Modernizing the FDA: An incremental revolution

Health Affairs

Volumn 18, Issue 2, 1999, Pages 96-111

  Merrill, Richard A ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; DRUG APPROVAL; DRUG LABELING; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; UNITED STATES;

DRUG APPROVAL; DRUG LABELING; EQUIPMENT AND SUPPLIES; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 4243065621     PISSN: 02782715     EISSN: None     Source Type: Journal    
DOI: 10.1377/hlthaff.18.2.96     Document Type: Article

References (78)

1. C. Marwick, "Implementing the PDA Modernization Act," Journal of the American Medical Association 279, no. 11 (18 March 1998): 815.
2. R.A. Merrill, "Regulation of Drugs and Devices: An Evolution," Health Affairs (Summer 1994): 47-69.
3. Statement of Alexander M. Schmidt, commissioner of food and drugs, "Regulation of New Drug R&D by the Food and Drug Administration," at joint hearings before the Senate Subcommittee on Health Labor and Public Welfare and the Senate Judiciary Subcommittee on Administrative Practice and Procedure, 93d Cong., 2d sess. (1974).
4. Statement of Sam Peltzman, professor, University of Chicago Business School, before the Senate Small Business Subcommittee on Monopoly, 93d Cong., 1st sess. (1973).
5. M. Friedman, "Frustrating Drug Advancement," Newsweek, 8 January 1973, 49.
6. B. Brody, Ethical Issues in Drug Testing, Approval, and Pricing: The Clot-Dissolving Drugs (New York: Oxford University Press, 1995), 165-166.
7. Federal Register 52 (22 May 1987): 19466; and Federal Register 53 (21 October 1988): 41516.
8. Federal Register 52 (22 May 1987): 19466; and Federal Register 53 (21 October 1988): 41516.
9. P.B. Hutt and R.A. Merrill, Food and Drug Law: Cases and Materials, 2d ed. (Westbury, N.Y.: Foundation Press, 1991), 1284-1286.
10. Ibid., 552-566.
11. J. Benson, "Optimum Science for Product Review: An Industry Perspective," Food and Drug Law Journal 49, no. 2 (1994): 415; and R. Nowak, "Problems in Clinical Trials Go Far Beyond Misconduct," Science 264, no. 5165 (1994): 1538.
12. J. Benson, "Optimum Science for Product Review: An Industry Perspective," Food and Drug Law Journal 49, no. 2 (1994): 415; and R. Nowak, "Problems in Clinical Trials Go Far Beyond Misconduct," Science 264, no. 5165 (1994): 1538.
13. D. Kessler, "Remarks by the Commissioner of Food and Drugs," Food and Drug Low Journal 51, no. 2 (1996): 211-215; R. Merrill, "The Architecture of Government Regulation of Medical Products," Virginia Law Review 82, no. 8 (1996): 1840-1844; and "The FDA Cleared 139 Products in 1996, A Record Increase," Wall Street Journal, 15 January 1997, B5.
14. D. Kessler, "Remarks by the Commissioner of Food and Drugs," Food and Drug Low Journal 51, no. 2 (1996): 211-215; R. Merrill, "The Architecture of Government Regulation of Medical Products," Virginia Law Review 82, no. 8 (1996): 1840-1844; and "The FDA Cleared 139 Products in 1996, A Record Increase," Wall Street Journal, 15 January 1997, B5.
15. D. Kessler, "Remarks by the Commissioner of Food and Drugs," Food and Drug Low Journal 51, no. 2 (1996): 211-215; R. Merrill, "The Architecture of Government Regulation of Medical Products," Virginia Law Review 82, no. 8 (1996): 1840-1844; and "The FDA Cleared 139 Products in 1996, A Record Increase," Wall Street Journal, 15 January 1997, B5.
16. Federal Food, Drug, and Cosmetic Act, Sec. 736 (b) (1) (A).
17. Ibid, Sec. 736(g)(3).
18. Ibid, Sec. 736(f)(1) and Sec. 736(g).
19. Merrill, "The Architecture of Government Regulation of Medical Products," 1771-1772; and Hutt and Merrill, Food and Drug Low, 527.
20. Merrill, "The Architecture of Government Regulation of Medical Products," 1771-1772; and Hutt and Merrill, Food and Drug Low, 527.
21. FDCA, Sec. 505(d).
22. R. Alta Charo, "Protecting Us to Death: Women, Pregnancy, and Clinical Research Trials," Saint Louis University Law Journal 38, no. 1 (1993): 135-187.
23. M. Woods, "Minorities Absent from Too Many Medical Studies," Chicago Sun-Times, 27 May 1998, 59.
24. FDCA, Sec. 505(b)(1).
25. Ibid, Sec. 505A.
26. Federal Register 62 (15 August 1997): 43900; and J. Wechsler, "More Changes and Challenges at FDA," Pharmaceutical Executive (1 February 1998): 24.
27. Federal Register 62 (15 August 1997): 43900; and J. Wechsler, "More Changes and Challenges at FDA," Pharmaceutical Executive (1 February 1998): 24.
28. Hutt and Merrill, Food and Drug Law, 552-561.
29. FDCA,Sec.506.
30. Public Health Service Act, 42 U.S.C. 282, Sec. 402(j).
31. For a recent overview of FDA's advisory committee system, see Institute of Medicine, Food and Drug Administration Advisory Committees (Washington: National Academy Press, 1992).
32. Prescription Drug User Fee Reauthorization and Drug Regulatory Modernization Act of 1997, H.Rept. 105-310, 105th Cong., 1st sess. (1997), 73.
33. FDCA, Sec. 562.
34. R. Temple, "Development of Drug Law, Regulation, and Guidance in the United States," in Principles of Pharmacology: Basic Concepts and Clinical Applications, ed. P.L. Munson et al. (New York: Chapman and Hall, 1995), 1646-1647.
35. FDCA, Sec. 505(b)(4).
36. T. Hayes, "Drug Labeling and Promotion: Evolution and Application of Regulatory Policy," Food and Drug Law Journal 51, no. 1 (1996): 62-65.
37. Prescription Drug User Fee Reauthorization, 67.
38. "FDA Pharmacoeconomic Guidance to Reflect 'Needs of Managed Care,' Agency Says; Managed Care Does Not Yet Understand Its Information Needs," PinkSheet (12 January 1998): 15.
39. Prescription Drug User Fee Reauthorization, 67.
40. Federal Register 37 (15 August 1972): 16503; and N. Plant, "Prescription Drug Promotion on the Internet: Tool for the Inquisitive or Trap for the Unwary?" Saint Louis University Law Journal 42, no. 1 (1998): 92-99.
41. Federal Register 37 (15 August 1972): 16503; and N. Plant, "Prescription Drug Promotion on the Internet: Tool for the Inquisitive or Trap for the Unwary?" Saint Louis University Law Journal 42, no. 1 (1998): 92-99.
42. Washington Legal Foundation v Friedman, 13 F.Supp. 2d 51 (D.D.C. 1998).
43. FDCA, Sec. 554(c).
44. Ibid, Sec. 551(a).
45. Ibid, Sec. 556(5).
46. Ibid., Sec. 555(b) and Sec. 555(c). The FDA was to have promulgated final implementing regulations by November 1998, and studies of the impact of this new subchapter are elicited from the General Accounting Office and the Institute of Medicine. Ibid., Sec. 557(c) and Sec. 557(f). The FDA recently released proposed rules on the "Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices," Federal Register 63 (8 June 1998): 31143.
47. Ibid., Sec. 555(b) and Sec. 555(c). The FDA was to have promulgated final implementing regulations by November 1998, and studies of the impact of this new subchapter are elicited from the General Accounting Office and the Institute of Medicine. Ibid., Sec. 557(c) and Sec. 557(f). The FDA recently released proposed rules on the "Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices," Federal Register 63 (8 June 1998): 31143.
48. Ibid., Sec. 555(b) and Sec. 555(c). The FDA was to have promulgated final implementing regulations by November 1998, and studies of the impact of this new subchapter are elicited from the General Accounting Office and the Institute of Medicine. Ibid., Sec. 557(c) and Sec. 557(f). The FDA recently released proposed rules on the "Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices," Federal Register 63 (8 June 1998): 31143.
49. Merrill, "The Architecture of Government Regulation of Medical Products," 1802-1806; and Hutt and Merrill, Food and Drug Law, 742-744.
50. Merrill, "The Architecture of Government Regulation of Medical Products," 1802-1806; and Hutt and Merrill, Food and Drug Law, 742-744.
51. FDCA, Sec. 510(1), Sec. 510(m), 520(g), and Sec. 513(f).
52. Ibid., Sec. 519(b)(5)(A).
53. Ibid, Sec. 523.
54. Statement of David Kessler, FDA commissioner, at PDA Reform Legislation Hearings on H.R. 3199, H.R. 3100, and H.R. 3201, House Commerce Subcommittee on Health and Environment, 104th Cong., 2d sess. 84-337 (1996): 27, 28, 34; E. Price, "Teaching the Elephant to Dance: Privatizing the FDA Review Process," Food and Drug Low Journal 51, no. 4 (1996): 651-676; "Notice - Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program," Federal Register 61 (3 April 1996): 14789; "FDA Annual Report Reveals Good News: New Report Released March 1998; Highlights of Performance for FY 97: Part 5," Biomedical Markt Newsletter (31 March 1998): 1; and "Third-Party Review Pilot May Be Expanded to Include More Class II Devices, FDA's Alpert Says; Review Time Halved for First Two 510(k)s in Pilot," Gray Sheet (16 December 1996): 10.
55. Statement of David Kessler, FDA commissioner, at PDA Reform Legislation Hearings on H.R. 3199, H.R. 3100, and H.R. 3201, House Commerce Subcommittee on Health and Environment, 104th Cong., 2d sess. 84-337 (1996): 27, 28, 34; E. Price, "Teaching the Elephant to Dance: Privatizing the FDA Review Process," Food and Drug Low Journal 51, no. 4 (1996): 651-676; "Notice - Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program," Federal Register 61 (3 April 1996): 14789; "FDA Annual Report Reveals Good News: New Report Released March 1998; Highlights of Performance for FY 97: Part 5," Biomedical Markt Newsletter (31 March 1998): 1; and "Third-Party Review Pilot May Be Expanded to Include More Class II Devices, FDA's Alpert Says; Review Time Halved for First Two 510(k)s in Pilot," Gray Sheet (16 December 1996): 10.
56. Statement of David Kessler, FDA commissioner, at PDA Reform Legislation Hearings on H.R. 3199, H.R. 3100, and H.R. 3201, House Commerce Subcommittee on Health and Environment, 104th Cong., 2d sess. 84-337 (1996): 27, 28, 34; E. Price, "Teaching the Elephant to Dance: Privatizing the FDA Review Process," Food and Drug Low Journal 51, no. 4 (1996): 651-676; "Notice - Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program," Federal Register 61 (3 April 1996): 14789; "FDA Annual Report Reveals Good News: New Report Released March 1998; Highlights of Performance for FY 97: Part 5," Biomedical Markt Newsletter (31 March 1998): 1; and "Third-Party Review Pilot May Be Expanded to Include More Class II Devices, FDA's Alpert Says; Review Time Halved for First Two 510(k)s in Pilot," Gray Sheet (16 December 1996): 10.
57. Statement of David Kessler, FDA commissioner, at PDA Reform Legislation Hearings on H.R. 3199, H.R. 3100, and H.R. 3201, House Commerce Subcommittee on Health and Environment, 104th Cong., 2d sess. 84-337 (1996): 27, 28, 34; E. Price, "Teaching the Elephant to Dance: Privatizing the FDA Review Process," Food and Drug Low Journal 51, no. 4 (1996): 651-676; "Notice - Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program," Federal Register 61 (3 April 1996): 14789; "FDA Annual Report Reveals Good News: New Report Released March 1998; Highlights of Performance for FY 97: Part 5," Biomedical Markt Newsletter (31 March 1998): 1; and "Third-Party Review Pilot May Be Expanded to Include More Class II Devices, FDA's Alpert Says; Review Time Halved for First Two 510(k)s in Pilot," Gray Sheet (16 December 1996): 10.
58. FDCA Sec. 523(b)(2)(A).
59. Ibid., Sec. 523(a)(1).
60. Ibid., Sec. 523(a)(3)(A).
61. Ibid, Sec. 523(a)(2).
62. Ibid, Sec. 523(b)(3).
63. Ibid., Sec. 523(b)(5), Sec. 523(b)(3)(B), and Sec. 523(b)(3)(E)(v).
64. Ibid, Sec. 523(c).
65. FDAMA, Sec. 210(d)(1).
66. "Agreement of Cooperation between the Canadian Department of National Health and Welfare and the Food and Drug Administration: Exchange of Drug Plant Inspection Information, September 28, 1973," in International Cooperative Agreements Manual (Rockville, Md.: PDA, November 1996), 39-41.
67. "Agreement on Mutual Recognition between the United States of America and the European Community, June 20, 1997" (www.ustr.gov/agreements/ index.html); and "Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; and Pharmaceutical GMP Inspection Reports, Medical Device Quality System Evaluation Reports, and Certain Medical Device Premarket Evaluation Reports," Federal Register 63 (10 April 1998): 17744.
68. "Agreement on Mutual Recognition between the United States of America and the European Community, June 20, 1997" (www.ustr.gov/agreements/ index.html); and "Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; and Pharmaceutical GMP Inspection Reports, Medical Device Quality System Evaluation Reports, and Certain Medical Device Premarket Evaluation Reports," Federal Register 63 (10 April 1998): 17744.
69. FDCA, Sec. 520(f)(1)(B)(iii).
70. Ibid, Sec. 803(c)(1).
71. Ibid, Sec. 803(c)(2).
72. L. Knutson, "Clinton Gives New Powers to FDA in Effort to Speed Drug Approval," Associated Press (24 November 1997); and K. Seelye, "Major Overhaul for FDA as President Signs New Law," New York Times, 22 November 1997, A10.
73. L. Knutson, "Clinton Gives New Powers to FDA in Effort to Speed Drug Approval," Associated Press (24 November 1997); and K. Seelye, "Major Overhaul for FDA as President Signs New Law," New York Times, 22 November 1997, A10.
74. "FDA Modernization Act of 1997," Journal of the American Medical Association 279, no. 5 (1998): 346; and J. Rovner, "U.S. Food and Drug Administration Bill Signed into Law," Lancet (6 December 1997): 1690.
75. "FDA Modernization Act of 1997," Journal of the American Medical Association 279, no. 5 (1998): 346; and J. Rovner, "U.S. Food and Drug Administration Bill Signed into Law," Lancet (6 December 1997): 1690.
76. Washington Legal Foundation v Friedman (1998).
77. P.B. Hutt, "Philosophy of Regulation under the Federal Food, Drug, and Cosmetic Act," Food, Drug, and Cosmetic Law Journal 28, no. 3 (1973): 178; and H. Austern, "Philosophy of Regulation: A Reply to Mr. Hutt," Food, Drug, and Cosmetic Law Journal 28, no. 3 (1973): 191.
78. P.B. Hutt, "Philosophy of Regulation under the Federal Food, Drug, and Cosmetic Act," Food, Drug, and Cosmetic Law Journal 28, no. 3 (1973): 178; and H. Austern, "Philosophy of Regulation: A Reply to Mr. Hutt," Food, Drug, and Cosmetic Law Journal 28, no. 3 (1973): 191.