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The political logic of regulatory error

Nature Reviews Drug Discovery volume 4, pages 819–823 (2005)Cite this article

Abstract

Regulatory error is an issue that has come to the fore following the withdrawal of rofecoxib (Vioxx; Merck) a year ago. Here, we provide a theoretical discussion of the factors that could influence regulatory error, drawing on the Vioxx episode in particular as a possible example of error, and consider the implications for future regulatory policy.

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Acknowledgements

Professors Carpenter and Ting acknowledge Harvard University, the National Science Foundation and an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation (Carpenter) for support of this research. Professors Carpenter and Ting neither seek nor accept funding from the FDA or from commercial entities such as pharmaceutical companies that sponsor product applications to the FDA. We thank three anonymous reviewers for helpful comments.

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Authors and Affiliations

  1. Department of Government, 1737 Cambridge St, CGIS N405, Harvard University, Cambridge, 02138, Massachusetts, USA

    Daniel Carpenter

  2. Department of Political Science, International Affairs Building, Floor 7, 420 West 118th Street, New York, 10027, New York, USA

    Michael M. Ting

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  1. Daniel Carpenter
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  2. Michael M. Ting
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Carpenter, D., Ting, M. The political logic of regulatory error. Nat Rev Drug Discov 4, 819–823 (2005). https://doi.org/10.1038/nrd1850

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