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Interpellative Sociology of Pharmaceuticals: Problems and Challenges for Innovation and Regulation in the 21st Century

Abraham, John ; Davis, Courtney

Technology analysis & strategic management, 2007-05, Vol.19 (3), p.387-402 [Periódico revisado por pares]

Abingdon: Routledge

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  • Título:
    Interpellative Sociology of Pharmaceuticals: Problems and Challenges for Innovation and Regulation in the 21st Century
  • Autor: Abraham, John ; Davis, Courtney
  • Assuntos: Biotechnology ; Business studies ; Economic sociology ; Innovation ; Innovations ; Pharmaceutical industry ; Pharmaceuticals ; Public access ; Regulation ; Regulatory agencies ; Regulatory policy ; Safety standards ; Science and technology ; Sociology ; Studies
  • É parte de: Technology analysis & strategic management, 2007-05, Vol.19 (3), p.387-402
  • Notas: ObjectType-Article-2
    SourceType-Scholarly Journals-1
    ObjectType-Feature-1
    content type line 23
  • Descrição: This paper develops a framework with which to interrogate how well pharmaceutical innovation and regulation are performing to produce drugs that improve health. That framework comprises five key dimensions: therapeutic advance of drug product innovations; safety standards in drug testing; use of surrogate measures of clinical benefit; independence of regulatory agencies; and public access to regulatory science. It is concluded that: more demanding regulatory intervention is required in order to increase the proportion of drug innovation that actually offers therapeutic benefits over existing products; drug regulatory agencies need much greater independence from the pharmaceutical industry; the erosion of safety standards since 1990 needs to be reversed; accelerated approvals of drugs based on surrogate, rather than clinical endpoints, require much greater critical attention; and much more extensive public access to regulatory science is required in order for regulatory decision-making to be thoroughly accountable to the public and the wider scientific community.
  • Editor: Abingdon: Routledge
  • Idioma: Inglês
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