Econ Papers Daily / 期刊论文
策略性提交：补充药物批准的分析
Strategic Submissions: An Analysis of Supplemental Drug Approvals
摘要
Off‐label use regulation has the potential to change pharmaceutical firms' behavior and—consequently—affect patient welfare. We investigate the impact of changes in off‐label regulation on pharmaceutical firms' behavior in seeking formal marketing approval for supplemental uses. In 2012, a US court decision protected truthful off‐label promotion, providing pharmaceutical companies more leeway to promote off‐label uses of their drug. Using a unique data set of pharmaceutical firms' research and development projects, we exploit this regulatory change to understand how firms react to government policies. Results demonstrate that the hazard of approval declined for supplemental uses, relative to original uses, after the policy change. Patent protection, potential market size, and competition are also important determinants of the hazard of approval. These results have implications not only for innovation policy but for the creation of high‐quality data for certain indications.
中文摘要
超说明书用药监管可能改变制药企业的行为，进而影响患者福利。本文研究了超说明书用药监管变化对制药企业寻求补充用途正式上市许可行为的影响。2012年美国一项法院裁决保护了真实的超说明书推广行为，使制药公司获得更大空间推广其药物的超说明书用途。我们利用制药企业研发项目的独特数据集，借助这一监管变化来理解企业如何应对政府政策。结果表明，政策变化后，补充用途相较于原始用途的获批风险有所下降。专利保护、潜在市场规模和竞争也是影响获批风险的重要因素。这些发现不仅对创新政策具有启示意义，也对特定适应症高质量数据的生成产生影响。