone, 1997; Mazzucato, 2014)
When it took on a new role as an enabler of innovation, it was functioning as part of the entrepreneurial state with a much greater emphasis on risk-taking
Summary
“The ratio of vision to data is very high...We love vision, but data is our mainstay.” Jerry Collins, Director of the Laboratory of Clinical Pharmacology, US Food and Drugs Administration (FDA). (Hodgson & Marshall, 1998) “This first decade of the 21st century began with the decoding of the human genome—a scientific achievement that we knew had the potential to transform our understanding of health and disease and revolutionize our fundamental approach to medicine.” Margaret Hamburg, FDA Commissioner, 2010. (Hamburg, 2010). The ratio of vision to data: The FDA and promissory regulation politics of regulatory science, in particular the controversy that arises when regulators modify scientific standards to accommodate EBT. By 2004, the largest regulatory agencies governing the development and use of new medicines – the US Food and Drugs Administration (FDA) and the European Medicines Agency (EMA) – had added their voices to the chorus Much of this genomic hope was focused on pharmacogenetics: improving the safety and efficacy of treatment by using genetic tests to predict how individuals will respond to pharmaceuticals. We argue that FDA’s promotion of pharmacogenetics manifested the agency’s transformation from gatekeeper to enabler of innovation and its advocacy was a form of promissory regulation This new role entailed not the promotion of pharmacogenetics as a new form of regulatory science, but advocacy for specific clinical applications of this approach. The warfarin controversy offers new insights into how regulatory agencies are reconceptualizing their role in the biomedical innovation system; how their power is legitimated by regulatory epistemologies, and the diffuse networks of power operating in the regulatory space
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