Essay: the political logic of regulatory error.
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.
Carpenter
Daniel
D
Department of Government, 1737 Cambridge St, CGIS N405, Harvard University, Cambridge, Massachusetts 02138, USA. dcarpenter@latte.harvard.edu
Ting
Michael M
MM
D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D007783:Lactones / Q000009:adverse effects / Q000627:therapeutic use; D008128:Logic; D015588:Observer Variation; D011057:Politics; D012107:Research Design / Q000706:statistics & numerical data*; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use
D007783:Lactones; D013450:Sulfones; C116926:rofecoxib