| 来源类型 | Working Paper |
| 规范类型 | 报告 |
| DOI | 10.3386/w28889 |
| 来源ID | Working Paper 28889 |
| Regulatory Approval and Expanded Market Size | |
| Benjamin Berger; Amitabh Chandra; Craig Garthwaite | |
| 发表日期 | 2021-06-07 |
| 出版年 | 2021 |
| 语种 | 英语 |
| 摘要 | Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality certification. We combine data on FDA approvals for follow-on indications and patient-level data on utilization, and examine whether FDA approval of a follow-on indication increases the use of a drug for that indication. We find 5 facts for the market-expanding role of regulation: (1) follow-on approvals increase the share of patients taking a drug with that indication by 4.1 percentage points, or 40% increase over baseline use, at the time of approval; (2) there is little market learning prior to or following the approval of the follow-on indication, suggesting that such approvals fully certify the new use; (3) the effect of these approvals is larger for uses in a different disease area than previous indications, an increase equivalent to over 4 ½ years of market-learning; (4) it is FDA approval, not the initiation of clinical trials that generate the expansion in market size; (5) the market expansion is consistent with physicians prescribing the medicines more because of higher perceived benefits, not reduced administrative costs. |
| 主题 | Health, Education, and Welfare ; Health ; Development and Growth ; Innovation and R& ; D |
| URL | https://www.nber.org/papers/w28889 |
| 来源智库 | National Bureau of Economic Research (United States) |
| 引用统计 | |
| 资源类型 | 智库出版物 |
| 条目标识符 | http://119.78.100.153/handle/2XGU8XDN/586563 |
| 推荐引用方式 GB/T 7714 | Benjamin Berger,Amitabh Chandra,Craig Garthwaite. Regulatory Approval and Expanded Market Size. 2021. |
| 条目包含的文件 | ||||||
| 文件名称/大小 | 资源类型 | 版本类型 | 开放类型 | 使用许可 | ||
| w28889.pdf（644KB） | 智库出版物 | 限制开放 | CC BY-NC-SA | 浏览 | ||
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