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Neoliberal technocracy: Explaining how and why the US Food and Drug Administration has championed pharmacogenomics

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  • Hogarth, Stuart

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.

Suggested Citation

  • Hogarth, Stuart, 2015. "Neoliberal technocracy: Explaining how and why the US Food and Drug Administration has championed pharmacogenomics," Social Science & Medicine, Elsevier, vol. 131(C), pages 255-262.
  • Handle: RePEc:eee:socmed:v:131:y:2015:i:c:p:255-262
    DOI: 10.1016/j.socscimed.2015.01.023
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    References listed on IDEAS

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    1. Julia Black, 2005. "The Development of Risk-Based Regulation in Financial Services: Just ‘Modelling Through’?," Chapters, in: Julia Black & Martin Lodge & Mark Thatcher (ed.), Regulatory Innovation, chapter 8, Edward Elgar Publishing.
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    Cited by:

    1. Stuart Hogarth & Paul Martin, 2021. "The ratio of vision to data: Promoting emergent science and technologies through promissory regulation, the case of the FDA and personalised medicine," Regulation & Governance, John Wiley & Sons, vol. 15(3), pages 969-986, July.
    2. Sturdy, Steve, 2022. "Framing utility: Regulatory reform and genetic tests in the USA, 1989–2000," Social Science & Medicine, Elsevier, vol. 304(C).
    3. Cambrosio, Alberto & Campbell, Jonah & Keating, Peter & Polk, Jessica B. & Aguilar-Mahecha, Adriana & Basik, Mark, 2022. "Healthcare policy by other means: Cancer clinical research as “oncopolicy”," Social Science & Medicine, Elsevier, vol. 292(C).
    4. Gardner, John & Webster, Andrew, 2016. "The social management of biomedical novelty: Facilitating translation in regenerative medicine," Social Science & Medicine, Elsevier, vol. 156(C), pages 90-97.
    5. Erik Aarden & Luca Marelli & Alessandro Blasimme, 2021. "The translational lag narrative in policy discourse in the United States and the European Union: a comparative study," Palgrave Communications, Palgrave Macmillan, vol. 8(1), pages 1-9, December.

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