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Policy Punctuations and Regulatory Drug Review

Published online by Cambridge University Press:  27 April 2009

Stephen J. Ceccoli
Stephen J. Ceccoli
Affiliation:
Rhodes College, Memphis
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Extract

The FDA has dramatically decreased the regulatory review time for new drugs since the early 1990s. For example, according to the Tufts University Center for the Study of Drug Development (CSDD), which conducts triennial analyses of new drug approvals in the United States, the average FDA review time for approved New Chemical Entities (NCEs) decreased from 35.6 months in 1984–86 to 16.8 months in 1996–98. Thus, in a little more than a decade, the FDA has essentially cut its average review time in half. In addition to the declining review times, the agency's workload, as measured in terms of the number of drugs approved each year, also rose considerably in the 1990s. Specifically, the agency approved a total of 232 NCEs between 1993 and 1999, compared to just 163 approvals during the previous seven-year span—a 42 percent increase. Figures 1 and 2 illustrate the agency's decreased review times and increased workload, respectively. Thus, over the past decade the FDA has approved more drugs and done so in less time than at any other period in history. Simply stated, this change in regulatory performance, especially the declining review times, has been absolutely stunning.

Type
Articles
Information
Journal of Policy History , Volume 15 , Issue 2 , April 2003 , pp. 157 - 191
Copyright
Copyright © The Pennsylvania State University, University Park, PA. 2003

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References

Notes

1. Kaitin, Kenneth and Healy, Elaine, “The New Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee Area,” Drug Information Journal 34 (2000): 1–14CrossRefGoogle Scholar.

2. The measure of annual approvals is only one measure of agency workload and is used for illustrative purposes in this case. Workload is generally better measured by the number of submissions to the agency—INDs and NDAs for drugs, INDs and BLAs for biologics, and IDEs, PMAs, and 510(k)'s for medical devices, than by approvals.

3. Willman, David, “The New FDA,” Los Angeles Times, 20 12 2000, A-1Google Scholar.

4. Exceptions include the work of Daniel Carpenter and Mary Olson. See, for example, Olson, Mary, “Regulatory Agency Discretion Among Competing Industries: Inside the FDA,” Journal of Law Economics and Organization 11, no. 2 (1995): 379–405Google Scholar; idem, “Substitution in Regulatory Agencies: FDA Enforcement Alternatives,” Journal of Law, Economics, and Organization 12, no. 2 (1996): 376–407; idem, “Firm Characteristics and the Speed of FDA Approval,” Journal of Managerial and Decision Economics (1997); Carpenter, Daniel, “Bureaucratic Choice as a Stopping Problem: A Theoretical and Empirical Analysis of FDA Drug Review,”paper presented at the 1999 annual meeting of the Midwest Political Science Association,ChicagoGoogle Scholar; idem, “Groups, the Media, and Agency Waiting Costs: The Political Economy of FDA Drug Approval,” paper presented at the 2000 annual meeting of the Midwest Political Science Association, Chicago.

5. Sabatier, Paul and Jenkins-Smith, Hank, “The Advocacy Coalition Framework: An Assessment,” in Sabatier, Paul, ed., Theories of the Policy Process (Boulder, 1999), 118Google Scholar.

6. Baumgartner, Frank and Jones, Bryan, Agendas and Instability in American Politics (Chicago, 1993), 7Google Scholar; see also Baumgartner, Frank and Jones, Bryan, “Policy Dynamics,”paper presented at the Annual Meeting of the Midwest Political Science Association,18–21 April 2001Google Scholar.

7. The explanation is based on a combination of primary and secondary data sources. Much of the primary source data is derived from original documents such as congressional hearing transcripts and interviews by the author with key persons involved in the regulation of new medicines. The author has conducted interviews with more than thirty agency officials, industry executives, and industry analysts over the past few years. In every instance, open-ended questions were used and the author conducted focused interviews. That is, the author approached each interview with a prepared list of topics and questions. In some cases, interviewees preferred to receive a list of questions and topics in advance. Given the variety of interviewees, a standard list of questions was not used for every interview. The majority of interviews were conducted face to face, and the remainder were conducted over the telephone.

8. This illustration is also used in Grabowski, Henry and Vernon, John, The Regulation of Pharmaceuticals (Washington, D.C., 1983)Google Scholar, and Heimann, C. F. Larry, Acceptable Risks: Politics, Policy, and Risky Technologies (Ann Arbor, 1997)Google Scholar.

9. Technically speaking, this is not always a binary decision situation. In some cases, the agency may take a middle position by deciding that a particular drug is “approvable” if further studies support the drug's safety and efficacy.

10. McPhee, William, Formal Theories of Mass Behavior (New York, 1963), 29Google Scholar.

11. Heimann, Acceptable Risks.

12. See, for example, some of the early drug-lag literature (e.g., Wardell, 1973; 1978) and the response of FDA personnel (e.g., Kennedy, 1978).

13. Ward, Michael, “Drug Approval Overregulation,” Regulation (Fall 1992): 47–53Google Scholar.

14. Gieringer, Dale, “The Safety and Efficacy of New Drug Approval,” Cato Journal 5 (1985): 177–201Google ScholarPubMed.

15. Kingdon, John, Agendas, Alternatives, and Public Policies (New York, 1984)Google Scholar; Cobb, Roger and Elder, Charles, Participation in American Politics: The Dynamics of Agenda-Building (Baltimore, 1983)Google Scholar.

16. Baumgartner and Jones, Agendas and Instability in American Politics, 3.

17. Truman, David, The Governmental Process (New York, 1951)Google Scholar.

18. Huntington, Samuel, “The Marasmus of the Interstate Commerce Commission.” Yale Law Journal 61 (1952): 470CrossRefGoogle Scholar.

19. Herring, Edward P., Public Administration and the Public Interest (New York, 1936), 194Google Scholar.

20. Related empirical work utilizing this framework includes Lowry, William, The Capacity for Wonder (Washington, D.C., 1994)Google Scholar; Moe, Terry, “Control and Feedback in Economic Regulation: The Case of the NLRB,” American Political Science Review 79 (1985): 1094–1117CrossRefGoogle Scholar; Weingast, Barry and Moran, Mark, “Bureaucratic Discretion or Congressional Control? Regulatory Policy Making by the Federal Trade Commission,” in Mackay, R., Miller, J., and Yandle, B., eds., Public Choice and Regulation: A View from the Federal Trade Commission (Stanford, 1987), 1253–1282Google Scholar; Noll, Roger, “Government Regulatory Behavior: A Multidisciplinary Survey and Synthesis,” in Noll, R. ed., Regulatory Policy and the Social Sciences (Berkeley and Los Angeles, 1985), 41.Google Scholar

21. Bernstein, Marver, Regulating Business by Independent Commission (Princeton, 1955), 83CrossRefGoogle Scholar.

22. Eisner, Marc, Regulatory Politics in Transition, 2d ed. (Baltimore, 2000)Google Scholar.

23. Harris, Richard and Milkis, Sidney, The Politics of Regulatory Change: A Tale of Two Agencies (New York, 1996), 24Google Scholar.

24. Shepsle, Kenneth, “Institutional Arrangements and Equilibrium in Multidimensional Voting Models,” American Journal of Political Science 23 (1989): 27–59CrossRefGoogle Scholar.

25. Baumgartner, and Jones, , Agendas and Instability in American Politics, 1993Google Scholar.

26. In doing so, they emphasize the importance of both positive and negative feedback systems. For a review, see Pierson, Paul, “Increasing Returns, Path Dependence, and the Study of Politics,” American Political Science Review 94, no. 2 (2001): 251–267CrossRefGoogle Scholar.

27. Subsequent work by Jones, Bryan, Baumgartner, Frank, and True, James, “Policy Punctuations: U.S. Budget Authority, 1947–1995,” Journal of Politics 60, no. 1 (1998): 1–33CrossRefGoogle Scholar, refers to this phenomenon as a “policy punctuation.”

28. Lindblom, Charles, “The Science of ‘Muddling Through,’” Public Administration Review 29 (1959): 79–88CrossRefGoogle Scholar; Wildavsky, Aaron, The Politics of the Budgetary Process (Boston, 1964)Google Scholar; Carpenter, Daniel, “Adaptive Signal Processing, Hierarchy, and Budgetary Control in Federal Regulation,” American Political Science Review 90 (1996): 283–302CrossRefGoogle Scholar; True, James, “Attention, Inertia, and Equity in the Social Security Program,” Journal of Public Administration Research and Theory 9, no. 4 (1999): 571–596CrossRefGoogle Scholar.

29. Kingdon, Agendas, Alternatives, and Public Policies; Birkland, Thomas, After Disaster (Washington, D.C., 1997)Google Scholar.

30. Jones, Baumgartner, and True, “Policy Punctuations,” 2.

31. Sabatier and Jenkins-Smith, Theories of the Policy Process, 148.

32. Grabowski and Vernon, The Regulation of Pharmaceuticals.

33. Herring, Public Administration and the Public Interest.

34. Grabowski and Vernon, The Regulation of Pharmaceuticals, 8.

35. The efficacy criterion requires that the therapeutic effects of the drug are consistent with manufacturers' claims and are superior to a placebo.

36. Grabowski and Vernon, The Regulation of Pharmaceuticals, 9.

37. Sabatier and Jenkins-Smith, Theories of the Policy Process.

38. For example, Senator Orrin Hatch, the ranking Republican on the Labor and Human Resources Committee, acknowledged the agency's lack of resources during a 1991 hearing by pointing out that the FDA was scattered among thirty-two different buildings at eleven sites in Washington, including one lab that was “a converted chicken coup built in 1933.” See U.S. Senate, “Advisory Committee on the FDA: Final Report.” Senate Committee on Labor and Human Resources, S. Hrg. 102–1164 (15 May 1991), 3.

39. Burkholz, Herbert, FDA Follies (New York, 1994)Google Scholar; Kessler, David, A Question of Intent (New York, 2001)Google Scholar.

40. Discussion of legislative and administrative changes is largely based on reviews contained in U.S. Food and Drug Administration, FDA Consumer Special Report, 1995a, “From Test Tube to Patient: New Drug Development in the United States.” 2d ed., January 1995, and Federal Register, vol. 57, no. 73, 15 April 1992, pp. 13234–42.

41. 57 FR 13234 12/11/92.

42. Specific guidelines are provided in the FDA's Center for Drug Evaluation (CDER) Manual of Policies and Procedures (MaPP 6020.3)

43. See Merrill, Richard, “Modernizing the FDA: An Incremental Revolution,” Health Affairs (03–04 1999)Google Scholar, for a thorough review and evaluation of FDAMA.

44. Specific statistical aspects of the agency's recent performance have been documented empirically and in much greater detail elsewhere. See, for example, Kaitin and Healy, “The New Drug Approvals of 1996, 1997, and 1998.”

45. Lazarou, J., Pomeranz, B. H., and Corey, P. N., “Incidence of Adverse Drug Reactions in Hospital Patients,” JAMA 279, no. 15 (1998): 1200–1205CrossRefGoogle Scholar.

46. Friedman, M., Woodcock, J., Lumpkin, M., Shuren, J., Hass, A., Thompson, L., “The Safety of Newly Approved Medicines—Do Recent Market Removals Mean There Is a Problem?” JAMA 281 (1999): 1728–1734CrossRefGoogle ScholarPubMed; and Rubin, R., “Policy Speeds Approval, but Some Say It's Risky,” USA Today (10–12 07 1998), 1–2Google Scholar.

47. Landau, Richard, ed., Regulating New Drugs (Chicago, 1973)Google Scholar.

48. For a thorough review, see Shulman, Sheila, Hewitt, Peg, and Manocchia, Michael, “Studies and Inquiries into the FDA Regulatory Process: An Historical Review,” Drug Information Journal 29, no. 2 (04–06 1995): 385–414CrossRefGoogle Scholar.

49. U.S. Department of Health, Eduation, and Welfare, Review Panel, “Review Panel on New Drug Regulation, Final Report,” Norman Dorsen, Chairman, May 1977, 1.

50. For instance, the McMahon Committee (1982) considered IND requirements and the efficacy standard in the attempt to accelerate clinical testing and the Lasagna Committee (1990) examined procedures for reviewing AIDS and cancer drugs.

51. Heimann, , Acceptable Risks, 1997Google Scholar.

52. Kessler, A Question of Intent, 403.

53. U.S. Department of Health and Human Services, Advisory Committee on the Food and Drug Administration, “Final Report of the Advisory Committee on the Food and Drug Administration” (May 1991).

54. See Kessler, A Question of Intent.

55. Kessler, A Question of Intent, 38.

56. Epstein, Steve, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley and Los Angeles, 1996), 8Google ScholarPubMed.

57. Ibid.

58. Kwitny, Jonathan, Acceptable Risks (New York, 1992)Google Scholar; and Clark, Cheryl, “A Tenacious AIDS Activist Credited for Quicker OK of Drugs,” San Diego Union-Tribune, 12 11 1989, A-3Google Scholar.

59. Duggan, Paul, “1,000 Swarm FDA's Rockville Office to Demand Approval of AIDS Drugs,” Washington Post, 12 10 1988, B1Google Scholar; Leary, Warren, “FDA Pressed to Approve More AIDS Drugs,” New York Times, 11 10 1988, C5Google Scholar; and idem, “FDA Announces Changes to Speed Testing of New Drugs,” New York Times, 20 October 1988, A1.

60. Price, Deb, “‘ACT UP’ Group Uses Rage to Fight AIDS Complacency,” Gannett News Service, 23 11 1990Google Scholar.

61. Vogel, David, Fluctuating Fortunes (New York, 1989), 299Google Scholar; Lindblom, Charles, Politics and Markets (New York, 1977)Google Scholar.

62. President's Private-Sector Survey on Cost Control (PPSSCC), Report on User Charges U.S. Government Printing Office (Spring–Fall 1983).

63. Ibid., 275.

64. U.S. Senate, “Advisory Committee on the FDA: Final Report,” Senate Committee on Labor and Human Resources, S. Hrg. 102–1164 (15 May 1991), 16.

65. The Pharmaceutical Manufacturers Association would later become the Pharmaceutical Research and Manufacturers Association.

66. Interview with author.

67. Seachrist, Lisa, “Sen. Jeffords PDUFA / FDA Reform Bill Dodges Contentious Issues,” Bioworld Today 8, no. 103 (1997)Google Scholar.

68. U.S. Senate, “Food and Drug Administration Performance and Accountability Act of 1995,” Report 104–284, 104th Cong., 2d sess., 20 June 1996, 66.

69. Seachrist, “Sen. Jeffords PDUFA / FDA Reform Bill Dodges Contentious Issues.”

70. Lindblom, Charles, The Intelligence of Democracy (New York, 1965)Google Scholar; Peacock, Alan, The Regulation Game (Oxford, 1984)Google Scholar.