Off‐Label Use Of Pharmaceuticals: A Detection Controlled Estimation Approach
使用检测控制估计法，发现1993-2008年美国处方药超说明书使用率从29.9%升至38.3%，且与FDA批准替代品少、保险限制少及司法部诉讼有关，但医生处方模式似乎增进了患者福利。
We identify the rate of off‐label use of prescription drugs in the United States during 1993‐2008 using Detection Controlled Estimation. We find that the rate rises from 29.9% to 38.3% during this period. Off‐label prescribing increases when there are fewer FDA‐approved alternatives and a patient’s insurance has less restrictive formularies and lower copayments. The temporal increase in off‐label use coincides with a surge in settlements of Department of Justice (DOJ) lawsuits for off‐label marketing. Those drugs targeted by the DOJ have 4.6% higher rates of off‐label use initially, but the rate decreases 10.2% after the company becomes aware of the suit. The welfare effects of such regulatory intervention are unclear because we find off‐label prescribing patterns by physicians that are consistent with enhancement of patient welfare.