Strategic Submissions: A Cross-Country Analysis of Supplemental Drug Approvals
Pierre Dubois,
Elissa Gentry and
Tuba Tunçel
Additional contact information
Pierre Dubois: TSE-R - Toulouse School of Economics - UT Capitole - Université Toulouse Capitole - UT - Université de Toulouse - EHESS - École des hautes études en sciences sociales - CNRS - Centre National de la Recherche Scientifique - INRAE - Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement
Elissa Gentry: Florida State University - FSU - Florida State University [Tallahassee]
Tuba Tunçel: Florida State University - FSU - Florida State University [Tallahassee]
Working Papers from HAL
Abstract:
Off-label use regulation has the potential to change pharmaceutical rms' behavior and|consequently|affect patient welfare. We investigate the impact of two changes in off-label regulation on pharmaceutical rms' behavior in seeking formal marketing approval for supplementary uses. In 2012, a US court decision protected truthful o-label promotion, providing pharmaceutical companies more leeway to promote o- label uses of their drug. Similarly, in 2011, France passed a new system for monitoring o-label uses in anticipation of formal approval. Using a unique data set of pharma- ceutical rms' research and development projects, we exploit these regulatory changes to understand how rms react to government policies. Results demonstrate that rms esponded to the US policy providing lower incentives to submit supplemental uses for formal approval. The results do not evince any reaction to France's stringent|but poorly enforced|regulation. These results have implications not only for innovation policy but for the creation of high-quality data for certain indications.
Keywords: Pharmaceutical firm behavior; Prescription drugs; Drug efficacy; Off-label drugs (search for similar items in EconPapers)
Date: 2025-06-17
Note: View the original document on HAL open archive server: https://hal.science/hal-05117280v1
References: Add references at CitEc
Citations:
Downloads: (external link)
https://hal.science/hal-05117280v1/document (application/pdf)
Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.
Export reference: BibTeX
RIS (EndNote, ProCite, RefMan)
HTML/Text
Persistent link: https://EconPapers.repec.org/RePEc:hal:wpaper:hal-05117280
Access Statistics for this paper
More papers in Working Papers from HAL
Bibliographic data for series maintained by CCSD ().