title: Neoliberal technocracy: explaining how and why the US Food and Drug Administration has championed pharmacogenomics.
abstract: By 2004 the FDA had emerged as a champion of pharmacogenomics as an exemplar for novel approaches to drug development. This was made clear in 2004 when the agency released a wide-ranging report which positioned pharmacogenomics at the heart of a broader regulatory reform agenda. The Critical Path initiative addressed declining productivity of drug development by suggesting that the problem was a mismatch between the rapid pace of discovery in post-genomic biomedicine and the antiquated development process for new drugs. Framing their work in this context, FDA officials reconceptualised their role in the innovation process, in what was the first programmatic statement of a shift from a strictly gate-keeping role to a more collaborative or facilitative role as enablers of innovation. This paper situates the FDA's emergence as a champion of pharmacogenomics in the broader politics of pharmaceutical regulation in the USA. In making a contribution to the pharmaceuticalisation literature this paper will draw on the work of John Abraham who has argued that one of the primary drivers of pharmaceuticalisation has been "deregulatory state policies" and on Williams and colleagues who have argued that the changing relationship between regulatory agencies and the pharmaceutical industry is an important dimension of pharmaceuticalisation. This paper links this to the promotion of pharmaceutical futures such as pharmacogenomics and explores how this shift is also closely related to the trend towards a risk management approach to pharmaceutical regulation. The role of Bush appointees in the development and promotion of the Critical Path agenda is also examined.
authors: Department of Social Science and Medicine, King's College London, Strand Campus, The Strand, London WC2R 2LS, UK. Electronic address: stuart.hogarth@kcl.ac.uk.
authors: Stuart
authors: S
authors: Hogarth
mesh_terms: D055808:Drug Discovery / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational; D020793:Gatekeeping / Q000331:legislation & jurisprudence; D062069:Inventions / Q000331:legislation & jurisprudence; D010597:Pharmacogenetics; D011057:Politics; D057285:Precision Medicine; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D015507:Drugs, Investigational
keywords: Bioeconomy; FDA; Neoliberalism; Personalised medicine; Pharmaceutical regulation; Pharmacogenomics; Technocracy; USA