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The political logic of regulatory error

Nature Reviews Drug Discovery volume 4, pages 819823 (2005) | Download Citation

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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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References

  1. 1.

    A Close inspection of the calm look. J. Am. Med. Assoc. 239, 2004–2011 (1978).

  2. 2.

    Groups, the media, agency waiting costs and fda drug approval. Am. J. Political Sci. 46, 490–505 (2002).

  3. 3.

    Protection without capture: dynamic product approval by a politically responsive, learning regulator. Am. Political Sci. Rev. 98, 613–631 (2004).

  4. 4.

    & Regulatory error under two-sided uncertainty (unpublished manuscript, Department of Government, Harvard University; circulated as Robert Wood Johnson Scholars in Health Policy Program Working Paper #30) (2005).

  5. 5.

    Protecting America's Health: The FDA, Business and One Hundred Years of Regulation (Knopf, New York, 2003).

  6. 6.

    The political economy of FDA drug approval: processing, politics and lessons for policy. Health Affairs 23, 52–63 (2004).

  7. 7.

    , , & Approval times for new drugs: does the source of funding for FDA staff matter?' Health Affairs (web exclusive), W3-618–624 (2003).

  8. 8.

    , , , Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA 292, 2630 (2004).

  9. 9.

    , & Making medicines safer: the need for an independent drug safety board. N. Engl. J. Med. 339, 1851–1854 (1998).

  10. 10.

    Senator Charles Grassley, remarks on 'Food and Drug Administration' radio programme. Diane Rehm Show [online audio], <> (23 November 2004).

  11. 11.

    & Regulation and Drug Development (American Enterprise Institute, Washington DC, 1975).

  12. 12.

    FDA, Merck and Vioxx: putting patient safety first? [online], <>

  13. 13.

    & Accelerating approval times for new drugs in the United States. The Regulatory Affairs J. Pharma. 15, 411–417 (2004).

  14. 14.

    Regulation of Pharmaceutical Innovation: The 1962 Amendments Washington: (American Enterprise Institute for Public Policy Research, Washington DC, 1974).

  15. 15.

    A strategic theory of bureaucratic redundancy. Am. J. Political Sci. 47, 274–292 (2003).

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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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Affiliations

  1. Daniel Carpenter is in the Department of Government, 1737 Cambridge St, CGIS N405, Harvard University, Cambridge, Massachusetts 02138, USA.  dcarpenter@latte.harvard.edu

    • Daniel Carpenter
  2. Michael M. Ting is in the Department of Political Science, International Affairs Building, Floor 7, 420 West 118th Street, New York, New York 10027, USA.  mmt2033@columbia.edu

    • Michael M. Ting

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Competing interests

The authors declare no competing financial interests.

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DOI

https://doi.org/10.1038/nrd1850

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