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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).

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43. See Porter, The Greatest Benefit to Mankind; Duffy, John, “The American Medical Profession and Public Health: From Support to Ambivalence,” Bulletin of the History of Medicine 53, no. 1 (Spring 1979): 1–22Google ScholarPubMed; and Liebenau, Jonathan, Medical Science and Medical Industry: The Formation of the American Pharmaceutical Industry (Baltimore, 1987).CrossRefGoogle Scholar

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50. Ibid., 19.

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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.

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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.