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Peltzman Revisited: Quantifying 21st Century Opportunity Costs of FDA Regulation

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  • Casey B. Mulligan

Abstract

This paper revisits Peltzman (1973) in light of two recent opportunities to quantitatively assess tradeoffs in drug regulation. First, reduced regulatory barriers to drug manufacturing associated with the 2017 reauthorization of Generic Drug User Fee Amendments were followed by significantly more entry and lower consumer prices for prescription drugs. Using a simple and versatile industry model and historical data on entry, I find that easing generic restrictions discourages innovation, but this welfare cost is more than offset by consumer benefits from enhanced competition, especially after 2016. Second, accelerated vaccine approval in 2020 had unprecedented net benefits as it not only improved health but substantially changed the trajectory of the wider economy. The evidence suggests that cost-benefit analysis of FDA regulation is incomplete without accounting for substitution toward potentially unsafe and ineffective treatments that are both outside FDA jurisdiction and heavily utilized prior to FDA approval. Moreover, the policy processes initiating these 21st century regulatory changes show a clear influence of Peltzman’s 1973 findings.

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  • Casey B. Mulligan, 2021. "Peltzman Revisited: Quantifying 21st Century Opportunity Costs of FDA Regulation," NBER Working Papers 29574, National Bureau of Economic Research, Inc.
  • Handle: RePEc:nbr:nberwo:29574
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    1. Thomas J. Kniesner, 2019. "Behavioral economics and the value of a statistical life," Journal of Risk and Uncertainty, Springer, vol. 58(2), pages 207-217, June.
    2. Isakov, Leah & Lo, Andrew W. & Montazerhodjat, Vahid, 2019. "Is the FDA too conservative or too aggressive?: A Bayesian decision analysis of clinical trial design," Journal of Econometrics, Elsevier, vol. 211(1), pages 117-136.
    3. Philipson Tomas J & Jena Anupam B, 2006. "Who Benefits from New Medical Technologies? Estimates of Consumer and Producer Surpluses for HIV/AIDS Drugs," Forum for Health Economics & Policy, De Gruyter, vol. 9(2), pages 1-33, January.
    4. Casey B. Mulligan, 2020. "Prices and Federal Policies in Opioid Markets," Working Papers 2020-10, Becker Friedman Institute for Research In Economics.
    5. Michael Kremer, 2001. "Creating Markets for New Vaccines - Part II: Design Issues," NBER Chapters, in: Innovation Policy and the Economy, Volume 1, pages 73-118, National Bureau of Economic Research, Inc.
    6. Casey B. Mulligan, 2021. "The Backward Art of Slowing the Spread? Congregation Efficiencies during COVID-19," NBER Working Papers 28737, National Bureau of Economic Research, Inc.
    7. Anna Anderson-Cook & Jared Maeda & Lyle Nelson, 2019. "Prices for and Spending on Specialty Drugs in Medicare Part D and Medicaid: An In-Depth Analysis: Working Paper 2019-02," Working Papers 55011, Congressional Budget Office.
    8. Geoffard, Pierre-Yves & Philipson, Tomas, 1997. "Disease Eradication: Private versus Public Vaccination," American Economic Review, American Economic Association, vol. 87(1), pages 222-230, March.
    9. Casey B. Mulligan, 2021. "The Incidence and Magnitude of the Health Costs of In-person Schooling during the COVID-19 Pandemic," NBER Working Papers 28619, National Bureau of Economic Research, Inc.
    10. Casey B. Mulligan, 2021. "The incidence and magnitude of the health costs of in-person schooling during the COVID-19 pandemic," Public Choice, Springer, vol. 188(3), pages 303-332, September.
    11. William D. Nordhaus, 2004. "Schumpeterian Profits in the American Economy: Theory and Measurement," NBER Working Papers 10433, National Bureau of Economic Research, Inc.
    12. 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.
    13. Gary S. Becker & Tomas J. Philipson & Rodrigo R. Soares, 2005. "The Quantity and Quality of Life and the Evolution of World Inequality," American Economic Review, American Economic Association, vol. 95(1), pages 277-291, March.
    14. 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.
    15. William N. Evans & Ethan M. J. Lieber & Patrick Power, 2019. "How the Reformulation of OxyContin Ignited the Heroin Epidemic," The Review of Economics and Statistics, MIT Press, vol. 101(1), pages 1-15, March.
    16. Bardt, Hubertus & Hüther, Michael & Klös, Hans-Peter, 2021. "Modernisierung durch Investition," IW-Reports 22/2021, Institut der deutschen Wirtschaft (IW) / German Economic Institute.
    17. Michael Kremer, 2001. "Creating Markets for New Vaccines - Part I: Rationale," NBER Chapters, in: Innovation Policy and the Economy, Volume 1, pages 35-72, National Bureau of Economic Research, Inc.
    18. Tomas Philipson, 1996. "Private Vaccination and Public Health: An Empirical Examination for U.S. Measles," Journal of Human Resources, University of Wisconsin Press, vol. 31(3), pages 611-630.
    19. Mukherjee, Arijit, 2005. "Price and quantity competition under free entry," Research in Economics, Elsevier, vol. 59(4), pages 335-344, December.
    20. Darius Lakdawalla & Tomas Philipson, 2012. "Does Intellectual Property Restrict Output? An Analysis of Pharmaceutical Markets," Journal of Law and Economics, University of Chicago Press, vol. 55(1), pages 151-187.
    21. Philipson, Tomas, 1995. "The welfare loss of disease and the theory of taxation," Journal of Health Economics, Elsevier, vol. 14(3), pages 387-395, August.
    22. Ernst R. Berndt & Rachel Glennerster & Michael R. Kremer & Jean Lee & Ruth Levine & Georg Weizsäcker & Heidi Williams, 2007. "Advance market commitments for vaccines against neglected diseases: estimating costs and effectiveness," Health Economics, John Wiley & Sons, Ltd., vol. 16(5), pages 491-511, May.
    23. Bernard Barraqué, 2012. "WFD Implementation in France: integrated or complex ?," Post-Print hal-00797309, HAL.
    24. Liam Brunt & Cecilia García-Peñalosa, 2022. "Urbanisation and the Onset of Modern Economic Growth," The Economic Journal, Royal Economic Society, vol. 132(642), pages 512-545.
    25. Frank R. Lichtenberg & Tomas J. Philipson, 2002. "The Dual Effects of Intellectual Property Regulations: Within- and Between-Patent Competition in the U.S. Pharmaceuticals Industry," Journal of Law and Economics, University of Chicago Press, vol. 45(S2), pages 643-672.
    26. Casey B. Mulligan, 2020. "Prices and Federal Policies in Opioid Markets," NBER Working Papers 26812, National Bureau of Economic Research, Inc.
    27. Abby Alpert & David Powell & Rosalie Liccardo Pacula, 2018. "Supply-Side Drug Policy in the Presence of Substitutes: Evidence from the Introduction of Abuse-Deterrent Opioids," American Economic Journal: Economic Policy, American Economic Association, vol. 10(4), pages 1-35, November.
    28. Boldrin,Michele & Levine,David K., 2010. "Against Intellectual Monopoly," Cambridge Books, Cambridge University Press, number 9780521127264, November.
    29. 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.
    30. Kenneth Arrow, 1962. "Economic Welfare and the Allocation of Resources for Invention," NBER Chapters, in: The Rate and Direction of Inventive Activity: Economic and Social Factors, pages 609-626, National Bureau of Economic Research, Inc.
    31. Geoffard, Pierre-Yves & Philipson, Tomas, 1996. "Rational Epidemics and Their Public Control," International Economic Review, Department of Economics, University of Pennsylvania and Osaka University Institute of Social and Economic Research Association, vol. 37(3), pages 603-624, August.
    32. James W. Hughes & Michael J. Moore & Edward A. Snyder, 2002. ""Napsterizing" Pharmaceuticals: Access, Innovation, and Consumer Welfare," NBER Working Papers 9229, National Bureau of Economic Research, Inc.
    33. ., 2021. "Rise of the modern electric vehicle," Chapters, in: The Global Rise of the Modern Plug-In Electric Vehicle, chapter 1, pages 1-33, Edward Elgar Publishing.
    34. 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.
    35. Anders Bergström & Chris Stringer & Mateja Hajdinjak & Eleanor M. L. Scerri & Pontus Skoglund, 2021. "Origins of modern human ancestry," Nature, Nature, vol. 590(7845), pages 229-237, February.
    36. N. Gregory Mankiw & Michael D. Whinston, 1986. "Free Entry and Social Inefficiency," RAND Journal of Economics, The RAND Corporation, vol. 17(1), pages 48-58, Spring.
    37. Temin, Peter, 1992. "Realized Benefits from Switching Drugs," Journal of Law and Economics, University of Chicago Press, vol. 35(2), pages 351-369, October.
    38. Vernon, John A. & Golec, Joseph H. & Lutter, Randall & Nardinelli, Clark, 2009. "An exploratory study of FDA new drug review times, prescription drug user fee acts, and R&D spending," The Quarterly Review of Economics and Finance, Elsevier, vol. 49(4), pages 1260-1274, November.
    39. Rodrigo Cerda, 2003. "Drugs, Market Size and Population," Documentos de Trabajo 238, Instituto de Economia. Pontificia Universidad Católica de Chile..
    40. Ruhm, Christopher J., 2019. "Drivers of the fatal drug epidemic," Journal of Health Economics, Elsevier, vol. 64(C), pages 25-42.
    41. Mulligan, Casey B., 2021. "Economic Activity and the Value of Medical Innovation during a Pandemic," Journal of Benefit-Cost Analysis, Cambridge University Press, vol. 12(3), pages 420-440, October.
    42. Clare Halloran & Rebecca Jack & James C. Okun & Emily Oster, 2021. "Pandemic Schooling Mode and Student Test Scores: Evidence from US States," NBER Working Papers 29497, National Bureau of Economic Research, Inc.
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    More about this item

    JEL classification:

    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health
    • L51 - Industrial Organization - - Regulation and Industrial Policy - - - Economics of Regulation
    • L65 - Industrial Organization - - Industry Studies: Manufacturing - - - Chemicals; Rubber; Drugs; Biotechnology; Plastics
    • O31 - Economic Development, Innovation, Technological Change, and Growth - - Innovation; Research and Development; Technological Change; Intellectual Property Rights - - - Innovation and Invention: Processes and Incentives

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