IDEAS home Printed from https://ideas.repec.org/a/ucp/jlawec/v51y2008i2p377-406.html
   My bibliography  Save this article

Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act

Author

Listed:
  • Henry Grabowski
  • Y. Richard Wang

Abstract

Food and Drug Administration (FDA) review times have significantly declined under the user-fee regime. This situation has provoked concerns that drug safety has been adversely affected. Combining information from several comprehensive databases, we analyze how the FDA's review time, a drug's novelty, and a lag between the foreign and U.S. launches of a drug affect the number of serious adverse events associated with new-drug introductions in the United States in 1992-2002. We find that more novel drugs, those with shorter U.S. launch lags, and those with black-box warnings have a larger number of serious adverse events. After controlling for these and other factors, we find no association between the FDA's review time and adverse events. Because many serious adverse events involve rare occurrences that are not observable in premarket clinical trials, policy makers should direct increased agency attention and resources to postmarketing surveillance. (c) 2008 by The University of Chicago. All rights reserved.

Suggested Citation

  • Henry Grabowski & Y. Richard Wang, 2008. "Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act," Journal of Law and Economics, University of Chicago Press, vol. 51(2), pages 377-406, May.
    • Handle: RePEc:ucp:jlawec:v:51:y:2008:i:2:p:377-406
    DOI: 10.1086/589934
    as

    Download full text from publisher

    File URL: http://dx.doi.org/10.1086/589934
    File Function: link to full text
    Download Restriction: Access to full text is restricted to subscribers.
    File URL: https://libkey.io/10.1086/589934?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
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Niklas Rudholm, 2004. "Approval times and the safety of new pharmaceuticals," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 5(4), pages 345-350, November.
    2. 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.
    3. 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.
    4. Peltzman, Sam, 1973. "An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments," Journal of Political Economy, University of Chicago Press, vol. 81(5), pages 1049-1091, Sept.-Oct.
    5. Iain M. Cockburn, 2007. "Is the Pharmaceutical Industry in a Productivity Crisis?," NBER Chapters, in: Innovation Policy and the Economy, Volume 7, pages 1-32, National Bureau of Economic Research, Inc.
    6. Grabowski, Henry G & Vernon, John M & Thomas, Lacy Glenn, 1978. "Estimating the Effects of Regulation on Innovation: An International Comparative Analysis of the Pharmaceutical Industry," Journal of Law and Economics, University of Chicago Press, vol. 21(1), pages 133-163, April.
    7. DiMasi, Joseph A. & Hansen, Ronald W. & Grabowski, Henry G., 2003. "The price of innovation: new estimates of drug development costs," Journal of Health Economics, Elsevier, vol. 22(2), pages 151-185, March.
    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 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.
    2. Matthew Grennan & Robert J. Town, 2020. "Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices," American Economic Review, American Economic Association, vol. 110(1), pages 120-161, January.
    3. Raymond J. March, 2021. "The FDA and the COVID‐19: A political economy perspective," Southern Economic Journal, John Wiley & Sons, vol. 87(4), pages 1210-1228, April.
    4. Anna Chorniy & James Bailey & Abdulkadir Civan & Michael Maloney, 2021. "Regulatory review time and pharmaceutical research and development," Health Economics, John Wiley & Sons, Ltd., vol. 30(1), pages 113-128, January.
    5. 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).

    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. Chorniy, Anna & Bailey, James & Maloney, Michael & Civan, Abdulkadir, 2019. "Regulatory Review Time and Pharmaceutical R&D," Working Papers 06923, George Mason University, Mercatus Center.
    2. 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.
    3. Raymond J. March, 2021. "The FDA and the COVID‐19: A political economy perspective," Southern Economic Journal, John Wiley & Sons, vol. 87(4), pages 1210-1228, April.
    4. Anna Chorniy & James Bailey & Abdulkadir Civan & Michael Maloney, 2021. "Regulatory review time and pharmaceutical research and development," Health Economics, John Wiley & Sons, Ltd., vol. 30(1), pages 113-128, January.
    5. Tomas J. Philipson & Eric Sun, 2008. "Is the Food And Drug Administration Safe And Effective?," Journal of Economic Perspectives, American Economic Association, vol. 22(1), pages 85-102, Winter.
    6. 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.
    7. Simone Ghislandi & Michael Kuhn, 2016. "Asymmetric information in the regulation of the access to markets," Department of Economics Working Papers wuwp219, Vienna University of Economics and Business, Department of Economics.
    8. 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.
    9. Lorenz, Steffi, 2015. "Diversität und Verbundenheit der unternehmerischen Wissensbasis: Ein neuartiger Messansatz mit Indikatoren aus Innovationsprojekten," Discussion Papers on Strategy and Innovation 15-01, Philipps-University Marburg, Department of Technology and Innovation Management (TIM).
    10. Scherer, F.M., 2010. "Pharmaceutical Innovation," Handbook of the Economics of Innovation, in: Bronwyn H. Hall & Nathan Rosenberg (ed.), Handbook of the Economics of Innovation, edition 1, volume 1, chapter 0, pages 539-574, Elsevier.
    11. Philipson Tomas J. & Sun Eric & Goldman Dana & Jena Anupam B., 2012. "A Reexamination of the Costs of Medical R&D Regulation," Forum for Health Economics & Policy, De Gruyter, vol. 15(2), pages 1-28, October.
    12. 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.
    13. Ernst R. Berndt & Joseph P. Newhouse, 2010. "Pricing and Reimbursement in U.S. Pharmaceutical Markets," NBER Working Papers 16297, National Bureau of Economic Research, Inc.
    14. Matthew Grennan & Robert J. Town, 2020. "Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices," American Economic Review, American Economic Association, vol. 110(1), pages 120-161, January.
    15. Ollinger, Michael & Fernandez-Cornejo, Jorge, 1998. "Innovation and Regulation in the Pesticide Industry," Agricultural and Resource Economics Review, Cambridge University Press, vol. 27(1), pages 15-27, April.
    16. Tomas J. Philipson & George Zanjani, 2013. "Economic Analysis of Risk and Uncertainty induced by Health Shocks: A Review and Extension," NBER Working Papers 19005, National Bureau of Economic Research, Inc.
    17. Guy David & Sara Markowitz & Seth Richards-Shubik, 2010. "The Effects of Pharmaceutical Marketing and Promotion on Adverse Drug Events and Regulation," American Economic Journal: Economic Policy, American Economic Association, vol. 2(4), pages 1-25, November.
    18. Abbott, Thomas III, 1995. "Price regulation in the pharmaceutical industry: Prescription or placebo?," Journal of Health Economics, Elsevier, vol. 14(5), pages 551-565, December.
    19. Ollinger, Michael & Fernandez-Cornejo, Jorge, 1995. "Regulation, Innovation, and Market Structure in the U.S. Pesticide Industry," Agricultural Economic Reports 308425, United States Department of Agriculture, Economic Research Service.
    20. 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).

    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:ucp:jlawec:v:51:y:2008:i:2:p:377-406. 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: Journals Division (email available below). General contact details of provider: https://www.journals.uchicago.edu/JLE .

    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.