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

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  • Dubois, Pierre
  • Gentry, Elissa
  • Tuncel, Tuba

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 market- ing 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 responded 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

  • Dubois, Pierre & Gentry, Elissa & Tuncel, Tuba, 2023. "Strategic Submissions: A Cross-Country Analysis of Supplemental Drug Approvals," TSE Working Papers 23-1459, Toulouse School of Economics (TSE).
    • Handle: RePEc:tse:wpaper:128335
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    References listed on IDEAS

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    1. Iain M. Cockburn & Jean O. Lanjouw & Mark Schankerman, 2016. "Patents and the Global Diffusion of New Drugs," American Economic Review, American Economic Association, vol. 106(1), pages 136-164, January.
    2. Daron Acemoglu & Joshua Linn, 2004. "Market Size in Innovation: Theory and Evidence from the Pharmaceutical Industry," The Quarterly Journal of Economics, President and Fellows of Harvard College, vol. 119(3), pages 1049-1090.
    3. Pierre Dubois & Olivier de Mouzon & Fiona Scott-Morton & Paul Seabright, 2015. "Market size and pharmaceutical innovation," RAND Journal of Economics, RAND Corporation, vol. 46(4), pages 844-871, October.
    4. Elissa P. Gentry & Benjamin J. McMichael, 2020. "Responses to Liability Immunization: Evidence from Medical Devices," Journal of Empirical Legal Studies, John Wiley & Sons, vol. 17(4), pages 789-819, December.
    5. Yin, Wesley, 2009. "R&D policy, agency costs and innovation in personalized medicine," Journal of Health Economics, Elsevier, vol. 28(5), pages 950-962, September.
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