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Strategic Submissions : A Cross-Country Analysis of Supplemental Drug Approvals

Author

Listed:
  • 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])

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.

Suggested Citation

  • Pierre Dubois & Elissa Gentry & Tuba Tunçel, 2025. "Strategic Submissions : A Cross-Country Analysis of Supplemental Drug Approvals," Working Papers hal-05117280, HAL.
    • Handle: RePEc:hal:wpaper:hal-05117280
    Note: View the original document on HAL open archive server: https://hal.science/hal-05117280v1
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