The regulation of human tissue in the United States: A regulatory and legislative analysis

Food and Drug Law Journal

Volumn 52, Issue 4, 1997, Pages 409-428

  Williams, Marc O ^a  

^a HARVARD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMMUNICABLE DISEASE; DEVICE; DISEASE TRANSMISSION; FOOD AND DRUG ADMINISTRATION; HEALTH CARE FACILITY; LAW; REVIEW; UNITED STATES;

DISEASE TRANSMISSION; HISTORY, 20TH CENTURY; HUMANS; LEGISLATION, MEDICAL; TISSUE BANKS; TISSUE TRANSPLANTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031464844     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (162)

1. Human Tissue Intended for Transplantation, 58 Fed Reg. 65,514 (Dec. 14, 1993).
2. Id.
3. Robin E. Margolis, Should Human Tissue Transplants be Regulated?, HEALTHSPAN, Dec. 1992, at 17.
4. Id.
5. D. Michael Strong, Tissue Banks: Drafting New Rules for Grafting, BUS. & SOC'Y REV., Sept. 22, 1991, available in LEXIS, News Library, ASAPII File.
6. Id.
7. Stuart L. Nightingale, FDA Regulatory Philosophy, 46 FOOD DRUG COSM. L.J. s4, s4-5 (Special Issue 1990). The apparent source for the history provided in this speech was a December 1985 memorandum prepared by an FDA Task Force for the Commissioner, outlining the history of FDA's interest in transplantation. Id. at 8. The author of this article was unable to obtain a copy of this memorandum.
8. Id. at 5.
9. Id. at 6.
10. Strong, supra note 5.
11. See 58 Fed. Reg. at 65,515.
12. Id.
13. Id.
14. Pub. L. No. 98-507, 98 Stat. 2339 (1984).
15. Pub L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
16. Hearing Before the Subcomm. on Investigations and Oversight of the House Comm. on Science and Tech., 98th Cong., 1st Sess. (1983) (statement by FDA concerning its legal authority to regulate human organ transplants and to prohibit their sale), reprinted in PETER B. HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS 693 (2d ed. 1991). Curiously, FDA's statement was not reprinted in the subcommittee's report.
17. Hearing Before the Subcomm. on Investigations and Oversight of the House Comm. on Science and Tech., 98th Cong., 1st Sess. (1983) (statement by FDA concerning its legal authority to regulate human organ transplants and to prohibit their sale), reprinted in PETER B. HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS 693 (2d ed. 1991). Curiously, FDA's statement was not reprinted in the subcommittee's report.
18. Pub. L. No. 94-295, 90 Stat. 539.
19. HUTT & MERRILL, supra note 16, at 694.
20. Ch. 288, 37 Stat. 309 (1912) (codified at42 U.S.C. §§ 201 et seq. (1994)).
21. HUTT & MERRILL, supra note 16, at 695.
22. Id. at 696.
23. Nightingale, supra note 7, at s7.
24. Semen Banking, Organ and Tissue Transplantation, and HIV Antibody Testing, MORTALITY & MORBIDITY WKLY. REP., Feb. 5, 1988, at 57.
25. Nightingale, supra note 7, at s7. The statement was endorsed by the American College of Obstetricians and Gynecologists, the American Fertility Society, and AATB.
26. Id. at s9.
27. See, e.g., Cardiovascular Devices; Effective Date of Requirement for Premarket Approval; Replacement Heart Valve Allograft, 56 Fed. Reg. 29,177 (June 26, 1991); 58 Fed. Reg. 65,514.
28. See, e.g., Cardiovascular Devices; Effective Date of Requirement for Premarket Approval; Replacement Heart Valve Allograft, 56 Fed. Reg. 29,177 (June 26, 1991); 58 Fed. Reg. 65,514.
29. See, e.g., S. 1702, 103d Cong., 1st Sess. (1993); H.R. 1742, 104th Cong., 1st Sess. (1995); S. 1477, 104th Cong., 1st Sess. (1995); H.R. 3199, 104th Cong., 2d Sess. (1996); S. 2195, 104th Cong., 2d Sess. (1996).
30. See, e.g., S. 1702, 103d Cong., 1st Sess. (1993); H.R. 1742, 104th Cong., 1st Sess. (1995); S. 1477, 104th Cong., 1st Sess. (1995); H.R. 3199, 104th Cong., 2d Sess. (1996); S. 2195, 104th Cong., 2d Sess. (1996).
31. See, e.g., S. 1702, 103d Cong., 1st Sess. (1993); H.R. 1742, 104th Cong., 1st Sess. (1995); S. 1477, 104th Cong., 1st Sess. (1995); H.R. 3199, 104th Cong., 2d Sess. (1996); S. 2195, 104th Cong., 2d Sess. (1996).
32. See, e.g., S. 1702, 103d Cong., 1st Sess. (1993); H.R. 1742, 104th Cong., 1st Sess. (1995); S. 1477, 104th Cong., 1st Sess. (1995); H.R. 3199, 104th Cong., 2d Sess. (1996); S. 2195, 104th Cong., 2d Sess. (1996).
33. See, e.g., S. 1702, 103d Cong., 1st Sess. (1993); H.R. 1742, 104th Cong., 1st Sess. (1995); S. 1477, 104th Cong., 1st Sess. (1995); H.R. 3199, 104th Cong., 2d Sess. (1996); S. 2195, 104th Cong., 2d Sess. (1996).
34. Margaret J. Porter, Legal Bases of Tissue and Organ Regulation, 46 FOOD DRUG COSM. L.J. s11, s12 (Special Issue 1990).
35. Id.
36. John Henkel, Safeguarding Human Tissue Transplants, FDA CONSUMER, Sept. 1994, available in LEXIS, News Library, ASAPII File.
37. Id.
38. Tissue Banks Need Tighter Regulation, Panel Told, AIDS WKLY., Oct. 25, 1993, available in LEXIS, Market Library, IACNWS File.
39. Id.
40. Christine Woolsey, Proposals Target Safety of Blood, Tissues, BUS. INS., May 27, 1991, available in LEXIS, Market Library, PROMT File.
41. Strong, supra note 5.
42. Regulation of Human Tissue Banks: Hearing Before the Subcomm. on Regulation, Bus. Opportunities, and Tech. of the House Comm. on Small Bus., 103d Cong., 1st Sess. 32 (1993) (statement of Scott Bottenfeld, LifeNet).
43. Strong, supra note 5.
44. Regulation of Human Tissue Transplantation: Hearings on S. 2908 Before the Senate Comm. on Labor and Human Resources, 102d Cong., 2d Sess. 2 (1992) (statement of Sen. Simon).
45. Regulation of Human Tissue Banks, supra note 36, at 1 (statement of Rep. Wyden).
46. Woolsey, supra note 34.
47. Regulation of Human Tissue Banks, supra note 36, at 2 (statement of Rep. Wyden).
48. Id. at 1. The telefax is reproduced in the record. Id. at 107-10.
49. 58 Fed. Reg. at 65,515.
50. Gordon C. Johnson, Regulating Tissues (and Organs?) as Devices, 46 FOOD DRUG COSM. L.J. s27, s28 (Special Issue 1990).
51. Id. at s30.
52. Id. at s31. See also 58 Fed. Reg. at 65,514.
53. Cardiovascular Devices; Effective Date of Requirement for Premarket Approval; Replacement Heart Valve, 52 Fed. Reg. 18,163 (May 13, 1987) (codified at 21 C.F.R. § 870.395).
54. Id.
55. 56 Fed. Reg. 29,177.
56. Id. at 29,178.
57. Regulation of Human Tissue Transplantation, supra note 38, at 16 (statement of S. Randolph May, National Head of Tissue Servs., American Red Cross).
58. Strong, supra note 5.
59. Id.
60. Regulation of Human Tissue Transplantation, supra note 38, at 16 (statement of S. Randolph May, National Head of Tissue Servs., American Red Cross).
61. Heart Valve Allograft Processors Ask Court to Prohibit FDA Call for PMAs; Non-Profit Tissue Bank Coalition Calls for "Monographs" for Tissue Products, M-D-D-I REP. ("The Gray Sheet"), Oct. 21, 1991, available in LEXIS, EXEC Library, GRAY File.
62. Alabama Tissue Ctr. v. Sullivan, 975 F.2d 373, 378 (7th Cir. 1992).
63. Id.
64. Id. at 379.
65. Heart Valve Allograft Processors Ask Court to Prohibit FDA Call for PMAs, supra note 55.
66. Regulation of Human Tissue Transplantation, supra note 38, at 2 (statement of Sen. Simon).
67. S. 2908, 102d Cong., 2d Sess. § 7(a)-(b); S. 1702 § 7(a)-(b).
68. Cardiovascular Devices; Notice of Agency Decision Not to Enforce Requirement of Premarket Approval; Replacement Heart Valve Allografts, 59 Fed. Reg. 52,078 (Oct. 14, 1994) (codified at 21 C.F.R. § 812).
69. Id.
70. 58 Fed. Reg. at 65,514.
71. Id.
72. Id. at 65,515.
73. Id. at 65,516.
74. Id.
75. 42 U.S.C. § 264.
76. Porter, supra note 28, at s13.
77. Id. at s13-14.
78. 58 Fed. Reg. at 65,516.
79. Id.
80. 21 C.F.R. § 1270. 1(a).
81. Id. § 1270.3(b).
82. Id. § 1270.5(a).
83. Id. § 1270.5(e).
84. Id. § 1270.11.
85. Id. § 1270.13.
86. Id. § 1270.15.
87. Henkel, supra note 30.
88. Id.
89. Osteotech Supports FDA's Interim Rules for Regulation of Human Tissue, PR NEWSWIRE, Dec. 17, 1993, available in LEXIS, Market Library, IACNWS File.
90. FDA Seeking Comments on Tissue Bank Guidelines, TRANSPLANT NEWS, June 30, 1995, available in LEXIS, Market Library, IACNWS File.
91. Id.
92. Biodynamics Wins Right to Ship Allografts, TRANSPLANT NEWS, Apr. 28, 1995, available in LEXIS, Market Library, IACNWS File.
93. Id.
94. Id.
95. Id.
96. Id.
97. Conversation with Kate C. Beardsley, Buc & Beardsley (Jan. 15, 1997).
98. Henkel, supra note 30. See also supra text ac companying note 73.
99. Cathy Clark, No Final Proposed FDA Tissue Regulations Are in Sight, BLOOD WKLY., Sept. 25, 1995, available in LEXIS, Market Library, IACNWS File.
100. Human Tissue Intended for Transplantation, 62 Fed. Reg. 40,429 (July 29, 1997).
101. H.R. 1411, 105th Cong., 1st Sess. (1997).
102. S. 2908 § 6(a).
103. Id. § 355(a).
104. Id. § 355(f)(1)(A).
105. Id. § 355(f)(2).
106. Id. § 355(f)(3).
107. Id. § 355A(a).
108. Id. § 356(a).
109. Id. § 356(a)(2)(F).
110. Id. § 358(b)(1).
111. Id. § 359.
112. Id. § 356(c)(5).
113. Human Tissue, Heart Valve Allografts Should Remain Regulated by FDA - CryoLife, M-D-D-I REP. ("The Gray Sheet"), Aug. 17, 1992, available in LEXIS, EXEC Library, GRAY File.
114. Regulation of Human Tissue Transplantation, supra note 38, at 14 (statement of Randolph May, National Head of Tissue Servs., American Red Cross).
115. Id. at 15.
116. Id.
117. Id. at 16 (statement of Charles Cuono, President, AATB).
118. Id.
119. Id. at 28 (statement of Steven Anderson, President, CryoLife).
120. Id. at 29.
121. Human Tissue, Heart Valve Allografts Should Remain Regulated by FDA - Cryolife, supra note 107.
122. Regulation of Human Tissue Transplantation, supra note 38, at 19 (statement of Jeff Sandler, Exec. Comm. member, NTBC).
123. Id. at 20-21.
124. Representative Wyden introduced a companion bill in the House, H.R. 3547.
125. S. 1702 § 3.
126. Id. § 545(a).
127. Id. § 545(b).
128. Id. § 545(e).
129. Id. § 545(d). The bill did provide for exemptions from the permit requirement in special circumstances.
130. Id. § 546(a).
131. Id. § 546(c).
132. Regulation of Human Tissue Banks, supra note 36, at 9 (statement of Bernard A. Rineberg, President, American Academy of Orthopaedic Surgeons).
133. Id. at 10.
134. Id. at 16 (statement of Stephen Patten, Dir., Oregon Tissue Bank).
135. Id.
136. Id. at 40 (statement of Steven Anderson, President, CryoLife).
137. Id.
138. Id. at 41 (statement of Ted Eastlund, President, AATB).
139. Id. at 42.
140. Id.
141. Id. at 45 (statement of Randolph May, National Head of Tissue Servs., American Red Cross).
142. Id. at 56 (statement of Kathryn C. Zoon, Dir., CBER, FDA).
143. H.R. 1742 § 11(4)(A).
144. Id. § 11(4)(B).
145. S. 1477.
146. S. REP. NO. 104-284, 104th Cong., 2d Sess. 42-43 (1996).
147. Id. at 43.
148. H.R. 3199.
149. Id. § 506(d)(1).
150. Id. § 506(d)(2)(A).
151. Id. § 506(d)(2)(B).
152. Id. § 506(d)(2)(C).
153. S. 2195 § 352A(a)(1).
154. Id. § 352A(b)-(c).
155. Id. § 1(a)(3).
156. Sen. Wyden Introduces Human Tissue Safety Act of 1996, TRANSPLANT NEWS, Oct. 16, 1996, available in LEXIS, Market Library, IACNWS File.
157. H.R. 1411.
158. Id. § 24(a).
159. Id. § 24(b).
160. Id.
161. Id.
162. Id.