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Progress, innovation and regulatory science in drug development: the politics of international standard-setting
journal contributionposted on 2023-06-07, 20:49 authored by John Abraham, Tim Reed
This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and `progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of `technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the `technical trajectories' of regulatory science.
JournalSocial Studies of Science
Department affiliated with
- Sociology and Criminology Publications
NotesBased on ESRC-funded international empirical research (ESRC Ref L323253020), this is the first article to use a sociology of science approach to examine in detail the relationships (or lack of) between therapeutic progress, pharmaceutical innovation and regulatory science, and to systematically scrutinise the validity of the claims made by the key actors involved about those relationships in pharmaceutical toxicology. As a result of this publication, Abraham gave an invited, plenary lecture to the European Congress of Toxicology, Amsterdam on 9 October 2007. Reed collected data, both authors undertook literature reviews, analysed data; Abraham wrote the paper.
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