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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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.
The authors declare no competing financial interests.
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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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