본문 바로가기

Conference Papers

board view
[The 9th AIEA-NBER Conference] Working Paper - Chandra Kao Miller Stern

NAME manager

DATE 2021.11.17 15:59

VIEW 21

REGULATORY INCENTIVES FOR INNOVATION:
THE FDA’S BREAKTHROUGH THERAPY DESIGNATION
 
Amitabh Chandra
Jennifer Kao
Kathleen L. Miller
Ariel D. Stern
 
AIEA Working Paper A210803  Issue date August 2021
 
 
In approving new medical products, regulators confront a tradeoff between speeding a new product to market
and collecting additional information about its quality. Alternatively, with the right allocation of resources, this
tradeoff function may be “shifted outward,” thereby allowing important products to come to market more quickly
without compromising quality evaluation. We study the FDA’s Breakthrough Therapy Designation (BTD), a
novel policy tool that was created to accelerate the clinical development and regulatory approval processes for
developers of high-value therapies by increasing feedback and communication with regulators during later phases
of drug development. Using algorithmic matching models, we assess the impact of the BTD program on measures
of (1) time-to-market and (2) post-approval drug safety. We find that the BTD program shortened late-stage
clinical development times by 24 percent. We do not find evidence of a difference in the ex post safety profile of
drugs with (vs. without) the BTD. In exploring mechanisms, we find support for reduced BTD trial design complexity,
but not for trial size as driving these findings. The results suggest that targeted policy tools can shorten
R&D periods without compromising the quality of new products.
다운로드표
File