创新的监管激励：美国食品和药物管理局的突破性疗法认定

IF 7.6 1区经济学 Q1 ECONOMICS

Review of Economics and Statistics Pub Date : 2024-03-18 DOI:10.1162/rest_a_01434

Amitabh Chandra, Jennifer Kao, Kathleen L. Miller, Ariel D. Stern

{"title":"创新的监管激励：美国食品和药物管理局的突破性疗法认定","authors":"Amitabh Chandra, Jennifer Kao, Kathleen L. Miller, Ariel D. Stern","doi":"10.1162/rest_a_01434","DOIUrl":null,"url":null,"abstract":"\n Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to innovate around this tradeoff. We find that the BTD program shortened clinical development times by 23 percent and did not impact the ex post safety profile of drugs with the designation. The BTD program had the greatest impact on less experienced firms and reduced clinical trial design complexity. The results suggest that targeted regulatory innovation can shorten R&D periods without compromising product quality.","PeriodicalId":48456,"journal":{"name":"Review of Economics and Statistics","volume":null,"pages":null},"PeriodicalIF":7.6000,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation\",\"authors\":\"Amitabh Chandra, Jennifer Kao, Kathleen L. Miller, Ariel D. Stern\",\"doi\":\"10.1162/rest_a_01434\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"\\n Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to innovate around this tradeoff. We find that the BTD program shortened clinical development times by 23 percent and did not impact the ex post safety profile of drugs with the designation. The BTD program had the greatest impact on less experienced firms and reduced clinical trial design complexity. The results suggest that targeted regulatory innovation can shorten R&D periods without compromising product quality.\",\"PeriodicalId\":48456,\"journal\":{\"name\":\"Review of Economics and Statistics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":7.6000,\"publicationDate\":\"2024-03-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Review of Economics and Statistics\",\"FirstCategoryId\":\"96\",\"ListUrlMain\":\"https://doi.org/10.1162/rest_a_01434\",\"RegionNum\":1,\"RegionCategory\":\"经济学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ECONOMICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Review of Economics and Statistics","FirstCategoryId":"96","ListUrlMain":"https://doi.org/10.1162/rest_a_01434","RegionNum":1,"RegionCategory":"经济学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ECONOMICS","Score":null,"Total":0}

引用次数: 0

摘要

新产品的监管者需要在加快产品上市速度和收集更多产品质量信息之间做出权衡。美国食品及药物管理局的突破性疗法认定（BTD）提供了一个机会，让我们了解监管机构能否利用新政策在这一取舍之间进行创新。我们发现，BTD 计划将临床开发时间缩短了 23%，并且不会影响获得指定药物的事后安全性。BTD 计划对经验不足的公司影响最大，并降低了临床试验设计的复杂性。结果表明，有针对性的监管创新可以缩短研发时间，同时不影响产品质量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to innovate around this tradeoff. We find that the BTD program shortened clinical development times by 23 percent and did not impact the ex post safety profile of drugs with the designation. The BTD program had the greatest impact on less experienced firms and reduced clinical trial design complexity. The results suggest that targeted regulatory innovation can shorten R&D periods without compromising product quality.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Review of Economics and Statistics Multiple-

CiteScore

8.50

自引率

0.00%

发文量

175

期刊介绍： The Review of Economics and Statistics is a 100-year-old general journal of applied (especially quantitative) economics. Edited at the Harvard Kennedy School, the Review has published some of the most important articles in empirical economics.