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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

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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.

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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.

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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.

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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.”

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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.

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

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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.

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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.”

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