The ratio of vision to data: Promoting emergent science and technologies through promissory regulation, the case of the FDA and personalised medicine
| Autor: | Stuart Hogarth, Paul Martin |
|---|---|
| Přispěvatelé: | Hogarth, Stuart [0000-0001-6796-8815], Apollo - University of Cambridge Repository |
| Rok vydání: | 2021 |
| Předmět: |
Medical education
4807 Public Law Public Administration Sociology and Political Science business.industry law.invention 4803 International and Comparative Law Randomized controlled trial law Medicine Personalized medicine Generic health relevance 4407 Policy and Administration business Law Pharmacogenetics 44 Human Society 48 Law and Legal Studies |
| Popis: | Pharmacogenetic 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 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 conceptualised 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 EBT. 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. |
| Databáze: | OpenAIRE |
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