Off-label drug use is common, particularly in pediatric populations. In response, legislation requires and/or provides financial incentives for drug manufacturers to perform pediatric clinical trials. Using New Hampshire’s all-payer claims database, we examine the impact of subsequent changes to drug labeling on pediatric drug utilization. To separate changes in utilization induced by labeling changes from other temporal factors, we estimate difference-in-differences models that compare utilization trends for pediatric patients to those of adults. We estimate that establishing safety and efficacy increases a drug’s market share by (a statistically significant) 2.8 percentage points, whereas failure to do so decreases a drug’s market share by (a statistically insignificant) 0.9 percentage points. We then interpret these estimates within the context of public and market incentives to conduct pediatric clinical trials.

中文翻译：

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谁在乎标签？儿科标签变化对处方药利用率的影响。

标签外使用毒品很普遍，尤其是在儿科人群中。作为回应，立法要求和/或为药物制造商提供经济激励以进行儿科临床试验。使用新罕布什尔州的全付款人索赔数据库，我们检查了药品标签后续更改对儿科药物利用的影响。为了将标记变化引起的利用率变化与其他时间因素分开，我们估计了差异模型，该模型比较了小儿患者和成年人的利用率趋势。我们估计，建立安全性和有效性会使药物的市场份额增加（统计上显着）2.8个百分点，而未能做到的话会使药物的市场份额减少（统计上不显着）0.9个百分点。