IDEAS home Printed from https://ideas.repec.org/a/ucp/jlawec/doi10.1086-368006.html
   My bibliography  Save this article

Pharmaceutical Policy Change and the Safety of New Drugs

Author

Listed:
  • Mary K. Olson

Abstract

Policy reforms in the Food and Drug Administration (FDA) have led to substantial increases in the speed of new-drug review. While data show that FDA review times for new drugs have fallen as much as 50 percent, other data show that several new drugs have been withdrawn from the market for safety reasons. This flurry of new-drug withdrawals raises a question. Have increases in the speed of new-drug review had an adverse effect on new-drug safety? This analysis uses adverse drug reaction (ADR) data from the FDA’s Spontaneous Reporting System to examine this question. Specifically, ADR counts for newly approved drugs are estimated as a function of drug characteristics, patient characteristics, and regulatory factors (such as the speed of new-drug review) using negative binomial regression analysis. The primary result is that reductions in new-drug review times are associated with increases in both ADRs requiring hospitalization and ADRs resulting in death.

Suggested Citation

  • 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.
  • Handle: RePEc:ucp:jlawec:doi:10.1086/368006
    DOI: 10.1086/368006
    as

    Download full text from publisher

    File URL: http://dx.doi.org/10.1086/368006
    Download Restriction: Access to the online full text or PDF requires a subscription.

    File URL: http://dx.doi.org/10.1086/368006
    Download Restriction: Access to the online full text or PDF requires a subscription.

    File URL: https://libkey.io/10.1086/368006?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. 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.
    2. 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.
    3. Peltzman, Sam, 1987. "The Health Effects of Mandatory Prescriptions," Journal of Law and Economics, University of Chicago Press, vol. 30(2), pages 207-238, October.
    4. 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.
    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. 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. Andreas Schick & Kathleen L. Miller & Michael Lanthier & Gerald Dal Pan & Clark Nardinelli, 2017. "Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals," Drug Safety, Springer, vol. 40(6), pages 497-503, June.
    3. Allan Begosh & John Goldsmith & Ed Hass & Randall W. Lutter & Clark Nardinelli & John A. Vernon, 2006. "Black Box Warnings and Drug Safety: Examining the Determinants and Timing of FDA Warning Labels," NBER Working Papers 12803, National Bureau of Economic Research, Inc.
    4. 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.
    5. 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.
    6. 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.
    7. Light, Donald W. & Lexchin, Joel R., 2021. "Pharmaceuticals as a market for “lemons”: Theory and practice," Social Science & Medicine, Elsevier, vol. 268(C).
    8. 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.
    9. 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.
    10. 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.
    11. Abraham, John & Davis, Courtney, 2005. "A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): Implications for current regulatory thinking and policy," Social Science & Medicine, Elsevier, vol. 61(5), pages 881-892, September.
    12. W. David Bradford & Andrew N. Kleit, 2015. "Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication," Health Economics, John Wiley & Sons, Ltd., vol. 24(7), pages 859-875, July.
    13. Olson, Mary K., 2004. "Are novel drugs more risky for patients than less novel drugs?," Journal of Health Economics, Elsevier, vol. 23(6), pages 1135-1158, November.

    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. 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.
    2. 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.
    3. 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).
    4. Marc T. Law & Zeynep K. Hansen, 2009. "Medical Licensing Board Characteristics and Physician Discipline: An Empirical Analysis," NBER Working Papers 15140, National Bureau of Economic Research, Inc.
    5. 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.
    6. 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.
    7. 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.
    8. Helland, Eric, 1998. "The Revealed Preferences of State EPAs: Stringency, Enforcement, and Substitution," Journal of Environmental Economics and Management, Elsevier, vol. 35(3), pages 242-261, May.
    9. 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.
    10. 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.
    11. Soonae Park & Don S. Lee & Jieun Son, 2021. "Regulatory reform in the era of new technological development: The role of organizational factors in the public sector," Regulation & Governance, John Wiley & Sons, vol. 15(3), pages 894-908, July.
    12. Russell Smyth & Magnus Söderberg, 2010. "Public interest versus regulatory capture in the Swedish electricity market," Journal of Regulatory Economics, Springer, vol. 38(3), pages 292-312, December.
    13. Lea Kosnik, 2010. "Balancing Environmental Protection and Energy Production in the Federal Hydropower Licensing Process," Land Economics, University of Wisconsin Press, vol. 86(3).
    14. Gary W. Cox, 1999. "The Empirical Content of Rational Choice Theory," Journal of Theoretical Politics, , vol. 11(2), pages 147-169, April.
    15. Mark Duggan & Fiona M. Scott Morton, 2006. "The Distortionary Effects of Government Procurement: Evidence from Medicaid Prescription Drug Purchasing," The Quarterly Journal of Economics, President and Fellows of Harvard College, vol. 121(1), pages 1-30.
    16. Stern, Ariel Dora, 2017. "Innovation under regulatory uncertainty: Evidence from medical technology," Journal of Public Economics, Elsevier, vol. 145(C), pages 181-200.
    17. Wayne Eastman & Deirdre Collier, 2012. "The Optimal Bargain between the Elite and the Majority: Party and Managerial Ideologies as Devices to Control Politicians and Managers," Group Decision and Negotiation, Springer, vol. 21(4), pages 475-494, July.
    18. Bowman Cutter, W. & DeShazo, J.R., 2007. "The environmental consequences of decentralizing the decision to decentralize," Journal of Environmental Economics and Management, Elsevier, vol. 53(1), pages 32-53, January.
    19. Walter E. Block, 2017. "Radical Privatization: Oceans, Roads,Heavenly Bodies," Romanian Economic Business Review, Romanian-American University, vol. 12(2), pages 41-56, June.
    20. Olson, Mary K., 2004. "Are novel drugs more risky for patients than less novel drugs?," Journal of Health Economics, Elsevier, vol. 23(6), pages 1135-1158, November.

    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:doi:10.1086/368006. 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.