The political logic of regulatory error

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.

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. 1

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

    CAS  Article  Google Scholar 

  2. 2

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

    Article  Google Scholar 

  3. 3

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

    Article  Google Scholar 

  4. 4

    Carpenter, D. P. & Ting, M. M. Regulatory error under two-sided uncertainty (unpublished manuscript, Department of Government, Harvard University; circulated as Robert Wood Johnson Scholars in Health Policy Program Working Paper #30) (2005).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

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

    Google Scholar 

  6. 6

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

    Article  Google Scholar 

  7. 7

    Carpenter, D. P., Chernew, M., Fendrick, A. M. & Smith, D. Approval times for new drugs: does the source of funding for FDA staff matter?' Health Affairs (web exclusive), W3-618–624 (2003).

  8. 8

    Psaty, B. M., Furberg, C. D., Ray, W. A., Weiss, N. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA 292, 2630 (2004).

    Google Scholar 

  9. 9

    Wood, A. J., Stein, C. M. & Woosley, R. Making medicines safer: the need for an independent drug safety board. N. Engl. J. Med. 339, 1851–1854 (1998).

    CAS  Article  Google Scholar 

  10. 10

    Senator Charles Grassley, remarks on 'Food and Drug Administration' radio programme. Diane Rehm Show [online audio], <http://www.wamu.org/audio/dr/04/11/r1041123.ram> (23 November 2004).

  11. 11

    Wardell, W. & Lasagna, L. Regulation and Drug Development (American Enterprise Institute, Washington DC, 1975).

    Google Scholar 

  12. 12

    Graham, D. FDA, Merck and Vioxx: putting patient safety first? [online], <http://finance.senate.gov/hearings/testimony/2004test/111804dgtest.pdf>

  13. 13

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

    Google Scholar 

  14. 14

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

    Google Scholar 

  15. 15

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

    Article  Google Scholar 

Download references

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.

Author information

Affiliations

Authors

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Related links

Related links

FURTHER INFORMATION

Center for Drug Evaluation and Research

FDA Homepage

Office of Drug Safety

Rights and permissions

Reprints and Permissions

About this article

Cite this article

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

Download citation

Further reading

Search

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing