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An International Comparison of the Approval of New Pharmaceuticals

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Book cover Managing Technology in Healthcare

Part of the book series: Management of Medical Technology ((MOMT,volume 1))

Abstract

In this paper we analyze differences in the timing of approval of important pharmaceuticals in France and the United States between the years 1970 and 1988. Our hypothesis is that the timing of approvals will be similar in both countries because of their similar approval processes and objectives. We analyze differences in the delays over time, by the a priori assessment by the FDA concerning a drug’s innovativeness, and by drug therapeutic category. We test the hypotheses, for example, that US approvals would be relatively fast for drugs which the FDA had initially designated as particularly innovative, and for drugs treating cardiovascular illnesses, the disease group with the highest age-adjusted mortality rate. The observation that one country consistently lagged behind the other in approving new drugs might indicate that the lagging country is either more rigorous, or perhaps less efficient, than the other.

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References

  1. Organization for Economic Cooperation and Development, Health Care Systems in Transition: The Search for Efficiency, Paris: OECD, 1990.

    Google Scholar 

  2. Peltzman S, “An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments,” Journal of Political Economy 8:1049–1091, 1973.

    Article  Google Scholar 

  3. Wiggins SN, “Product Availability Regulation and New Drug Introductions: Some New Evidence from the 1970s,” Review of Economics and Statistics 63:615–619, 1981.

    Article  Google Scholar 

  4. Thomas LG, “Regulation and Firm Size: FDA Impacts on Innovation,” RAND Journal of Economics 21:4(497–517), Winter 1990.

    Article  Google Scholar 

  5. Grabowski HG, Vernon JM, and Thomas LG, “Estimating the Effects of Regulation on Innovation: An International Comparative Analysis of the Pharmaceutical Industry,” Journal of Law and Economics 2:133–163, 1978.

    Article  Google Scholar 

  6. Grabowski HG, “Regulation and the International Diffusion of Pharmaceuticals,” in Helms RB (ed), The International Supply of Medicines: Implications of U.S. Regulatory Reform, (pp. 5–36), Washington, DC, American Enterprise Institute for Public Policy Research, Washington DC, 1980.

    Google Scholar 

  7. Burstall ML, “Europe after 1992: Implications for Pharmaceuticals,” Health Affairs, 157–171, Fall 1991.

    Google Scholar 

  8. Fielding JE and Lancry PJ, “Lessons from France — ‘Vive la Difference’: The French Health Care System and US Health System Reform,” Journal of the American Medical Association 270(6): 748–756, August 11, 1993.

    Article  Google Scholar 

  9. Rodwin VG and Sandier S, “Health Care under French National Health Insurance,” Health Affairs 12(3):111–131, Fall 1993.

    Article  Google Scholar 

  10. Andersson F, “The Drug Lag Issue: The Debate Seen From An International Perspective,” International Journal of Health Services, 22:53–72, 1992.

    Article  Google Scholar 

  11. Wardell WM, “Introduction of New Therapeutic Drugs in the United States and Great Britain: An International Comparison, Clinic. Pharmacol. Ther. 4: 773–790, 1973.

    Google Scholar 

  12. Wardell WM, “The Drug Lag Revisited: Comparison by Therapeutic Area of Patterns of Drugs Marketed in the United States and Great Britain from 1972 through 1976,” Clin. Pharmacol. Ther. 24:499–524, 1978.

    Google Scholar 

  13. Grabowski HG and Vernon JM, “Innovation and Invention — Consumer Protection Regulation in Ethical Drugs,” American Economic Review 67:359–364, 1977.

    Google Scholar 

  14. Berlin H and Jonsson B, “International Dissemination of New Drugs: A Comparative Study of Six Countries,” Managerial and Decision Economics 7:235–242, 1986.

    Article  Google Scholar 

  15. Kaitin K, “Reply to ‘Understanding Comparisons of Drug Introductions between the United States and the United Kingdom’” Clinical Pharmacological Therapeutics 46:146–148, 1989.

    Article  Google Scholar 

  16. Kaitin K et al., “The Drug Lag: An Update of New Drug Introductions in the United States and in the United Kingdom, 1977 through 1987,” Clinical Pharmacological Therapeutics 46:121–138, 1989.

    Article  Google Scholar 

  17. Simmons HE, “The Drug Regulatory System of the United States Food and Drug Administration: A Defense of Current Requirements for Safety and Efficacy, International Journal of Health Services 4:95–107, 1974.

    Article  Google Scholar 

  18. Coppinger PL, Peck CC, and Temple RJ, “Understanding Coimparisons of Drug Introductions between the United States and the United Kingdom,” Clin. Pharm. Ther. 46:139–145, 1989.

    Article  Google Scholar 

  19. Parker JES, “Who Has A Lag?” Managerial and Decision Economics 10:299–309, 1989.

    Article  Google Scholar 

  20. Parker JES, “Who Has A Lag?” J. Soc. Admin. Pharm., 6:138–152, 1989.

    Google Scholar 

  21. DeHaen P, “The Drug Lag — Does It Exist in Europe?” Drug Intell. Clin. Pharm. 9:144–150, 1975.

    Google Scholar 

  22. Parker JES, The International Diffusion of Pharmaceuticals, Macmillan, London, 1984.

    Google Scholar 

  23. Hass AE Jr, “Where Drug Marketing Patterns Are Similar,” Medical Marketing and Media 18:78–83, 1983.

    Google Scholar 

  24. Schweitzer S, Salehi H, and Boling N, “The Social Drug Lag,” Social Science and Medicine 21:10(1077–1082), 1985.

    Google Scholar 

  25. Grabowski HG, “Medicaid Patients’ Access to New Drugs,” Health Affairs 7:5(102–114), 1988.

    Article  Google Scholar 

  26. Grabowski HG, Schweitzer SO, and Shiota R, “The Effect of Medicaid Formularies on the Availability of New Drugs,” PharmacoEconomics 1 (supp):(32–40), 1992.

    Article  Google Scholar 

  27. Drug Facts and Comparisons, 1992 edition (St. Louis: Facts and Comparisons), 1992.

    Google Scholar 

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Eliezer Geisler Ori Heller

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© 1996 Kluwer Academic Publishers

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Schweitzer, S.O. (1996). An International Comparison of the Approval of New Pharmaceuticals. In: Geisler, E., Heller, O. (eds) Managing Technology in Healthcare. Management of Medical Technology, vol 1. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-1415-8_11

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  • DOI: https://doi.org/10.1007/978-1-4613-1415-8_11

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4612-8614-1

  • Online ISBN: 978-1-4613-1415-8

  • eBook Packages: Springer Book Archive

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