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Divergent Paths to Drug Regulation in the United States and the United Kingdom

Published online by Cambridge University Press:  27 April 2009

Stephen Ceccoli
Stephen Ceccoli
Affiliation:
Rhodes College, Memphis
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Extract

Significant differences in the availability of new medicines in the United States and the United Kingdom became apparent in the 1970s. This article examines the history of drug regulation in the two countries and argues that the divergence was the result of distinctive regulatory approaches that emerged simultaneously throughout the twentieth century. The British approach was based largely on informal, nonstatutory controls, while the American approach relied heavily on centralized regulatory controls. The article argues that the nature of business-government relations has played a significant role in the divergence. The impact of these divergent approaches is apparent in the contemporary regulatory framework, especially with respect to determining the effectiveness of new drugs.

Type
Articles
Information
Journal of Policy History , Volume 14 , Issue 2 , April 2002 , pp. 135 - 169
Copyright
Copyright © The Pennsylvania State University, University Park, PA. 2002

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References

Notes

1. U.S. Senate, Testimony for “Examination of the Pharmaceutical Industry, 1973–74,” Joint Hearings before Senate Committee on Labor and Public Welfare, Subcommittee on Health, and Senate Judiciary Committee, Subcommittee on Administrative Practice and Procedure,” pt. 7 (5, 16 August 1974).

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23. Quoted in the white paper “Forthcoming Legislation on the Safety, Quality, and Description of Drugs and Medicines,” Command Paper 3395 (London, September 1967), 1.

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30. Quoted from Parliamentary Debates (Hansard) House of Commons Official Report, Session 1962–63 (8 May 1963), 447–52.

31. Ibid., 747.

32. Cuthbert et al., “The United Kingdom.”

33. Pharmaceutical Journal, 1966:86.

34. Pharmaceutical Journal, 1967:59.

35. Pharmaceutical Journal, 1968:274.

36. “Forthcoming Legislation on the Safety, Quality, and Description of Drugs and Medicines,” Command Paper 3395 (London, September 1967).

37. U.S. Congress, Committee on Government Operations, The British Drug Safety System (Washington, D.C., 1970), 58.Google Scholar

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39. Smith, , Legal Regulation of the British Pharmaceutical Market, 21.Google Scholar

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45. Porter, The Greatest Benefit to Mankind.

46. Wiley, along with his volunteer “poison squad,” played an active and extremely influential role in developing various provisions in the legislation and urging its passage. For a discussion of Wiley's role as a bureaucratic entrepreneur, see Coppin, Clayton and High, Jack, “Entrepreneurship and Competition in the Bureaucracy: Harvey Washington Wiley's Bureau of Chemistry, 1883–1903,” in High, Jack, ed., Regulation: Economic Theory and History (Ann Arbor, 1991).Google Scholar

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48. Fried, Bitter Pills.

49. Duffy, “The American Medical Profession and Public Health: From Support to Ambivalence.”

50. Ibid., 19.

51. For a discussion of this debate, see Numbers, Ronald, Almost Persuaded: American Physicians and Compulsory Health Insurance, 1912–1920 (Baltimore, 1978).Google ScholarPubMed

52. Jackson, , Food and Drug Legislation in the New Deal, 17.Google Scholar

53. Liebenau, Medical Science and Medical Industry. One key difference, as Slinn (1995) notes, was the much larger size of American firms compared to British counterparts.

54. Reekie, , The Economics of the Pharmaceutical Industry, 24.Google Scholar

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56. Ibid., 45.

57. Perhaps the most succinct criticism of Delaney is offered by science writer Michael Fumento: “Let's say you detect a part per quadrillion in a plum product. That's the equivalent of one plum in 73,511,000 tons.” Michael Fumento, “Overdue Overhaul of Pesticide Limitations,” Washington Times, 13 December 1995, A19.

58. See Liebenau, Medical Science and Medical Industry.

59. For an illuminating account of the Kefauver drug hearings and a legislative history of the 1962 Drug Amendments, see Harris, Richard, The Real Voice (New York, 1964).Google Scholar

60. Though thalidomide was never officially marketed in the United States, it was used by an unknown number of Americans on an experimental basis. That thalidomide was never marketed here is perhaps not a coincidence. Much of the credit for keeping thalidomide out of the American market was given to FDA reviewer Dr. Frances Kelsey. The Merrell Corporation had submitted an application to the FDA to market thalidomide in the early 1960s, but Dr. Kelsey was skeptical of the drug's purported effectiveness and consistently pushed for the Merrell Corporation to provide additional safety data. To reward her regulatory persistence, President John Kennedy bestowed the prestigious Distinguished Presidential Service Award on Dr. Kelsey in 1962.

61. Despite Kefauver's original intent to pursue drug pricing and industry profits, the 1962 Amendments lacked such provisions. Though drug pricing has surfaced many times in subsequent congressional hearings and has long been a key source of suspicion in government-industry relations, it has managed to continually avoid being included in federal drug legislation.

62. Harris, The Real Voice.

63. Pharmaceutical Journal (1962): 344.Google Scholar

64. Ibid., 345.

65. Grabowski, Henry and Vernon, John, The Regulation of Pharmaceuticals (Washington, D.C., 1983).Google Scholar

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67. Grabowski, and Vernon, , The Regulation of Pharmaceuticals, 8.Google Scholar

68. See Arthur, Brian, Increasing Returns and Path Dependence in the Economy (Ann Arbor, 1994)CrossRefGoogle Scholar; Magnusson, Lars and Ottosson, Jan, eds., Evolutionary Economics and Path Dependence (Brookfield, Vt., 1997).Google Scholar

69. Lindblom, Charles, Politics and Markets (New York, 1977).Google Scholar

70. Vogel, National Styles of Regulation.

71. Vogel, David, “Why Businessmen Distrust Their State: The Political Consequences of American Corporate Executives,” British Journal of Political Science 8, no. 1 (1978): 45.CrossRefGoogle Scholar

72. For a long time, the “full reports of investigations” clause was interpreted by the agency to include all case report forms and case report tabulations among other things. The agency modified its interpretation in 1985 to slightly ease this interpretation.

73. U.S. House of Representatives, Committee on Government Operations, Subcommittee on Human Resources and Intergovernmental Relations, Council on Competitiveness and FDA Plans to Alter the Drug Approval Process at FDA (19 March 1992), 19.

74. Some data for this article comes from interviews conducted by the author with industry and regulatory professionals in London and Washington over the past few years.

75. See U.S. Congress, Office of Technology Assessment, Post Marketing Surveillance of Prescription Drugs, OTA-H-189, November 1982; U.S. House of Representatives, The Regulation of New Drugs by the Food and Drug Administration: The New Drug Review Process. Hearings Before the Subcommittee of the Committee on Government Operations (3–4 August 1982), 434–37.

76. See U.S. Food and Drug Administration, Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products, 1998.

77. Such scenarios include situations where information from supporting studies may be used or evidence may be extrapolated from existing students. This legislative provision, made easier because of significant advances in drug development, represents a substantial shift in the regulatory review process.