Hostname: page-component-586b7cd67f-vdxz6 Total loading time: 0 Render date: 2024-11-25T07:35:55.008Z Has data issue: false hasContentIssue false

Skin in the game: comparing the private and public regulation of isotretinoin

Published online by Cambridge University Press:  01 December 2016

RAYMOND J. MARCH*
Affiliation:
Department of Agricultural and Applied Economics Office 203-C, Texas Tech University, Lubbock, TX 79409 (806) 834–7217, USA

Abstract

This paper engages in a comparative-institutional analysis of the private and public risk-management programs of the drug isotretinoin, which are designed to prevent the undesired effects isotretinoin has on fetal development. This case study sheds light on the comparative effectiveness of private and public regulation in the pharmaceutical and healthcare markets. A range of evidence indicates that the private risk management program successful in reducing pregnancies and educating patients about the harmful effects isotretinoin can have on a fetus. These findings challenge a consensus found in the medical literature that the private program needed to be supplanted and contain implications for future risk-management policy in healthcare.

Type
Research Article
Copyright
Copyright © Millennium Economics Ltd 2016 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Abroms, L., Maibach, E., Lyon-Daniel, K., and Feldman, S. (2006), ‘What is the Best Approach to Reducing Birth Defects Associated with Isotretinoin?’, PLOS Medicine, 3 (11): 19781983.CrossRefGoogle ScholarPubMed
Adams, J. and Lammer, E. (1991), Functional Neuroteratology of Short-Term Exposure to Drugs, Tokyo: Teikyo University Press.Google Scholar
Aguilar, S., Louis, C., Hicks, J., Zage, P., and Russell, H. (2014). ‘Congenital Neuroblastomain Aneonate with Isotretinoin Embryopathy’, Journal of Pediatric Hematology/Oncology, 36 (2): 7577.Google Scholar
American Academy of Dermatology (2015), ‘Isotretinoin: Treatment for Severe Acne’, [online] https://www.aad.org/public/diseases/acne-and-rosacea/isotretinoin-treatment-for-severe-acne (accessed April 2016).Google Scholar
Arrow, K. (1963), ‘Uncertainty and the Welfare Economics of Medical Care’, American Economic Review, 53 (5): 941972.Google Scholar
Bloom, G., Standing, H., and Lloyd, R. (2008), ‘Markets, Information Asymmetry and Health Care: Toward New Social Contracts’, Social Science Medicine, 66 (10): 20762087.Google Scholar
Boettke, P. J. (2012), Living Economics Yesterday, Today, and Tomorrow, Oakland, CA: The Independent Institute.Google Scholar
Boettke, P. J. and Coyne, C. J. (2005), ‘Methodological Individualism, Spontaneous Order and the Research Program of the Workshop in Political Theory and Policy Analysis’, Journal of Economic Behavior and Organization, 57 (2): 145158.Google Scholar
Boettke, P. J., Coyne, C. J., and Leeson, P. T. (2013), ‘Comparative Historical Political Economy’, Journal of Institutional Economics, 9 (3): 285301.Google Scholar
Boettke, P. J., Palagashvili, L., and Lemke, J. (2013), ‘Riding in Cars with Boys: Elinor Ostrom's Adventures with the Police’, Journal of Institutional Economics, 9 (4): 407425.Google Scholar
Boodman, S. (2006), Too hard to take. The Washington Post, 2006 September 5. [online] http://www.washingtonpost.com/wp-dyn/content/article/2006/09/03/AR2006090300590.html (accessed July 2015).Google Scholar
Brinker, A., Kornegay, C., and Nourjah, P. (2005), ‘Trends in Adherence to a Revised Risk Management Program Designed to Decrease or Eliminate Isotretinoin-Exposed Pregnancies’, Archives Journal of the American Academy of Dermatology, 141 (5): 563599.Google Scholar
Brinker, A., Trontell, A., and Beitz, A. (2002), ‘Pregnancy and Pregnancy Rates in Association with Isotretinoin (Accutane)’, Journal of the American Academy of Dermatology, 47 (5): 798–779.Google Scholar
Brown, S. and Connelly, L. B. (2005), ‘Market failure in long-term private health insurance markets: a proposed solution’, Applied Economic Letters, 12 (5): 281–284.Google Scholar
Center for Disease Control (2015), ‘2010 Pregnancy Rates Among US Women’, [online] http://www.cdc.gov/nchs/data/hestat/pregnancy/2010_pregnancy_rates.pdf (accessed May 2016).Google Scholar
Demsetz, H. (1969), ‘Information and Efficiency: Another Viewpoint’, Journal of Law and Economics, 12 (1): 122.Google Scholar
Dooren, C. (2006), ‘Accutane IPledge Program Requirements Leading to Illegal Online Sales’, [online] Wall Street Journal, 13 September. (accessed April 2014).Google Scholar
Doshi, A. (2007), ‘The Cost of Clear Skin: Balancing the Social and Safety Costs of IPledge with the Efficacy of Accutane (Isotretinoin)’, Seton Hall Law Review, 37 (2): 625660.Google Scholar
Eggleston, K. (2011), ‘Prescribing Institutions: Explaining the Evolution of Physician Dispensing’, Journal of Institutional Economics, 8 (2): 247270.Google Scholar
Food and Drug Administration (2007), ‘FDA Launches Web Page Warning Against Buying Accutane and its Generic Versions’, [online] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108876.htm. (accessed April 2016).Google Scholar
Food and Drug Administration, n.d.a. Dermatologic and Ophthalmic Drugs Advisory Committee briefing document for NDA18-662 Accutane® (isotretinoin) capsules. [online] http://www.fda.gov/ohrms/dockets/ac/04/briefing/4017b1_roche-Briefing%20Package.pdf. (accessed September 2015).Google Scholar
Food and Drug Administration, n.d.b. Estimating Accutane Use. [online] http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3639b1c_05.pdf (accessed September 2015).Google Scholar
Food and Drug Administration, n.d.d. Isotretinoin update: iPLEDGE. [online] http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4202B1_10_FDA-Tab10.pdf (accessed April 2016).Google Scholar
Food and Drug Administration, n.d.e. Dermatologic and Ophthalmic Drugs Advisory Committee Briefing Document for NDA 18–622 Accutane® (isotretinoin) Capsules http://www.fda.gov/ohrms/dockets/ac/04/briefing/4017b1_roche-Briefing%20Package.pdf. (accessed March 2015).Google Scholar
Food and Drug Administration, n.d.e. Pregnancy Prevention Program: A Risk Management Program to Reduce Pregnancies During Accutane Treatment. [online] http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3639b1c_06.pdf (accessed September 2015).Google Scholar
Forstner, M. Evaluation of the Effectiveness of Risk Management, Roche, Basel, Switzerland: PowerPoint Presentation.Google Scholar
Globerman, S., Hodges, H., and Vining, A. (2002). ‘Canadian and United States’ Health Care Systems Performance and Governance: Elements of Convergence’, Applied Health Economics Health Policy, 1 (2): 7588.Google Scholar
Goldsmith, L. A., Bolognia, J. L., Callen, J. P., Chen, S. C., Feldman, S. R., Lim, H. W., Lucky, A. W., Reed, B. R., Siegfried, E. C., Thiboutot, D. M., and Wheeland, R. G. (2004), ‘American Academy of Dermatology Consensus Conference on the Safe and Optimal Use of Isotretinoin: Summary and Recommendations’, Journal of the American Academy of Dermatology, 50 (60): 900906.Google Scholar
Gray, B. (1986), For-Profit Enterprise in Health Care, Washington, DC: National Academy Press.Google Scholar
Hoffman, J., Coffey, J., and Stubbings, J. (2010), ‘Practical Implementation of Risk Evaluations and Mitigation Strategies in Health Systems: The Experts Answer your Questions’, ASHP Advantage E-Newsletter. [online] http://www.ashpadvantage.com/fdaaa/fdaaa-spring-newsletter.pdf (accessed September 2015).Google Scholar
Honein, M. A., Moore, C. A., and Erickson, J. D. (2004), ‘Can we Ensure the Safe use of known Human Teratogens? Introduction of Generic Isotretinoin in the US as an Example’, Drug Safety, 27 (14): 10691080.Google Scholar
Klein, D. and Tabarrok, A. (2004), ‘Who certifies off-label?’, Regulation, 27 (2): 6063.Google Scholar
Leeson, P. T. (2007), ‘Better off Stateless: Somalia Before and After Government Collapse’, Journal of Comparative Economics, 35 (4): 689710.Google Scholar
Leeson, P. T. (2011), ‘Government, Clubs, and Constitutions’, Journal of Behavior, & Organization, 80 (2): 301308.Google Scholar
Leeson, P. T. (2014a), ‘Pirates, Prisoners, and Preliterates: Anarchic Context and the Private Enforcement of Law’, European Journal of Law and Economics, 37 (3): 365379.Google Scholar
Leeson, P. T. (2014b), Anarchy Unbound why Self-Governance Works Better than you Think, Cambridge, MA: Cambridge University Press.Google Scholar
Leeson, P. T. and Coyne, C. J. (2012), ‘Sassywood’, Journal of Comparative Economics, 40 (4): 608620.Google Scholar
Leeson, P. T. and Boettke, P. J. (2009), ‘Two-Tiered Entrepreneurship and Economic Development’, International Review of Law and Economics, 29 (3): 252259.CrossRefGoogle Scholar
Leibman, M. (2003), ‘Off-label, in Bounds’, Medical Marketing and Media. 1 December, Available. [online] https://www.highbeam.com/doc/1P3-501142641.html (accessed September 2015).Google Scholar
Leiderman, D. (2009), ‘Risk Management of Drug Products and the U.S. Food and Drug Administration: Evolution and Context’, Drug and Alcohol Dependence, 105S (1): S9–S15.Google Scholar
Lipper, G. (2007), ‘Isotretinoin and iPLEDGE: Too Much Regulation or not Enough?’, Medscape Dermatology. 12 January [online] http://www.medscape.com/viewarticle/550255 (accessed October 2015).Google Scholar
Lynk, W. J. (1995), ‘The Creation of Economic Efficiencies in Hospital Mergers’, Journal of Health Economics, 15 (5): 507530.Google Scholar
Main, E. (2009), ‘Prescription Acne Drug Pulled from Shelve’, Rodale News, 13 July. [online] http://www.rodalenews.com/acne-treatment-drug-accutane-pulled-market?page=0 (accessed April 2014).Google Scholar
Maloney, M., and Stone, S. (2011), ‘Isotretinoin and IPledge: A View of Results’, Journal of the American Academy of Dermatology, 65 (2): 418419.CrossRefGoogle ScholarPubMed
McCormick, C. G., Henningfield, J. E., Haddox, J. D., Varguhese, S., Lindholm, A., Rosen, S., Wissel, J., Waxman, D., Carter, L. P., Seeger, V., and Johnson, R. E. (2009), ‘Case Histories in Pharmaceutical Risk Management’, Drug and Alcohol Independence, 105S (1): S42–S55.Google Scholar
Meadows, M. (2001). ‘The Power of Accutane’, FDA Consumer, 35 (2): 1923.Google Scholar
Medscape (2002), ‘Roche Initiates Enhanced Program to Prevent Accutane-Exposed Pregnancies’, Medscape Medical News. 22 February. [online] http://www.medscape.com/viewarticle/428738 (accessed September 2015).Google Scholar
Mendelson, A., Governale, L., Trontell, A., and Seligman, P. (2005), ‘Changes in Isotretinoin Prescribing before and After Implementation of the System to Manage Accutane Related Teratogenicity (SMART) Risk Management Program’, Pharmacoepidemiology and Drug Safety, 14 (9): 615618.Google Scholar
Miller, H. (1998), ‘Failed FDA Reform’, Regulation, 21 (3): 2330.Google Scholar
Milne, R. and Torsney, B. (1997), ‘The Efficiency of Administrative Governance: The Experience of Pre-Reform British National Health Service’, Journal of Comparative Economics, 24 (2): 161180.Google Scholar
Mises, L. (1944), Bureaucracy, New Haven, CT: Yale University Press.Google Scholar
Mitchell, A., Van Bennekom, C., and Louik, C. (1995), ‘A Pregnancy Prevention Program in Women of Childbearing Age Receiving Isotretinoin’, New England Journal of Medicine, 333 (2): 101106.Google Scholar
Mobacken, H., Sundström, A., and Vahlquist, A. (2014), ‘30 Years with Isotretinoin “Miracle Medicine” Against Acne with Many Side Effects’, Lakartidningen, 111 (3–4): 9396.Google Scholar
Mosher, W. D. and Jones, J., (2010), ‘Use of Contraception in the United States: 1982–2008. National Center for Health Statistics’, [online] http://www.cdc.gov/nchs/data/series/sr_23/sr23_029.pdf (accessed July 2016).Google Scholar
Mushkin, S. (1958), ‘Toward a Definition of Health Economists’, Public Health Reports, 73 (9): 785793.CrossRefGoogle Scholar
Ostrom, E. (2005), Understanding Institutional Diversity, Princeton, NJ: Princeton University Press.Google Scholar
Ostrom, E. (2010), ‘Beyond Markets and States: Polycentric Governance of Complex Economic Systems’, American Economic Review, 100 (3): 133.Google Scholar
Pathak, D. and Escovitz, A. (1996), ‘Managed Competition and Pharmaceutical Care: An Answer to Market Failure’, Journal of Research In Pharmaceutical Economics, 7 (1–2): 16.Google Scholar
Peltzman, S. (1973), ‘An Evaluation of Consumer Protection Legislation: The 1962 Drug amendments’, Journal of Political Economy, 81 (5): 10491091.Google Scholar
Pinhero, S. P., Kang, E. M., Kim, C. Y., Governale, L. A., Zhou, E. H., and Hammad, T. A. (2013), ‘Concomitant use of Isotretinoin and Contraceptives Before and After iPledge in the United States’, Pharmacoepidemiology Drug Safety, 22 (12): 12511257.Google Scholar
Robertson, J., Polifka, J. E., Avner, M., Chambers, C., Delevan, G., Koren, G., Lavigne, S. V. S. V., Martinez, L. P., Martinez, L. P., Miller, R. K., and Carey, J. C. (2005), ‘A Survey of Pregnant Woman using Isotretinoin’, Birth Defects Research Part A: Clinical and Molecular, 73 (11): 881887.Google Scholar
Ruke, K. (2014), ‘Former FDA Staffer Claims Prescription Drug “Black Market” Going Unreported’, Mint Press News. 5 May. [online] http://www.mintpressnews.com/former-fda-staffer-claims-prescription-drug-black-market-going-unreported/190064/ (accessed May 2015).Google Scholar
Savedoff, W. (2004), ‘Kenneth Arrow and the Birth of Health Economics’, Bulletin of the World Health Organization, 82 (2): 139140.Google Scholar
Schonfeld, T. L., Amoura, N. J., and Kratochvil, C. J., (2009), ‘iPLEDGE Allegiance to the Pill: Evaluation of Year 1 of a Birth Defect Prevention and Monitoring System’, Journal of Law, Medicine, and Ethics, 37 (1): 104117.Google Scholar
Shin, J., Cheetham, T. C., Wong, L., Nui, F., Kass, E., Yoshinaga, M. A., Sorel, M., McCombs, J. S., and Sidney, S. (2011), ‘The Impact of the iPLEDGE Program on Isotretinoin Fetal Exposures in an Integrated Health Care System’, Journal of the American Academy of Dermatology, 65 (6): 11171125.Google Scholar
Smith, A. (1776 [1976]), An Inquiry into the Nature and Causes of the Wealth of Nations, Indianapolis, IN: Liberty Fund.Google Scholar
Smith, P. C., Stephan, A., Valdmanis, V., and Verheyen, P. (1997), ‘Principal-Agent Problems in Health Care Systems: An International Perspective’, Health Policy, 41 (1): 3760.Google Scholar
Stashhower, M. (2003), ‘Pregnancy Rates Associated with Isotretinoin (Accutane) and the FDA’, Journal of the American Academy of Dermatology, 49 (6): 12021203.Google Scholar
Stossel, T. (2015), Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation, Lanham, MD: Rowman and Littlefield.Google Scholar
Stringham, E. P. (2015), Private Governance Creating Order in Economic and Social Life, New York, NY: Oxford University Press.Google Scholar
Tabarrok, A. (2000), ‘Assessing the FDA Via the Anomaly of Off-Label Drug Prescription’, The Independent Review, 5 (1): 2553.Google Scholar
Tullock, G. (1965). The Politics of Bureaucracy, New York City, NY: Public Affairs Press.Google Scholar
Uhl, K., Trontell, A., and Kennedy, D. (2007), ‘Risk Minimization Practices for Pregnancy Prevention: Understanding Risk, Selection Tools’, Pharmacoepidemiology and Drug Safety, 16 (3): 337348.Google Scholar
Walker, S. (2007), ‘Memorandum for Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Members and Consultants’, [online] http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4311b1-01-fda.pdf (accessed April 2016).Google Scholar
Ward, M. (1992), ‘Drug Approval Overregulation’, Regulation, 15 (2): 4753.Google Scholar
Werner, C. A., Papic, M. J., Ferris, L. K., and Schwarz, E. B. (2015), ‘Promoting safe use of isotretinoin by increasing contraceptive knowledge’, Journal of the American Medical Association: Dermatology, 151 (4): 389393.Google Scholar
Woodcock, J. (2002), ‘Concerns Regarding Accutane (Isotretinoin)’, [online] http://www.fda.gov/NewsEvents/Testimony/ucm115126.htm (accessed April 2016).Google Scholar
Wysowski, D. K., Swann, J., and Vega, A. (2002), ‘Use of Isotretinoin (Accutane) in the United States: Rapid Increase from 1992 Through 2000’, Journal of the American Academy of Dermatology, 46 (4): 505509.Google Scholar
Zomerdijk, I. M., Ruiter, R., Houweling, L. M. A., Herings, R. M. C., Sturkenboom, M. C. J. M, Strauss, S. M. J. M., and Stricker, B. H. (2014), ‘Isotretinoin Exposure During Pregnancy: A Population-Based Study in the Netherlands’, BJM Open, 4 (11): 17.Google Scholar