The FDA and Regulation of Cost-Effectiveness Claims

Health Affairs

Volumn 15, Issue 3, 1996, Pages 54-71

  Neumann, Peter J ^a   Zinner, Darren E ^b   Paltiel, A David ^c  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b Harvard Medical Technology Program

^c Sch of Public Health and Management

Author keywords

[No Author keywords available]

Indexed keywords

STREPTOKINASE; TISSUE PLASMINOGEN ACTIVATOR;

ARTICLE; COST BENEFIT ANALYSIS; DRUG COST; DRUG INDUSTRY; ECONOMICS; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; PHARMACOECONOMICS; STATISTICAL MODEL; UNITED STATES;

COST-BENEFIT ANALYSIS; DRUG COSTS; DRUG INDUSTRY; ECONOMICS, PHARMACEUTICAL; HUMANS; MODELS, ECONOMIC; PRIVATE SECTOR; STREPTOKINASE; TISSUE PLASMINOGEN ACTIVATOR; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0005671378     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.15.3.54     Document Type: Article

References (53)

1. R. Evans, "Manufacturing Consensus, Marketing Truth: Guidelines for Economic Evaluation," Annals of Internal Medicine 123, no. 1 (1995); 59-60; A. Hillman et al., "Avoiding Bias in the Conduct and Reporting of Cost-Effectiveness Research Sponsored by Pharmaceutical Companies," The New England Journal of Medicine 324, no. 19 (1991): 1362-1365; and J. Kassirer and M. Angell, "The Journal's Policy on Cost-Effectiveness Analyses," The New England Journal of Medicine 331, no. 10 (1994): 669-670.
2. R. Evans, "Manufacturing Consensus, Marketing Truth: Guidelines for Economic Evaluation," Annals of Internal Medicine 123, no. 1 (1995); 59-60; A. Hillman et al., "Avoiding Bias in the Conduct and Reporting of Cost-Effectiveness Research Sponsored by Pharmaceutical Companies," The New England Journal of Medicine 324, no. 19 (1991): 1362-1365; and J. Kassirer and M. Angell, "The Journal's Policy on Cost-Effectiveness Analyses," The New England Journal of Medicine 331, no. 10 (1994): 669-670.
3. R. Evans, "Manufacturing Consensus, Marketing Truth: Guidelines for Economic Evaluation," Annals of Internal Medicine 123, no. 1 (1995); 59-60; A. Hillman et al., "Avoiding Bias in the Conduct and Reporting of Cost-Effectiveness Research Sponsored by Pharmaceutical Companies," The New England Journal of Medicine 324, no. 19 (1991): 1362-1365; and J. Kassirer and M. Angell, "The Journal's Policy on Cost-Effectiveness Analyses," The New England Journal of Medicine 331, no. 10 (1994): 669-670.
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5. J. Eisenberg, "Why a Journal of Pharmacoeconomics?" PharmacoEconomics 1, no. I (1992): 2-4; A. Elixhauser et al., "Health Care CBA/CEA: An Update on the Growth and Composition of the Literature," Medical Care 31, no. 17 (1993): JS1 ; and C. Bradley et al., "Quality Assessment of Economic Evaluations in Selected Pharmacy, Medical, and Health Economics Journals," The Annals of Pharmacotherapy 29 (1995): 681-689
6. J. Eisenberg, "Why a Journal of Pharmacoeconomics?" PharmacoEconomics 1, no. I (1992): 2-4; A. Elixhauser et al., "Health Care CBA/CEA: An Update on the Growth and Composition of the Literature," Medical Care 31, no. 17 (1993): JS1 ; and C. Bradley et al., "Quality Assessment of Economic Evaluations in Selected Pharmacy, Medical, and Health Economics Journals," The Annals of Pharmacotherapy 29 (1995): 681-689
7. The Changing Environment for U.S. Pharmaceuticals (New York: The Boston Consulting Group, Inc., 1993).
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9. D. Kessler et al., "Therapeutic-Class Wars - Drug Promotion in a Competitive Marketplace," The New England Journal of Medicine 331, no. 20 (1994): 1350-1353.
10. D. Kessler and W. Pines, "The Federal Regulation of Prescription Drug Advertising and Promotion," Journal of the American Medical Association 264, no. 18 (1990): 2409-2415.
11. Ibid.
12. Code of Federal Regulations, 1994, secs. 201, 202.
13. Kuhlik, "The FDA's Regulation of Pharmaceutical Communications."
14. J. Rose, "Regulating Cost Effectiveness Claims" (Presentation at the Food and Drug Administration conference, "Comparing Treatments: Safety, Effectiveness, and Cost-Effectiveness," Bethesda, Maryland, 24 March 1995).
15. Ibid.
16. FDA, Division of Drug Marketing, Advertising, and Communications, "Principles for the Review of Pharmacoeconomic Promotion" (Draft guidelines, 1995).
17. S. Peltzman, "An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments," Journal of Political Economy 81 (1973): 1049; and H. Grabowski and J. Vernon, The Regulation of Pharmaceuticals: Balancing the Benefits and Risks (Washington: American Enterprise Institute, 1983).
18. S. Peltzman, "An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments," Journal of Political Economy 81 (1973): 1049; and H. Grabowski and J. Vernon, The Regulation of Pharmaceuticals: Balancing the Benefits and Risks (Washington: American Enterprise Institute, 1983).
19. M. Weinstein and W. Stason, "Foundations of Cost-Effectiveness Analysis for Health and Medical Practices," The New England Journal of Medicine 296, no. 13 (1977): 716-721; and M. Drummond, G. Stoddart, and G. Torrance, Methods for the Economic Evaluation of Health Care Programmes (Oxford, England: Oxford University Press, 1987).
20. M. Weinstein and W. Stason, "Foundations of Cost-Effectiveness Analysis for Health and Medical Practices," The New England Journal of Medicine 296, no. 13 (1977): 716-721; and M. Drummond, G. Stoddart, and G. Torrance, Methods for the Economic Evaluation of Health Care Programmes (Oxford, England: Oxford University Press, 1987).
21. M. Drummond and L. Davies, "Economic Analysis alongside Clinical Trials: Revisiting the Methodological Issues," International Journal of Technology Assessment in Healthcare 7, no. 4 (1991): 561-573.
22. J. Siegel and M. Roberts, "Reforming FDA Policy: Lessons from the AIDS Experience," Regulation (Fall 1991): 71-77.
23. Kuhlik, "The FDA's Regulation of Pharmaceutical Communications."
24. M. Shepherd and R. Salzman, "The Formulary Decision-Making Process in a Health Maintenance Organization Setting," PharmacoEconomics 5, no. 1 (1994): 29-38.
25. P.J. Neumann and M. Johannesson, "From Principle to Public Policy: Using Cost-Effectiveness Analysis," Health Affairs (Summer 1994): 206-214.
26. J. Lax and E. Moench, "Pharmacoeconomics and Managed Care: Understanding the Issues, Concerns, and the Environment," and W. Zellmer, "Comments of the American Society of Health-System Pharmacists" (Presentations at the FDA public hearing, "Pharmaceutical Marketing and Information Exchange in Managed Care Environments," Silver Spring, Maryland, 19 October 1995). In the survey of health system pharmacists by William Zellmer and colleagues, for example, only 60 percent of respondents believed that their managed care organization was "well equipped to critically analyze the comparative pharmacoeconomic claims of drug manufacturers," and only 18 percent believed that "comparative pharmacoeconomic claims made by drug manufacturers generally meet high standards for reliability."
27. J. Lax and E. Moench, "Pharmacoeconomics and Managed Care: Understanding the Issues, Concerns, and the Environment," and W. Zellmer, "Comments of the American Society of Health-System Pharmacists" (Presentations at the FDA public hearing, "Pharmaceutical Marketing and Information Exchange in Managed Care Environments," Silver Spring, Maryland, 19 October 1995). In the survey of health system pharmacists by William Zellmer and colleagues, for example, only 60 percent of respondents believed that their managed care organization was "well equipped to critically analyze the comparative pharmacoeconomic claims of drug manufacturers," and only 18 percent believed that "comparative pharmacoeconomic claims made by drug manufacturers generally meet high standards for reliability."
28. FTC Bureaus of Economics and Consumer Protection, In the Matter of Pharmaceutical Marketing and Information Exchange in the Managed Care Environments: Public Hearings, Docket no. 95N-0228 (Washington: FTC, 16 January 1996), 15.
29. Task Force on Principles for Economic Analysis of Health Care Technology, "Economic Analysis of Health Care Technology: A Report on Principles," Annals of Internal Medicine 123, no. 1 (1995): 61-70; and M. Gold et al., Cost-Effectiveness in Health and Medicine: Report of the Panel on Cost-Effectiveness in Health and Medicine (New York: Oxford University Press, 1996).
30. Task Force on Principles for Economic Analysis of Health Care Technology, "Economic Analysis of Health Care Technology: A Report on Principles," Annals of Internal Medicine 123, no. 1 (1995): 61-70; and M. Gold et al., Cost-Effectiveness in Health and Medicine: Report of the Panel on Cost-Effectiveness in Health and Medicine (New York: Oxford University Press, 1996).
31. Evans, "Manufacturing Consensus, Marketing Truth."
32. Gold et al., Cost-Effectiveness in Health and Medicine.
33. J. Gagnon, "A Primer on Pharmacoeconomics," Managed Care Medicine 2 (1995): 11-18.
34. Pharmaceutical Research and Manufacturers of America, Methodological and Conduct Principles for Pharmacoeconomic Research (Washington: PhRMA, January 1995).
35. Task Force, "Economic Analysis of Health Care Technology."
36. F. Sloan, K. Whetten-Goldstein, and A. Wilson, "Use of Cost-Effectiveness Analysis in U.S. Hospitals" (Presentation at the "Conference for Cost-Effectiveness Analysis in Decisionmaking," Duke University, Durham, North Carolina, 29 November 1995).
37. I. Udvarhelyi et al., "Cost-Effectiveness and Cost-Benefit Analyses in the Medical Literature," Annals of Internal Medicine 116, no. 3 (1992): 238-244; and Bradley et al., "Quality Assessment of Economic Evaluations."
38. I. Udvarhelyi et al., "Cost-Effectiveness and Cost-Benefit Analyses in the Medical Literature," Annals of Internal Medicine 116, no. 3 (1992): 238-244; and Bradley et al., "Quality Assessment of Economic Evaluations."
39. Kassirer and Angell, "The Journal's Policy on Cost-Effectiveness Analyses."
40. Gold et al., Cost-Effectiveness in Health and Medicine.
41. A similar suggestion was made by Bryan Luce in testimony at the FDA hearing, "Pharmaceutical Marketing and Information Exchange."
42. J. Beales, "FDA Regulation of Pharmaceutical Advertising: Economic Analysis and the Regulation of Pharmaceutical Advertising," Seton Hall Law Review 24 (1994): 1370.
43. Ibid; and J. Calfee, Some Economic Aspects of Cost-Effectiveness Research and Its Dissemination in the Health Care Market, Public Comments to the FDA (Washington: American Enterprise Institute, January 1996).
44. Ibid; and J. Calfee, Some Economic Aspects of Cost-Effectiveness Research and Its Dissemination in the Health Care Market, Public Comments to the FDA (Washington: American Enterprise Institute, January 1996).
45. Beales, "FDA Regulation of Pharmaceutical Advertising;" and J. Calfee, "The Leverage Principle in FDA's Regulation of Information," in Competitive Strategies in the Pharmaceutical Industry, ed. R. Helms (Washington: American Enterprise Institute, 1994).
46. Beales, "FDA Regulation of Pharmaceutical Advertising;" and J. Calfee, "The Leverage Principle in FDA's Regulation of Information," in Competitive Strategies in the Pharmaceutical Industry, ed. R. Helms (Washington: American Enterprise Institute, 1994).
47. The GUSTO Investigators, "An International Randomized Trial Comparing Four Thrombolytic Strategies for Acute Myocardial Infarction," The New England Journal of Medicine 329, no. 10 (1993): 673-682.
48. For example, see Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico, "GISSI-2: A Factorial Randomised Trial of Alteplase versus Streptokinase and Heparin versus No Heparin among 12,490 Patients with Acute Myocardial Infarction," The Lancet 336, no. 8707 (1990): 65-71; and The International Study Group, "In-Hospital Mortality and Clinical Course of 20,891 Patients with Suspected Acute Myocardial Infarction Randomised between Alteplase and Streptokinase with or without Heparin," The Lancet 336, no. 8707 (1990): 71-75. For market share information, see M. Chase, "Technology and Health: Study Supporting Genentech's Activase Is Being Investigated by House Panel," The Wall Street Journal 12 May 1994, B3.
49. For example, see Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico, "GISSI-2: A Factorial Randomised Trial of Alteplase versus Streptokinase and Heparin versus No Heparin among 12,490 Patients with Acute Myocardial Infarction," The Lancet 336, no. 8707 (1990): 65-71; and The International Study Group, "In-Hospital Mortality and Clinical Course of 20,891 Patients with Suspected Acute Myocardial Infarction Randomised between Alteplase and Streptokinase with or without Heparin," The Lancet 336, no. 8707 (1990): 71-75. For market share information, see M. Chase, "Technology and Health: Study Supporting Genentech's Activase Is Being Investigated by House Panel," The Wall Street Journal 12 May 1994, B3.
50. For example, see Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico, "GISSI-2: A Factorial Randomised Trial of Alteplase versus Streptokinase and Heparin versus No Heparin among 12,490 Patients with Acute Myocardial Infarction," The Lancet 336, no. 8707 (1990): 65-71; and The International Study Group, "In-Hospital Mortality and Clinical Course of 20,891 Patients with Suspected Acute Myocardial Infarction Randomised between Alteplase and Streptokinase with or without Heparin," The Lancet 336, no. 8707 (1990): 71-75. For market share information, see M. Chase, "Technology and Health: Study Supporting Genentech's Activase Is Being Investigated by House Panel," The Wall Street Journal 12 May 1994, B3.
51. D.B. Mark et al, "Cost-Effectiveness of Thrombolytic Therapy with Tissue Plasminogen Activator as Compared with Streptokinase for Acute Myocardial Infarction," The New England Journal of Medicine 332, no. 21 (1995): 1418-1424.
52. L. Altman, "A Costlier Heart Drug Also Proves Better," The New York Times, 1 May 1993, C1.
53. Siegel and Roberts, "Reforming FDA Policy."