IDEAS home Printed from https://ideas.repec.org/a/bla/jemstr/v9y2000i3p363-395.html
   My bibliography  Save this article

Regulatory Reform and Bureaucratic Responsiveness to Firms: the Impact of User Fees in the FDA

Author

Listed:
  • Mary K. Olson

Abstract

This paper examines the impact of user fees on the speed of new‐drug review and on the responsiveness of FDA reviewers to pharmaceutical firms. User fees are expected to alter FDA behavior and responsiveness to pharmaceutical firms because they give regulators a financial incentive to process more new‐drug applications and because they convey information to regulators that may reduce type I error. The analysis examines the variation in FDA review times for new drugs approved between 1990 and 1995 as a function of differences that exist among firms and drugs. Specifically, it compares estimates of regulator responsiveness to several firm and drug characteristics before and after the introduction of user fees. The results show that user fees produced a significant change in FDA behavior. Regulators have become less responsive to the differences among firms since the introduction of user fees, which suggests that the reform has led to more equity in the new‐drug review process. In addition, the FDA has expedited the review of new drugs, especially the most therapeutically novel drugs, which suggests that politicians have been fairly successful in designing a reform to realign regulatory incentives in the FDA.

Suggested Citation

  • 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.
    • Handle: RePEc:bla:jemstr:v:9:y:2000:i:3:p:363-395
    DOI: 10.1111/j.1430-9134.2000.00363.x
    as

    Download full text from publisher

    File URL: https://doi.org/10.1111/j.1430-9134.2000.00363.x
    Download Restriction: no
    File URL: https://libkey.io/10.1111/j.1430-9134.2000.00363.x?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    1. Rebecca Henderson & Iain Cockburn, 1996. "Scale, Scope, and Spillovers: The Determinants of Research Productivity in Drug Discovery," RAND Journal of Economics, The RAND Corporation, vol. 27(1), pages 32-59, Spring.
    2. Olson, Mary, 1996. "Substitution in Regulatory Agencies: FDA Enforcement Alternatives," The Journal of Law, Economics, and Organization, Oxford University Press, vol. 12(2), pages 376-407, October.
    3. DiMasi, Joseph A. & Hansen, Ronald W. & Grabowski, Henry G. & Lasagna, Louis, 1991. "Cost of innovation in the pharmaceutical industry," Journal of Health Economics, Elsevier, vol. 10(2), pages 107-142, July.
    4. Moe, Terry M., 1985. "Control and Feedback in Economic Regulation: The Case of the NLRB," American Political Science Review, Cambridge University Press, vol. 79(4), pages 1094-1116, December.
    5. Joskow, Paul L, 1974. "Inflation and Environmental Concern: Structural Change in the Process of Public Utility Price Regulation," Journal of Law and Economics, University of Chicago Press, vol. 17(2), pages 291-327, October.
    6. Baron, David P. & Besanko, David, 1984. "Regulation and information in a continuing relationship," Information Economics and Policy, Elsevier, vol. 1(3), pages 267-302.
    7. Olson, Mary K, 1995. "Regulatory Agency Discretion among Competing Industries: Inside the FDA," The Journal of Law, Economics, and Organization, Oxford University Press, vol. 11(2), pages 379-405, October.
    8. McCubbins, Mathew D & Noll, Roger G & Weingast, Barry R, 1987. "Administrative Procedures as Instruments of Political Control," The Journal of Law, Economics, and Organization, Oxford University Press, vol. 3(2), pages 243-277, Fall.
    9. Weingast, Barry R & Moran, Mark J, 1983. "Bureaucratic Discretion or Congressional Control? Regulatory Policymaking by the Federal Trade Commission," Journal of Political Economy, University of Chicago Press, vol. 91(5), pages 765-800, October.
    10. Peltzman, Sam, 1976. "Toward a More General Theory of Regulation," Journal of Law and Economics, University of Chicago Press, vol. 19(2), pages 211-240, August.
    11. 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.
    12. David Dranove & David Meltzer, 1994. "Do Important Drugs Reach the Market Sooner?," RAND Journal of Economics, The RAND Corporation, vol. 25(3), pages 402-423, Autumn.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Mary K. Olson, 2002. "Pharmaceutical Policy Change and the Safety of New Drugs," Journal of Law and Economics, University of Chicago Press, vol. 45(S2), pages 615-642.
    2. 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).
    3. Patricia M. Danzon & Eric L. Keuffel, 2014. "Regulation of the Pharmaceutical-Biotechnology Industry," NBER Chapters, in: Economic Regulation and Its Reform: What Have We Learned?, pages 407-484, National Bureau of Economic Research, Inc.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. 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.
    2. Olson, Mary K, 1999. "Agency Rulemaking, Political Influences, Regulation, and Industry Compliance," The Journal of Law, Economics, and Organization, Oxford University Press, vol. 15(3), pages 573-601, October.
    3. Patricia M. Danzon & Eric L. Keuffel, 2014. "Regulation of the Pharmaceutical-Biotechnology Industry," NBER Chapters, in: Economic Regulation and Its Reform: What Have We Learned?, pages 407-484, National Bureau of Economic Research, Inc.
    4. Thompson, Anne M., 2022. "Political connections and the SEC confidential treatment process," Journal of Accounting and Economics, Elsevier, vol. 74(1).
    5. Moser, Peter, 1999. "The impact of legislative institutions on public policy: a survey," European Journal of Political Economy, Elsevier, vol. 15(1), pages 1-33, March.
    6. Kwang-Ho Sim, 2000. "Interests and Political Institutions in U.S. Long-Distance Telecommunications Policy," International Review of Public Administration, Taylor & Francis Journals, vol. 5(1), pages 107-123, June.
    7. Lea Kosnik, 2010. "Balancing Environmental Protection and Energy Production in the Federal Hydropower Licensing Process," Land Economics, University of Wisconsin Press, vol. 86(3).
    8. 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).
    9. Fiona Scott Morton, 1997. "The Objectives of the FDA's Office of Generic Drugs," NBER Working Papers 6143, National Bureau of Economic Research, Inc.
    10. Ando, Amy, 1998. "Delay on the Path to the Endangered Species List: Do Costs and Benefits Matter," RFF Working Paper Series dp-97-43-rev, Resources for the Future.
    11. Danzon, Patricia M. & Nicholson, Sean & Pereira, Nuno Sousa, 2005. "Productivity in pharmaceutical-biotechnology R&D: the role of experience and alliances," Journal of Health Economics, Elsevier, vol. 24(2), pages 317-339, March.
    12. Jodi L. Short, 2021. "The politics of regulatory enforcement and compliance: Theorizing and operationalizing political influences," Regulation & Governance, John Wiley & Sons, vol. 15(3), pages 653-685, July.
    13. Andrew B. Whitford, 2007. "Competing Explanations for Bureaucratic Preferences," Journal of Theoretical Politics, , vol. 19(3), pages 219-247, July.
    14. Rui J. P. De Figueiredo & Geoff Edwards, 2007. "Does Private Money Buy Public Policy? Campaign Contributions and Regulatory Outcomes in Telecommunications," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 16(3), pages 547-576, September.
    15. Tannista Banerjee & Ralph Siebert, 2013. "The Impact of R&D Cooperation on Drug Variety Offered on the Market: Evidence from the Pharmaceutical Industry," Auburn Economics Working Paper Series auwp2013-20, Department of Economics, Auburn University.
    16. Ellig, Jerry, 2016. "Evaluating the Quality and Use of Regulatory Impact Analysis: The Mercatus Center’s Regulatory Report Card, 2008–2013," Working Papers 06878, George Mason University, Mercatus Center.
    17. Min-Seok Pang, 2017. "Politics and Information Technology Investments in the U.S. Federal Government in 2003–2016," Information Systems Research, INFORMS, vol. 28(1), pages 33-45, March.
    18. Mary K. Olson & Nina Yin, 2018. "Examining Firm Responses to R&D Policy: An Analysis of Pediatric Exclusivity," American Journal of Health Economics, MIT Press, vol. 4(3), pages 321-357, Summer.
    19. Mariano Tommasi & Pablo T. Spiller, 2004. "The Institutions of Regulation," Working Papers 67, Universidad de San Andres, Departamento de Economia, revised Mar 2004.
    20. Fremeth, Adam R. & Holburn, Guy L. F. & Piazza, Alessandro, 2021. "Activist Protest Spillovers into the Regulatory Domain: Theory and Evidence from the U.S. Nuclear Power Generation Industry," OSF Preprints s39h2, Center for Open Science.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:bla:jemstr:v:9:y:2000:i:3:p:363-395. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Wiley Content Delivery (email available below). General contact details of provider: http://www.kellogg.northwestern.edu/research/journals/JEMS/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.