Working Paper: NBER ID: w30712
Authors: Amitabh Chandra; Jennifer Kao; Kathleen L. Miller; Ariel D. Stern
Abstract: Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to innovate around this tradeoff—i.e., whether it improved regulator productivity by allowing products to come to market more quickly without compromising quality. 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. In exploring mechanisms, we find that the BTD program had the greatest impact on less experienced firms and was associated with reduced BTD clinical trial design complexity. The results suggest that targeted regulatory innovation can shorten R&D periods without compromising the quality of new products.
Keywords: No keywords provided
JEL Codes: I10; I18
Edges that are evidenced by causal inference methods are in orange, and the rest are in light blue.
| Cause | Effect |
|---|---|
| FDA's Breakthrough Therapy Designation (BTD) (O30) | drug safety (J28) |
| FDA's Breakthrough Therapy Designation (BTD) (O30) | clinical trial design complexity (C90) |
| FDA's Breakthrough Therapy Designation (BTD) (O30) | faster access to medicines (I18) |
| faster clinical development (O36) | adverse event rates (C22) |
| FDA's Breakthrough Therapy Designation (BTD) (O30) | shortened clinical development times (C41) |