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Firm Characteristics and the Speed of FDA Approval

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  • Mary K. Olson

Abstract

This paper empirically examines the effect of firm‐specific characteristics on the length of time required by the Food and Drug Administration (FDA) to review and approve new‐drug applications between 1990 and 1992. The approach treats regulatory decisions as endogenous and explains the variation in regulatory behavior as a function of differences that exist between firms and drugs. Results show that, controlling for drug‐specific characteristics, regulators respond to firm‐specific characteristics when evaluating new drug applications. For instance, firms that are less diversified and more R&D‐inten‐sive receive shorter review times for their new‐drug applications than more diversified and less R&D‐intensive firms. The reason is that most firm characteristics signal information to reviewers about either firm reputation or application quality. This information reduces reviewers' uncertainty about approving a dangerous or ineffective drug and leads to faster review times. The results suggest that regulators respond to the heterogeneities among firms in the pharmaceutical market in systematic ways.

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  • Mary K. Olson, 1997. "Firm Characteristics and the Speed of FDA Approval," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 6(1), pages 377-401, June.
    • Handle: RePEc:bla:jemstr:v:6:y:1997:i:1:p:377-401
    DOI: 10.1111/j.1430-9134.1997.00377.x
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    Cited by:

    1. Olson, Mary K., 2008. "The risk we bear: The effects of review speed and industry user fees on new drug safety," Journal of Health Economics, Elsevier, vol. 27(2), pages 175-200, March.
    2. Rebecca L. Perlman, 2020. "For Safety or Profit? How Science Serves the Strategic Interests of Private Actors," American Journal of Political Science, John Wiley & Sons, vol. 64(2), pages 293-308, April.
    3. Philipson, Tomas & Berndt, Ernst R. & Gottschalk, Adrian H.B. & Sun, Eric, 2008. "Cost-benefit analysis of the FDA: The case of the prescription drug user fee acts," Journal of Public Economics, Elsevier, vol. 92(5-6), pages 1306-1325, June.
    4. Fiona M. Scott Morton, 2002. "Horizontal Integration Between Brand and Generic Firms in the Pharmaceutical Industry," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 11(1), pages 135-168, March.
    5. Aka, Joël, 2017. "Market approval of phytosanitary active substances in Europe: An empirical duration analysis," Food Policy, Elsevier, vol. 68(C), pages 143-153.
    6. Rogers, Parker, 2022. "Regulating the Innovators: Approval Costs and Innovation in Medical Technologies," SocArXiv c8s3m, Center for Open Science.
    7. Mary K. Olson, 2000. "Regulatory Reform and Bureaucratic Responsiveness to Firms: the Impact of User Fees in the FDA," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 9(3), pages 363-395, June.
    8. Chok, Jay Inghwee, 2009. "Regulatory dependence and Scientific Advisory Boards," Research Policy, Elsevier, vol. 38(5), pages 710-725, June.
    9. Teratanavat, Ratapol P. & Hooker, Neal H. & Salin, Victoria, 2003. "Exploring Meat And Poultry Recall Data For Policy Lessons," 2003 Annual meeting, July 27-30, Montreal, Canada 22142, American Agricultural Economics Association (New Name 2008: Agricultural and Applied Economics Association).
    10. Ilke Onur & Magnus Söderberg, 2020. "The impact of regulatory review time on incremental and radical innovation: evidence from the high-risk medical device market," Journal of Regulatory Economics, Springer, vol. 57(2), pages 134-158, April.
    11. Boakye, Derrick & Sarpong, David & Mordi, Chima, 2022. "Regulatory review of new product innovation: Conceptual clarity and future research directions," Technological Forecasting and Social Change, Elsevier, vol. 175(C).
    12. Mary Olson, 2013. "Eliminating the U.S. drug lag: Implications for drug safety," Journal of Risk and Uncertainty, Springer, vol. 47(1), pages 1-30, August.
    13. DeLong, Gayle, 2018. "Can ‘delitigation’ transform an industry?," The Quarterly Review of Economics and Finance, Elsevier, vol. 67(C), pages 245-254.
    14. Decker, Christopher S, 2003. "Corporate Environmentalism and Environmental Statutory Permitting," Journal of Law and Economics, University of Chicago Press, vol. 46(1), pages 103-129, April.
    15. Hooker, Neal H. & Teratanavat, Ratapol P. & Salin, Victoria, 2005. "Crisis management effectiveness indicators for US meat and poultry recalls," Food Policy, Elsevier, vol. 30(1), pages 63-80, February.
    16. Christopher S. Decker, 2006. "Implementing Environmental Regulation: An Inter-industry Analysis," Eastern Economic Journal, Eastern Economic Association, vol. 32(1), pages 47-66, Winter.

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