 Regulating ethical experimentation: Impacts of the breakthrough therapy designation on drug R&DManuel Hermosilla Journal of Health Economics, 2024, vol. 94, issue C Abstract: This article investigates patterns of pharmaceutical development activity around the 2012 creation of the FDA’s Breakthrough Therapy Designation (BTD). The BTD introduced regulatory flexibility and support to avoid ethical challenges created by experimental therapies of exceptional performance in early stage clinical trials. We argue that the program’s design indirectly created substantial incentives for the industry to pursue the designation. Consistent with this hypothesis, our evidence links the creation of the program with a substantial increase in the number of new drug indications entering the clinical trial process. This surge in introductions has resulted in a discernible increase in approvals, which has manifested with a lag and may strengthen in the future. Countering theoretical predictions, BTD incentives have not led to increased risk taking in project selection. Keywords: Pharmaceuticals; R&D; Technological change; Ethics; FDA; Regulation (search for similar items in EconPapers) Downloads: (external link) Related works: Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text Persistent link: https://EconPapers.repec.org/RePEc:eee:jhecon:v:94:y:2024:i:c:s0167629623001327 DOI: 10.1016/j.jhealeco.2023.102855 Access Statistics for this article Journal of Health Economics is currently edited by J. P. Newhouse, A. J. Culyer, R. Frank, K. Claxton and T. McGuire More articles in Journal of Health Economics from Elsevier |
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