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

• 成果类型: Article
• 署名作者: Chandra, Amitabh; Kao, Jennifer; Miller, Kathleen L.; Stern, Ariel D.
• 署名单位: Harvard University; National Bureau of Economic Research; University of California System; University of California Los Angeles; Harvard University
• 刊物名称: REVIEW OF ECONOMICS AND STATISTICS
• ISSN/ISSBN: 0034-6535
• DOI: 10.1162/rest_a_01434
• 发表日期: 2026
• 关键词: drug development; product recalls; APPROVAL; industry; BENEFIT

摘要

Regulators of new products confront a trade-off 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 trade-off. We find that the BTD program shortened clinical development times by 23% and did not affect 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.