FDA Regulation: An Answer to the Questions of Human Cloning and Germline Gene Therapy

American Journal of Law and Medicine

Volumn 27, Issue 1, 2001, Pages 101-124

  Willgoos, Christine ^a  

^a STATE UNIVERSITY OF NEW YORK   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLONING; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; GENETICS AND REPRODUCTION; GERM CELL; HUMAN; LEGAL APPROACH; LEGAL ASPECT; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; GENETICS AND REPRODUCTION; LEGAL APPROACH;

CLONING, ORGANISM; GENE THERAPY; GERM CELLS; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035223039     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (277)

1. See Ian Wilmut et al., Viable Offspring Derived from Fetal and Adult Mammalian Cells, 385 NATURE 810, 812 (1997) (reporting on the birth of lambs from cells established from fetal and adult mammary glands).
2. See David Firn, Roslin Institute Upset By Human Cloning Suggestions, 5 NATURE MEDICINE 253, 253 (1999) (observing that the scientific director of the Roslin Institute "[R]eacted angrily to a January [television] report claiming that the group had turned its back on promises not to clone people").
3. See Memorandum on the Prohibition of Federal Funding for Cloning of Human Beings, WEEKLY COMP. PRES. DOC., at 281, 281 (Mar. 4, 1997) (reporting that no federal funds be used for the cloning of humans).
4. See NATIONAL BIOETHICS ADVISORY COMMISSION, CLONING HUMAN BEINGS - REPORT AND RECOMMENDATIONS OF THE NATIONAL BIOETHICS ADVISORY COMMISSION, June 1997, at 2 ("[A]ddressing a very specific aspect of [human cloning], namely where genetic material would be transferred from the nucleus of a somatic cell of an existing human being to an enucleated human egg with the intention of creating a child.") [hereinafter CLONING HUMAN BEINGS].
5. See NATIONAL BIOETHICS ADVISORY COMMISSION, CLONING HUMAN BEINGS - REPORT AND RECOMMENDATIONS OF THE NATIONAL BIOETHICS ADVISORY COMMISSION, June 1997, at 2 ("[A]ddressing a very specific aspect of [human cloning], namely where genetic material would be transferred from the nucleus of a somatic cell of an existing human being to an enucleated human egg with the intention of creating a child.") [hereinafter CLONING HUMAN BEINGS].
6. 5 See discussion infra Part V.B.2. and accompanying notes.
7. See discussion infra Part III. and accompanying notes.
8. See Steve Mirsky & John Rennie, What Cloning Means for Gene Therapy, 276 SCIENTIFIC AMERICAN, 122, 123 (1997) (noting that researchers and the general public are concerned about the potential for misapplication of gene therapy "toward eugenic goals"). See also Paul R. Billings et al., Human Germline Gene Modification: A Dissent, 353 THE LANCET 1873, 1874 (1999) (asserting that germline intervention is an individual or familial form of eugenics).
9. See Steve Mirsky & John Rennie, What Cloning Means for Gene Therapy, 276 SCIENTIFIC AMERICAN, 122, 123 (1997) (noting that researchers and the general public are concerned about the potential for misapplication of gene therapy "toward eugenic goals"). See also Paul R. Billings et al., Human Germline Gene Modification: A Dissent, 353 THE LANCET 1873, 1874 (1999) (asserting that germline intervention is an individual or familial form of eugenics).
10. See CLONING HUMAN BEINGS, supra note 4, at 95 (noting the Commission's view that in addition to human cloning being "morally unacceptable," there is abundant evidence that cloning is also unsafe in its current form).
11. See generally Kathryn D. Katz, The Clonal Child: Procreative Liberty and Asexual Reproduction, 8 ALB. L.J. SCI. & TECH. 1, 15-23 (1997) (discussing common misconceptions regarding human cloning).
12. See Gina Kolata, Congress is Cautioned Against Ban on Human-Cloning Work, N.Y. TIMES, Mar. 13, 1997, at B11.
13. See id.
14. See Robert P. Lanza et al., Human Therapeutic Cloning, 5 NATURE MEDICINE 975, 975 (1999) (discussing the potential uses for human therapeutic cloning).
15. See, e.g., H.R. 571, 106th Cong. (1999); H.R. 2326, 106th Cong. (1999).
16. See Katz, supra note 9, at 3 (discussing human cloning as a means to create individuals who are genetically identical to existing or deceased persons).
17. See Lanza et al., supra note 12, at 975 (discussing the possible uses of therapeutic cloning).
18. The term "cloning" is used in other contexts to refer to the replication of a single cell to create a colony. See BRUCE ALBERTS ET AL., MOLECULAR BIOLOGY OF THE CELL 162 (2d ed. 1989). It is also used to describe the replication of segments of DNA. See id. at 181. For the purposes of this Note and unless otherwise indicated, "cloning" refers specifically to somatic cell nuclear transfer techniques.
19. A somatic cell is a differentiated cell of the body, which, in contrast to a germ cell, is not capable of reproducing the organism. See ELDON JOHN GARDNER ET AL., PRINCIPLES OF GENETICS G11 (8th ed. 1991).
20. A pluripotent stem cell is an active somatic cell capable of giving rise to most, but not all, tissues of an organism. See National Institutes of Health, Stem Cells: A Primer (May 2000) (visited Mar. 15, 2001) 〈http://www.nih.gov/news/stemcell/primer.htm〉. A totipotent stem cell is an active somatic cell with an unlimited capacity to specialize into membranes, tissues and organs, including the capability of developing into an embryo. See id.
21. See CLONING HUMAN BEINGS, supra note 4, at 28 (noting that "in order for a differentiated nucleus to redirect development in [the egg], its constellation of regulatory proteins must be replaced by those of the egg in time for the embryo to use the donor nucleus to direct normal development of the embryo"). No attempt was made by Wilmut et al. to determine if the transferred nucleus that created Dolly was derived from a fully differentiated cell or a pluripotent stem cell. See id. Since pluripotent cells are not fully differentiated, the potential of differentiated cells to be reprogrammed to create an embryo was unconfirmed. See id. However, subsequent experiments by Wakayama et al. produced clonal mice from differentiated granulosa cells. See Davor Solter, Dolly Is a Clone - and No Longer Alone, 394 NATURE 315, 315 (1998) (describing techniques used in cloning mice).
22. See CLONING HUMAN BEINGS, supra note 4, at 28 (noting that "in order for a differentiated nucleus to redirect development in [the egg], its constellation of regulatory proteins must be replaced by those of the egg in time for the embryo to use the donor nucleus to direct normal development of the embryo"). No attempt was made by Wilmut et al. to determine if the transferred nucleus that created Dolly was derived from a fully differentiated cell or a pluripotent stem cell. See id. Since pluripotent cells are not fully differentiated, the potential of differentiated cells to be reprogrammed to create an embryo was unconfirmed. See id. However, subsequent experiments by Wakayama et al. produced clonal mice from differentiated granulosa cells. See Davor Solter, Dolly Is a Clone - and No Longer Alone, 394 NATURE 315, 315 (1998) (describing techniques used in cloning mice).
23. See, e.g., Wilmut et al., supra note 1, at 812-13; T. Wakayama et al., Full-term Development of Mice From Enucleated Oocytes Injected with Cumulus Cell Nuclei, 394 NATURE 369, 373 (1998) (discussing various methods of nuclear transfer).
24. See, e.g., Wilmut et al., supra note 1, at 812-13; T. Wakayama et al., Full-term Development of Mice From Enucleated Oocytes Injected with Cumulus Cell Nuclei, 394 NATURE 369, 373 (1998) (discussing various methods of nuclear transfer).
25. See Mirsky & Rennie, supra note 7, at 122.
26. Although generally considered a genetic twin, the cloned individual may not have the identical genetic makeup of the donor. See Hessel Bouma, Ethical Considerations in Human Cloning, 125 SURGERY 468, 468 (1999). A small segment of DNA (0.05%) is extra-nuclear, mitochondrial DNA ("mtDNA"). See id. mtDNA is not inherited from the nuclear donor, but is transferred to progeny from the cytoplasm of the egg cell. See id. Therefore, the clone will have different mtDNA from the nuclear donor, unless the nuclear donor is also the egg donor. See id.
27. See CLONING HUMAN BEINGS, supra note 4, at 95.
28. The scientists who created Dolly the sheep had a success rate of one surviving sheep out of 277 nuclear transfers. See CLONING HUMAN BEINGS, supra note 4, at 24. Wakayama et al. reports 10 surviving mice out of 800 embryos transferred, and five surviving mice out of 298 embryos transferred in a subsequent experiment. See Wakayama et al., supra note 20, at 371.
29. See Paul Shiels et al., Analysis of Telomere Lengths in Cloned Sheep, 399 NATURE 316, 317 (1999) (finding a significant difference between the cells from cloned animals and those of age-matched control animals). Cf. Nicholas Wade, Experimentation on Cow's Cells Offers More Hope for Cloning, N.Y. TIMES, Apr. 28, 2000, at A18 (reporting that cloned cows had normal telomere lengths and, therefore, should live at least as long as cows not produced through cloning).
30. See Paul Shiels et al., Analysis of Telomere Lengths in Cloned Sheep, 399 NATURE 316, 317 (1999) (finding a significant difference between the cells from cloned animals and those of age- matched control animals). Cf. Nicholas Wade, Experimentation on Cow's Cells Offers More Hope for Cloning, N.Y. TIMES, Apr. 28, 2000, at A18 (reporting that cloned cows had normal telomere lengths and, therefore, should live at least as long as cows not produced through cloning).
31. See J.A. Morris, Effects of Somatic Cloning, 354 THE LANCET 255, 255 (1999) (arguing that cloning will lead to an increased chance of impaired development, impaired function and polygenic disease).
32. For reports of cloned sheep, see Wilmut et al., supra note 1. For a report on mice, see Wakayama et al., supra note 20, at 371. See also Yoko Kato et al., Eight Calves Cloned from Somatic Cells of a Single Adult, 282 SCIENCE 2095, 2095 (1998) (reporting on the ability to successfully clone calves). Notably, South Korean researchers have reported the creation of a human embryo to the four cell stage. See Jonathan Watts & Kelly Morris, Human Cloning Trial Met with Outrage and Scepticism, 353 THE LANCET 43, 43 (1999) (discussing the validity and probability of cloning a human to the four cell stage). However, this report is undocumented and its validity has been questioned by the scientific community. See id.
33. For reports of cloned sheep, see Wilmut et al., supra note 1. For a report on mice, see Wakayama et al., supra note 20, at 371. See also Yoko Kato et al., Eight Calves Cloned from Somatic Cells of a Single Adult, 282 SCIENCE 2095, 2095 (1998) (reporting on the ability to successfully clone calves). Notably, South Korean researchers have reported the creation of a human embryo to the four cell stage. See Jonathan Watts & Kelly Morris, Human Cloning Trial Met with Outrage and Scepticism, 353 THE LANCET 43, 43 (1999) (discussing the validity and probability of cloning a human to the four cell stage). However, this report is undocumented and its validity has been questioned by the scientific community. See id.
34. For reports of cloned sheep, see Wilmut et al., supra note 1. For a report on mice, see Wakayama et al., supra note 20, at 371. See also Yoko Kato et al., Eight Calves Cloned from Somatic Cells of a Single Adult, 282 SCIENCE 2095, 2095 (1998) (reporting on the ability to successfully clone calves). Notably, South Korean researchers have reported the creation of a human embryo to the four cell stage. See Jonathan Watts & Kelly Morris, Human Cloning Trial Met with Outrage and Scepticism, 353 THE LANCET 43, 43 (1999) (discussing the validity and probability of cloning a human to the four cell stage). However, this report is undocumented and its validity has been questioned by the scientific community. See id.
35. 28 See supra text accompanying note 24; see also Kato, supra note 27, at 2097.
36. See Perils in Free Market Genomics, 392 NATURE 315, 315 (1998) (arguing that the ethical, as well as scientific, problems involved with modifying the human germline should be assessed before taking definitive steps in any direction).
37. See id.
38. See Rick Weiss, Embryo Work Raises Specter Of Human Harvesting; Medical Research Teams Draw Closer to Cloning, WASH. POST, June 14, 1999, at A1. The creation of human embryos for research purposes is prohibited for researchers funded by the federal government, but is allowed in the private sector subject to state law. See id.
39. See id.
40. See id.
41. See Ethics Committee Report, Human Somatic Cell Nuclear Transfer (Cloning), FERTILITY & STERILITY, Nov. 2000, at 873, 873 (stating that "improvements in animal cloning indicate that safety concerns may be only a temporary barrier to reproductive [cloning] in humans").
42. See Dorothy C. Wertz, Germline Gene Therapy: Is it Almost Here?, THE GENE LETTER (Mar. 1997) (visited Mar. 19, 2001) 〈http://www.geneletter.com/archives/germlinetherapy.html〉.
43. Although some recessive genetic disorders are caused by a single gene, most genetic characteristics are polygenic, that is, they are caused by a complex interaction of several genes and gene products. See LeRoy Walters, The Ethics of Human Gene Therapy, 320 NATURE 225, 225 (1986). However, in light of many unknowns involved in genetic therapy, the best candidates for germline gene therapy are considered to be those disorders caused by a single gene. See id.
44. See id.
45. See Mirsky & Rennie, supra note 7, at 122.
46. See Walters, supra note 36, at 227. Germline gene therapy may be effective by simply introducing a healthy gene into the embryo. See Mirsky & Rennie, supra note 7, at 122. In order, however, to prevent transmission of the malfunctioning gene to future generations, gene inactivation or replacement should be used. See Walters, supra note 36, at 227.
47. A vector is a biological vehicle used to introduce recombinant DNA into living cells. See GARDNER ET AL., supra note 17, at G12.
48. See Mirsky & Rennie, supra note 7, at 123.
49. See id.
50. See Meredith Wadman, Germline Gene Therapy 'Must Be Spared Excessive Regulation', 392 NATURE 317, 317 (1998) (reporting that most experts on the panel of a symposium called "Engineering the Human Germ Line" stressed that germline gene therapy must be preceded by work in animal and human cell lines before attempting therapy in human embryos).
51. See id.
52. The Human Genome Project is a worldwide effort aimed at identifying and sequencing every human gene in the hope of "decoding" the genome and applying the knowledge to scientific and medical advancement. See Human Genome Project Information (last modified Dec. 22, 2000) 〈http://www.ornl.gov/hgmis/project/about.html〉.
53. See id. (stating that knowledge of the human genome can lead to new ways to diagnose, treat and prevent thousands of disorders affecting humans).
54. See Wadman, supra note 43, at 317. The DNA chip is a small, electronic device made of glass or plastic that is similar to a computer chip but contains short segments of DNA and can be used to detect the genetic characteristics of blood or fluid samples. See Paul Jacobs, Not Feeling Well? The Microchip Will See You Now, L.A. TIMES, Nov. 29, 1999, at C1. The chip has the ability to test for hundreds of genes at a time. See id. at C7. It is predicted that the DNA chip will eventually replace cumbersome, more traditional methods for diagnosing disease. See id.
55. A gamete is a mature reproductive cell; an egg or a sperm cell. See GARDNER ET AL., supra note 17, at G5.
56. See Mirsky & Rennie, supra note 7, at 122-23. See also discussion infra Part IV.A. and accompanying notes.
57. See id.
58. See id. Because early stage embryonic stem cells lose their pluripotent capacity after only a few cell divisions, the number of cells gene therapists have to work with is limited. See id. Cloning can increase the number of embryonic cells available and thereby increase the efficiency of germline gene therapy. See id.
59. This process would not actually transfer a somatic cell of an adult. See id. Rather, a sexually produced early cell stage embryonic cell nucleus would be transferred to an egg cell which has not yet lost its totipotent capacity. See id.
60. See id.
61. See CLONING HUMAN BEINGS, supra note 4, at chs. 3, 4 (discussing how cloning entails potential known and unknown risks and violates human dignity by jeopardizing the personal and unique identity of the clone).
62. See, e.g., CLONING HUMAN BEINGS, supra note 4, at ch. 3 ("Religious Perspectives") & ch. 4 ("Ethical Considerations") (asserting that the human embryo, because of its potential to develop into human life, is considered by American society and law as deserving of more respect than other bodily tissues). This belief is reflected in federal regulations against funding embryo creation for research purposes. See discussion infra Part V.A. and accompanying notes.
63. While some of these arguments will be discussed in this Note, see infra Part IV., for a more comprehensive review of these arguments, see CLONING HUMAN BEINGS, supra note 4, at chs. 3, 4 (explaining that arguments against cloning and germline gene therapy stem from moral, ethical, societal and religious values).
64. See, e.g., Robert Wilson, Note, Environmental Regulation of the Human Gene Pool as a Genetic Commons, 5 N.Y.U. ENVTL. L.J. 833, 846 (1996).
65. See id. The theory of natural selection teaches that nature favors individuals that are better adapted to their environment, thereby eliminating less fit organisms from the gene pool. See GARDNER ET AL., supra note 17, at G8.
66. Since cloning is a form of asexual reproduction, the mutations of the genetic donor will be present in the genome of a clonal individual. See Morris, supra note 26, at 255. By contrast, sexual reproduction involves recombination of genes, thereby preventing a rise in the number of harmful mutations in the genome of the offspring. See id.
67. See discussion supra note 39.
68. See GARDNER ET AL., supra note 17, at 581.
69. In order to be affected with the sickle cell disease, an individual must carry two copies of the affected gene (the individual is said to be homozygous for the trait). See id. at 580. Yet, a heterozygous carrier of the trait (an individual who carries one copy of the disease gene and one normal copy) has a greater resistance to malaria than does a homozygous, non-affected individual. See id. at 581. Therefore, the heterozygous individual is more fit and has a selective advantage over both homozygous conditions. See id. Sickle cell anemia is one target for germline gene therapy because it is a monogenic trait. See Mirsky & Rennie, supra note 7, at 123. Germline gene therapy has the potential to reduce or eradicate the sickle cell gene. See id. This eliminates the selective advantage conferred by the heterozygous occurrence of the gene.
70. See Morris, supra note 26, at 255 (asserting that the integrity of the genome is maintained by strong selective pressure that acts against harmful mutations, not against single harmful mutations which, if targeted individually, could result in the extinction of the human race).
71. See Katz, supra note 9, at 17 (suggesting that some people fear that clonal beings will be viewed as less than human and will, therefore, be subject to abuse and exploitation).
72. See Lori B. Andrews, Is There a Right to Clone? Constitutional Challenges to Bans on Human Cloning, 11 HARV. L.J. 643, 668 (1998) (arguing that human cloning may be a form of "genetic bondage" that violates the Thirteenth Amendment prohibition against slavery).
73. See Julian Savulescu, Should We Clone Human Beings? Cloning as a Source of Tissue for Transplantation, 25 J. MED. ETHICS 87, 91 (1999) (arguing that it is both morally permissible and morally required to use cloning to produce embryos and fetuses for the purpose of providing cells, tissues and organs for therapy, and then aborting the embryo or fetus).
74. See Katz, supra note 9, at 17 (discussing the fear that clones will be viewed as less than human).
75. See CLONING HUMAN BEINGS, supra note 4, at 50-51.
76. See Vernon J. Ehlers, The Case Against Human Cloning, 27 HOFSTRA L. REV. 523, 526-27 (1999).
77. See id.
78. See discussion infra Part III.C. and accompanying notes (discussing that although society may try to create a "superior" human race by eliminating "undesirable" traits, people are products of their environment, not just their genes).
79. See id.
80. See Andrews, supra note 65, at 653-57 (arguing that a cloned child may seem more like an object than a person).
81. See id. at 655-56.
82. See id.
83. See id.
84. See Dorothy C. Wertz, Twenty-one Arguments Against Human Cloning, and Their Responses, THE GENE LETTER (Aug. 1998) (visited Mar. 15, 2001) 〈http://www.geneletter.com/archives/twentyone arguments.html〉 (rebutting common arguments against cloning humans, but also arguing the unpredictability of psychological impacts on cloned children remains the strongest argument against cloning).
85. See id. (stating that there is no reason to prejudge potential families with cloned children).
86. See id.
87. See John A. Robertson, Two Models of Human Cloning, 27 HOFSTRA L. REV 609, 624 (1999) (asserting that although raising a clone may pose special problems, couples who proceed with cloning after counseling and preparation for such problems will likely be competent and loving parents devoted to their child's unique identity and welfare).
88. See, e.g., Wadman, supra note 43, at 317.
89. See Perils in Free Market Genomics, supra note 29, at 315. See also Lori B. Andrews, The Current and Future Legal Status of Cloning, commissioned for CLONING HUMAN BEINGS, supra note 4, at F3 (arguing that cloning could permanently damage DNA and thereby cause mutations leading to various cancers).
90. See Perils in Free Market Genomics, supra note 29, at 315. See also Lori B. Andrews, The Current and Future Legal Status of Cloning, commissioned for CLONING HUMAN BEINGS, supra note 4, at F3 (arguing that cloning could permanently damage DNA and thereby cause mutations leading to various cancers).
91. See Perils in Free Market Genomics, supra note 29, at 315.
92. See Morris, supra note 26, at 255.
93. See CLONING HUMAN BEINGS, supra note 4, at 29; see also discussion supra Part III.A.1.
94. See CLONING HUMAN BEINGS, supra note 4, at 29; see also discussion supra Part III.A.1.
95. See CLONING HUMAN BEINGS, supra note 4, at 29.
96. See Morris, supra note 26, at 255.
97. See discussion supra note 59.
98. See Morris, supra note 26, at 255 (arguing that cloning will lead to an increased chance of impaired development, impaired function and polygenic disease).
99. See CLONING HUMAN BEINGS, supra note 4, at 29 (discussing that mutations in genes can predispose a cell to become cancerous).
100. See Morris, supra note 26, at 255.
101. See Caroline Daniel, We're a Long Way From Designer Babies, in CLONING FOR AND AGAINST at 36, 37 (M.L. Rantala & Arthur J. Miligram eds. 1999) (discussing the problems involved in gene therapy).
102. See Walters, supra note 36, at 225.
103. See id.
104. See id.
105. See Daniel, supra note 92, at 37.
106. See David Firn, Deal Creates Lead Cloning Company, 5 NATURE MEDICINE 595, 595 (1999) (reporting that a merger between two biotechnology companies has lead to speculation that the enzyme telomerase, which extends the replicative life of cells, will now be studied in conjunction with cloning).
107. See generally CLONING HUMAN BEINGS, supra note 4 (discussing the fears, concerns and moral reservations about the potential abuse of the new technology).
108. See Paula Campbell et al., Symposium: Gene Therapy: Legal, Financial and Ethical Issues, 4 B.U. J. SCI. & TECH. L. 3, ¶ 60 (1998) (comments of Leonard H. Glantz) (arguing that there is a consensus that cloning and germline gene therapy should not be practiced to achieve "made to order" individuals).
109. See Andrews, supra note 65, at 653.
110. See CLONING HUMAN BEINGS, supra note 4, at 36 (arguing that there is a general erroneous belief that a person's genes bear a simple relationship to the traits that compose the individual).
111. See id., supra note 4, at 36-38 (discussing genetic determinism).
112. See Dan W. Brock, An Assessment of the Ethical Issues Pro and Con, commissioned for CLONING HUMAN BEINGS, supra note 4, at E9-E10 (arguing that individuals are not shaped solely by their genes).
113. See id. at E12 (arguing that sharing an identical genome does not prevent twins from developing distinct personal identities).
114. 105 See id. (noting that among other distinctions, differences in life histories can play an integral role in the unique and individual development of two genetically identical individuals).
115. See id. at E9-E10 (arguing that although Mozart's and Einstein's extraordinary capabilities were partly determined by genetics, they were also influenced by their environments and experiences).
116. See id. There is, of course, the additional question of who and what determines which traits are superior. See id. In addition, creation of clones will likely be limited by the availability of societal and economic resources. See Wertz, supra note 77.
117. See Walters, supra note 36, at 225 (stating that the first attempts at germline gene therapy will be for monogenic disorders).
118. See GARDNER ET AL., supra note 17, at 248.
119. See Brock, supra note 103, at E9-E10.
120. See id.
121. See id.
122. See, e.g., id. at E20 (asserting that sexual forms of reproduction will remain the norm).
123. See Mirsky & Rennie, supra note 7, at 123.
124. See Lanza, supra note 12, at 975 (discussing how new techniques may soon be used to clone genetically matched cells and tissues for transplantation into patients suffering from a wide range of disorders).
125. See id.
126. See June Coleman, Playing God or Playing Scientist: A Constitutional Analysis of State Laws Banning Embryological Procedures, 27 PACIFIC L.J. 1331, 1353-60 (1996).
127. See id.
128. See Robertson, supra note 80, at 621-22.
129. See id.
130. Basic Mendelian genetics teaches that a monohybrid cross of two heterozygotes will result in one fourth of the offspring containing the homozygous recessive trait, one half containing the heterozygous genotype, and one fourth containing the homozygous dominant genes. See GARDNER ET AL., supra note 17, at 22-26. Therefore, three-fourths of the children produced through the union will have at least one copy of the affected gene.
131. See Mirsky & Rennie, supra note 7, at 122.
132. See id. at 122-23 (explaining how germline gene therapy could create a healthy embryo through cloning techniques).
133. See Robertson, supra note 80, at 622.
134. See id.
135. See id.
136. In vitro fertilization is the fertilization of a mature egg cell which occurs outside of the body. See CLONING HUMAN BEINGS, supra note 4, at appendix A.
137. See Mirsky & Rennie, supra note 7, at 123.
138. See discussion supra Part II.B. and accompanying notes.
139. This can be done by using in vitro techniques to fertilize her egg, then transferring the resulting nucleus via cloning techniques to a donor egg with unaffected mitochondria, and implanting the resulting embryo into her uterus. See Bouma, supra note 22, at 468.
140. See Lanza supra note 12, at 975. Differentiation is the process by which unspecialized cells develop the structural and functional characteristics of a particular organ or tissue. See GARDNER ET AL., supra note 17, at G4.
141. See supra text accompanying note 19.
142. See CLONING HUMAN BEINGS, supra note 4, at 33-34.
143. See id.
144. See Lanza, supra note 12, at 976-77.
145. See id.
146. See ABBAS ET AL., CELLULAR AND MOLECULAR IMMUNOLOGY 347 (1994).
147. See Weiss, supra note 31, at A1.
148. See generally Weiss, supra note 31 (stating that current research focuses on the potential to harvest organs through cloning human embryos in order to circumvent the problems associated with immunorejection of donated organs).
149. The Department of Health and Human Services and the National Institutes of Health have determined that a pluripotent stem cell is not a human embryo as defined by statute and, therefore, that pluripotent stem cell research may be federally funded. See HHS Fact Sheet: Stem Cell Research (Jan. 19, 1999), available at http://www.hhs.gov/news/press/1999pres/990119.html. In contrast, human cloning techniques create a totipotent embryonic stem cell and cannot receive federal funding for research. See CLONING HUMAN BEINGS, supra note 4, at 29. However, because of the less differentiated state of the cell and the ability to make identical cells, cells made through cloning techniques are generally considered superior for the purpose of cell differentiation research. See id. at 30.
150. The Department of Health and Human Services and the National Institutes of Health have determined that a pluripotent stem cell is not a human embryo as defined by statute and, therefore, that pluripotent stem cell research may be federally funded. See HHS Fact Sheet: Stem Cell Research (Jan. 19, 1999), available at http://www.hhs.gov/news/press/1999pres/990119.html. In contrast, human cloning techniques create a totipotent embryonic stem cell and cannot receive federal funding for research. See CLONING HUMAN BEINGS, supra note 4, at 29. However, because of the less differentiated state of the cell and the ability to make identical cells, cells made through cloning techniques are generally considered superior for the purpose of cell differentiation research. See id. at 30.
151. See CLONING HUMAN BEINGS, supra note 4, at 38.
152. See Firn, supra note 97, at 595 (reporting efforts to reprogram human cells without using eggs or creating embryos).
153. See Pub. L. 106-113 § 510 (1999).
154. See National Institutes of Health, Notice of Legislation Mandates Contained in the FY2000 Omnibus Appropriations P.L. 106-113 (visited Jan. 6, 2000) 〈http://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-00-010. html〉. NIH guidelines state that grant, cooperative agreement and contract funds may not be used for the creation of human embryos for research purposes. See id. "Human embryo" is defined by the NIH "as any organism . . . that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells." Id.
155. See id. The NIH is not permitted to fund "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero." Id.
156. See National Institutes of Health, Directive on Human Embryo Research (visited Mar. 11, 2001) 〈http://www.grants.nih.gov/grants/policy/humanembryo.html〉.
157. See generally Andrews, supra note 82.
158. See id. at F18-F22 (outlining several state statutes dealing with whether and to what extent germline gene therapy on humans is permissible and observing a key distinction drawn between therapeutic and experimental uses).
159. See Biotechnology Industry Organization, Gene Therapy (visited Feb. 27, 2000) 〈http://www.bio.org/bioethics/genetherapy.html〉 (stating that this moratorium has been in place for over ten years).
160. See Memorandum on the Prohibition of Federal Funding for Cloning of Human Beings, supra note 3, at 281.
161. See Letter From President Bill Clinton to Dr. Harold Shapiro, Chair, National Bioethics Advisory Commission (Feb. 24, 1997), in CLONING HUMAN BEINGS, supra note 4, at 3-4.
162. See CLONING HUMAN BEINGS, supra note 4, at 95-96.
163. See id. at 96.
164. See id.
165. See, e.g., Andrews, supra note 82, at F5-F7 (discussing the reach of the Commerce Clause, the right to scientific inquiry and the right to make reproductive decisions). See also, Valerie S. Rup, Note, Human Somatic Cell Nuclear Transfer Cloning, The Race to Regulate, and the Constitutionality of the Proposed Regulations, 76 U. DET. MERCY L. REV. 1135, 1151-52 (1999) (discussing lower court decisions that have interpreted the Supreme Court abortion cases to prohibit the state from interfering with a person's reproductive choices prior to fetal viability, but noting the Supreme Court's unwillingness to expand privacy rights).
166. See Andrews, supra note 65, at 661-69.
167. See Eisenstadt v. Baird, 405 U.S. 438, 453 (1972) (stating that "if the right of privacy means anything, it is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child").
168. See id.
169. See Roe v. Wade, 410 U.S. 113, 155 (1973) (holding that the decision to have an abortion, though limited in some circumstances, is covered by the right to privacy).
170. See Coleman, supra note 117, at 1363-64 (deriving a constitutionally protected right to make decisions concerning childbearing as the "underlying foundation" of several Supreme Court decisions).
171. See Katz, supra note 9, at 39 (arguing that the right not to procreate is more clearly protected by the Supreme Court than the right to procreate).
172. See Anne Lawton, The Frankenstein Controversy: The Constitutionality of a Federal Ban on Cloning, 87 KY. L.J. 277, 334 (1998-99) (arguing that a right to cloning will not likely be recognized as a fundamental right based on prior jurisprudence).
173. See Lifchez v. Hartigan, 735 F. Supp. 1361, 1377 (N.D. Ill. 1990), aff'd mem., 914 F.2d 260 (7th Cir. 1990).
174. See id. at 1377.
175. See generally Andrews, supra note 65, at 661-64 (presenting a review of lower court and Supreme Court decisions which indicate that a right to scientific inquiry may be protected by the First Amendment, but is not absolute).
176. See id. at 662.
177. See id. at 663.
178. See id.
179. See U.S. CONST. art. I, § 8, cl. 3.
180. See Andrews, supra note 65, at 669.
181. See Wickard v. Filburn, 317 U.S. 111, 125 (1942) (discussing when an activity can be reached by Congress).
182. See Andrews, supra note 65, at 670-75 (discussing Supreme Court decisions which have upheld federal legislation as proper under the Commerce Clause).
183. See id. at 672-73.
184. See Andrews, supra note 82, at F34-F35.
185. See Andrews, supra note 65, at 673.
186. See S. 368, 105th Cong. (1997); H.R. 922, 105th Cong. (1997); H.R. 923, 105th Cong. (1997).
187. See CLONING HUMAN BEINGS, supra note 4, at Table 1 (providing a list of proposed legislation pertaining to the cloning of human beings which includes S. 368, H.R. 922, and H.R. 923).
188. The bill defines cloning as "the replication of a human individual by the taking of a cell with genetic material and the cultivation of the cell through the egg, embryo, fetal, and newborn stages into a new human individual" (emphasis added). S. 368, 105th Cong. (1997). This language prohibits the "birth" of a cloned individual, but arguably does not apply to the intermediate stages of development, so that the creation and gestation of a fetus terminated before viability may not fall within the statutory prohibition.
189. See H.R. 922, 105th Cong. (1997); H.R. 923, 105th Cong. (1997).
190. A somatic cell is generally considered a fully differentiated cell of the body. See GARDNER ET AL., supra note 17, at G11. However, it is possible to perform a somatic cell nuclear transfer with a less differentiated cell, for example, a pluripotent stem cell. See, e.g., Wilmut, supra note 1, at 810. Therefore, the language of the Elhers bills may not encompass all possible means of cloning. Similarly, the Bond bill includes only the creation of a viable child. See supra note 178 and accompanying text (explaining that the creation of a child arguably would not fall within the statutory prohibition).
191. See S. 1574, 105th Cong. (1998) ("It shall be unlawful for any person to (a) clone a human being; or (b) conduct research for the purpose of cloning a human being or otherwise creating a human embryo.").
192. See S. 1599, 105th Cong. (1998) ("It shall be unlawful for any person . . . to use human somatic cell nuclear transfer technology.").
193. See S. 1601, 105th Cong. (1998) ("It shall be unlawful for any person . . . to use human somatic cell nuclear transfer technology.").
194. The Lott and Bond bills do not define "somatic cell," so, conceivably, a pluripotent stem cell could be used without violating the proposed statute. See supra note 179 and accompanying text (explaining that Elhers' bill does not define somatic cell or human clone). The Campbell bill defines cloning as "transferring the nucleus from a human cell . . . into a human egg cell." See S. 1574, 105th Cong. (1998). However, it has been shown that a human nucleus can be implanted into a cow embryo and successfully undergo cell division. See Wade, supra note 25, at A18. Therefore, the Campbell bill does not prohibit all forms of cloning research.
195. The bill introduced by Senator Feinstein (D-CA) proposed to amend the Public Health Services Act to "prohibit any attempt . . . to clone a human being, that is, to use the product of somatic cell nuclear transfer to create a human being genetically identical to an existing or deceased human being . . . . Nothing in this section shall be construed to restrict . . . practices not expressly prohibited in this section, including research . . . of somatic cell nuclear transfer of other cloning technologies to clone molecules, DNA, cells, and tissues." S. 1602, 105th Cong. (1998). Similarly, the bill proposed by Representative Stearns (R-FL) aims to protect "scientific research not specifically prohibited by this Act, including . . . the use of somatic cell nuclear transfer or other cloning technologies to clone molecules, DNA, cells other than human embryo cells, or tissues." H.R. 3133, 105th Cong. (1998).
196. Arguably, the term "genetically identical" creates a loophole in the Feinstein bill, because, as discussed supra note 22, if the nuclear donor and the egg donor are not the same person, the resulting embryo will contain different mitochondrial DNA from the nuclear donor, and, therefore, will not be genetically identical. In addition, as seen in other bills, "somatic cell" is defined only to include differentiated cells, creating the possibility of cloning from a pluripotent stem cell. See discussion supra note 180. The Stearns bill applies only to federal funding, and does not prohibit private sector use of cloning technology. See H.R. 3133, 105th Cong. (1998). The bill attempts to protect federal funding of scientific research, for example, by limiting the reach of the prohibition to "the use of somatic cell nuclear transfer . . . to clone . . . cells other than human embryo cells." H.R. 3133, 105th Cong. (1998). Yet, the bill does not define "human embryo cells." See id.
197. See H.R. 571, 106th Cong. (1999); H.R. 2326, 106th Cong. (1999).
198. "None of the funds made available in any Federal law may be obligated or expended to conduct or support any project of research that includes the use of human somatic cell nuclear transfer technology to produce an oocyte that is undergoing cell division toward the development of a fetus." H.R. 2326, 106th Cong. (1999).
199. "Nothing in this Act shall restrict other areas of scientific research . . . including . . . work that involves . . . cells other than human embryo cells." H.R. 2326, 106th Cong. (1999).
200. The bill fails to define "human embryo." See id. In addition, the language "undergoing cell division toward the development of a fetus" arguably restricts funding of any somatic cell nuclear transfer product that undergoes cell division. See id.
201. See H.R. 571, 106th Cong. (1999). The bill defines human cloning as "making an identical, or substantially identical, copy of the genetic material of an individual human being, living or deceased, so as to cultivate one or more new human cells which could, if not otherwise engineered, develop into a new individual human being." Id. Therefore, the bill explicitly prohibits federal funding of cloning research not intended to create a child.
202. A human embryo is defined by the NIH as "any organism . . . that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells." See National Institutes of Health, supra note 144.
203. See discussion supra Part V.A. and accompanying notes.
204. See Perils in Free Market Genomics, supra note 29, at 315.
205. See Paul Berg & Maxine Singer, Regulating Human Cloning, 282 SCIENCE 413, 413 (1998) (arguing that legislation is not the best tool for regulating scientific development).
206. See Andrews, supra note 82, at F31.
207. See Lori B. Andrews, We Need Regulation of Reproduction, in CLONING FOR AND AGAINST, supra note 92, at 178, 181, 184 (advocating governmental oversight of reproductive technologies).
208. See Andrea L. Bonnicksen, The Politics of Germline Therapy, 19 NATURE GENETICS 10, 11 (1998) (arguing that public discussion of scientific advancement is necessary to help guide research).
209. See id. at 10.
210. Id. at 11.
211. See Coleman, supra note 117, at 1349-52.
212. See Andrews, supra note 65, at 660.
213. See generally Andrews, supra note 82, at F23-F27 (reviewing state legislation and evaluating its effectiveness and shortcomings).
214. See discussion supra Part V.B.1.
215. See Andrews, supra note 197, at 184.
216. The Fertility Clinic Success Act of 1992 requires fertility clinics to report pregnancy success rates of in vitro fertilization and other procedures for publication in a consumer guide. See 42 U.S.C. § 293a-1 (1992). Although the federal government provides a model for accreditation programs, the Act does not impose mandatory guidelines or restrictions on the activities of fertility clinics. See 42 U.S.C. § 263a-2 (1992).
217. See Gregory J. Rokosz, Human Cloning: Is the Reach of FDA Authority Too Far a Stretch?, 30 SETON HALL L. REV. 464, 468 (2000) (observing that the FDA currently may not have authority to regulate cloning, but arguing that creating FDA regulation may be beneficial).
218. See Arthur A. Caplan, Why the Rush to Ban Cloning?, N.Y. TIMES, Jan. 28, 1998, at A25.
219. See id.
220. See Rick Weiss, U.S. Fertility Expert Announces Efforts to Clone a Human; Consortium Led by Renegade Doctor Says It Will Help Infertile Couples, WASH. POST, Jan. 27, 2001, at A3. Zanos and Antinori intend to carry out their plans in an unnamed Mediterranean country. See id.
221. See id.
222. See Nancy Gibbs, Baby, It's You! And You, And You . . ., TIME, Feb. 19, 2001, at 46.
223. See Stuart L. Nightingale, Dear Colleague Letter About Human Cloning (Oct. 26, 1998) (visited Mar. 15, 2001) 〈http://www.fda.gov/oc/oha/irbletr.html〉 (informing researchers that clinical investigation of cloning requires submitting an investigational new drug application with the FDA and following investigational new drug application procedures and requirements).
224. See id.
225. See id.
226. See Elizabeth C. Price, Does the FDA Have Authority to Regulate Human Cloning?, 11 HARV. J.L. & TECH. 619, 694 (1998) (arguing that the FDA does not have jurisdiction to regulate cloning as a "drug," "medical device" or "biological product").
227. See Andrews, supra note 197, at 184 (arguing that although governmental oversight is necessary, FDA regulation is not sufficient).
228. For a more thorough discussion of FDA jurisdiction of human cloning, see generally Price, supra note 216. See also Rokosz, supra note 207, at 491-511.
229. See Rokosz, supra note 207, at 501-07.
230. 21 U.S.C. § 201 (g)(1)(B), (C) (1997).
231. See Rokosz, supra note 207, at 502-03.
232. See id.
233. See id.
234. See Rokosz, supra note 207, at 507-11.
235. 21 U.S.C. § 201(h)(2),(3) (1997).
236. See Rokosz, supra note 207, at 510.
237. 42 U.S.C. § 351(i)(2000).
238. See Rokosz, supra note 207, at 497. Rokosz argues that a cloned embryo is not an "analogous product" because the products listed in the statute are components of a biological entity, whereas an embryo is a biological entity in itself, and therefore, cloned embryos are not "analogous products." See id. In contrast, Erb argues that live whole cell vaccines are biological entities (rather than components) regulated by the FDA, and therefore a cloned embryo is an "analogous product" within the meaning of section 351. See B. Jason Erb, Deconstructing the Human Egg: The FDA's Regulation of Scientifically Created Babies, 5 ROGER WILLIAMS U. L. REV. 273, 302-03 (1999).
239. See Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing, 66 Fed. Reg. 5447, 5447 (Jan. 19, 2001) (to be codified 21 C.F.R. pt. 1271) [hereinafter HCT/P Registration].
240. See HCT/P Registration, 66 Fed. Reg. at 5448.
241. See id.
242. See Suitability Determination for Donors of Human Cellular and Tissue-Based Products, 64 Fed. Reg. 52,696 (1999).
243. See Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement, 66 Fed. Reg. 1508 (2000).
244. See HCT/P Registration, 66 Fed. Reg. at 5448.
245. See id. at 5443. The regulation defines "immediate use" to include only reproductive tissues that are used promptly enough so that cryopreservation is not performed. See id. at 5460. Therefore, the regulations apply to establishments that deal with egg donation, retrieval, semen processing, and IVF, unless the "immediate use" exemption is satisfied. See id.
246. See HCT/P Registration, 66 Fed. Reg. at 5452.
247. See Rokosz, supra note 207, at 498-99 (stating that the FDA has been "inching toward" jurisdiction to regulate human cloning through rules relating to biological products and gene therapy).
248. See HCT/P Registration, 66 Fed. Reg. at 456.
249. Id. at 5457.
250. See Rokosz, supra note 207, at 501.
251. Several bills were introduced into both houses of Congress proposing to prohibit the cloning of human beings See e.g., S. 1611, 105th Cong. (1998); S. 1602, 105th Cong. (1998); S. 1601, 105th Cong. (1998); S. 1599, 105th Cong. (1998); S. 1574, 105th Cong. (1998); H.R. 923, 105th Cong. (1997). In addition, bills proposing to ban the use of federal funds for cloning research were introduced. See, e.g., H.R. 3133, 105th Cong. (1998); H.R. 922, 105th Cong. (1997); S. 368, 105th Cong. (1997).
252. See S. 1611, 105th Cong. § 4 (1998); S. 1602, 105th Cong. § 4 (1998). Both bills propose to amend the PHSA by adding section 498(C), which would prohibit the implantation of a cloned egg into a woman's uterus, but protect cloning research for scientific and therapeutic purposes.
253. As discussed supra in Part VI.A. and accompanying notes, proposed legislation at both the federal and state levels have unnecessarily or unintentionally created limitations to cloning research.
254. See Administrative Procedure Act § 4, 5 U.S.C. § 553 (1998). The statute provides, in relevant part that "[a]fter notice required by this section, the agency shall give interested persons an opportunity to participate in the rulemaking through submission of written data, views, or arguments with or without opportunity for oral presentation. After consideration of the relevant matter presented, the agency shall incorporate in the rules adopted a concise general statement of their basis and purpose." 5 U.S.C. § 553(c) (1998).
255. Under the definition of "drug" as defined by the FDCA, an embryo may be considered an 'article intended to cure disease' if it is created and then differentiated to become a specific organ for transplant. See Price, supra note 216, at 631. Consequently, if a human embryo is considered an article under the drug definition of the FDCA, the FDA does have jurisdiction over therapeutic uses of cloning technology. See id. at 632.
256. The need for regulation of cloning and germline gene therapy is highlighted by recent events concerning somatic cell gene therapy clinical studies. Unlike cloning and germline gene therapy, somatic cell therapy is a process by which genes are introduced into the cells of the body and intended to cure or mitigate a diseased condition without transmission of the therapy to progeny. See Center for Biologics Evaluation and Research, Guidance for Human Somatic Cell Therapy and Gene Therapy (visited Nov 11, 1999) 〈http://www.fda.gov/cber/gdlns/somgene.txt〉. The FDA has jurisdiction over omatic cell gene therapy under 42 U.S.C. § 351(I). Recently, the FDA halted several studies because researchers failed to comply with FDA and National Institutes of Health Recombinant DNA Advisory Committee ("NIH-RAC") guidelines. See Jeffrey Brainard, Penn Disputes Charges from Death in Research, CHRON. HIGHER EDUC., Feb. 25, 2000, at A41. These guidelines are now being reevaluated in an effort to ensure the safety of human subjects and compliance by researchers. See Marlene Cimons, NIH to Order New Reports on Past Gene Therapy Cases, L.A. TIMES, Feb. 24, 2000, at A1.
257. The need for regulation of cloning and germline gene therapy is highlighted by recent events concerning somatic cell gene therapy clinical studies. Unlike cloning and germline gene therapy, somatic cell therapy is a process by which genes are introduced into the cells of the body and intended to cure or mitigate a diseased condition without transmission of the therapy to progeny. See Center for Biologics Evaluation and Research, Guidance for Human Somatic Cell Therapy and Gene Therapy (visited Nov 11, 1999) 〈http://www.fda.gov/cber/gdlns/somgene.txt〉. The FDA has jurisdiction over omatic cell gene therapy under 42 U.S.C. § 351(I). Recently, the FDA halted several studies because researchers failed to comply with FDA and National Institutes of Health Recombinant DNA Advisory Committee ("NIH-RAC") guidelines. See Jeffrey Brainard, Penn Disputes Charges from Death in Research, CHRON. HIGHER EDUC., Feb. 25, 2000, at A41. These guidelines are now being reevaluated in an effort to ensure the safety of human subjects and compliance by researchers. See Marlene Cimons, NIH to Order New Reports on Past Gene Therapy Cases, L.A. TIMES, Feb. 24, 2000, at A1.
258. The need for regulation of cloning and germline gene therapy is highlighted by recent events concerning somatic cell gene therapy clinical studies. Unlike cloning and germline gene therapy, somatic cell therapy is a process by which genes are introduced into the cells of the body and intended to cure or mitigate a diseased condition without transmission of the therapy to progeny. See Center for Biologics Evaluation and Research, Guidance for Human Somatic Cell Therapy and Gene Therapy (visited Nov 11, 1999) 〈http://www.fda.gov/cber/gdlns/somgene.txt〉. The FDA has jurisdiction over omatic cell gene therapy under 42 U.S.C. § 351(I). Recently, the FDA halted several studies because researchers failed to comply with FDA and National Institutes of Health Recombinant DNA Advisory Committee ("NIH-RAC") guidelines. See Jeffrey Brainard, Penn Disputes Charges from Death in Research, CHRON. HIGHER EDUC., Feb. 25, 2000, at A41. These guidelines are now being reevaluated in an effort to ensure the safety of human subjects and compliance by researchers. See Marlene Cimons, NIH to Order New Reports on Past Gene Therapy Cases, L.A. TIMES, Feb. 24, 2000, at A1.
259. See Nightingale, supra note 213.
260. See id.
261. See id. The FDA has recently used its authority to halt studies of somatic cell gene therapy in which researchers did not promptly report deaths as required by FDA and NIH-RAC guidelines. See Brainard, supra note 246, at A41. In response, some institutions voluntarily halted their own gene therapy studies. See, e.g., Richard Saltus, Beth Israel Halts Trial of Gene Therapy, BOSTON GLOBE, Feb. 7, 2000, at A1. The Biotechnology Industry Organization declared its intolerance of violations and willingness to cooperate with the NIH and FDA to reevaluate and/or restructure the current reporting guidelines. See H. Stewart Parker, Testimony of H. Stewart Parker Chief Executive Officer, Targeted Genetics Corporation Before the U.S. Senate Health, Education, Labor and Pensions Subcommittee on Public Health, Feb. 2, 2000 (visited Feb. 27, 2000) 〈http://www.bio.org/laws/tstm020200.html〉.
262. See id. The FDA has recently used its authority to halt studies of somatic cell gene therapy in which researchers did not promptly report deaths as required by FDA and NIH-RAC guidelines. See Brainard, supra note 246, at A41. In response, some institutions voluntarily halted their own gene therapy studies. See, e.g., Richard Saltus, Beth Israel Halts Trial of Gene Therapy, BOSTON GLOBE, Feb. 7, 2000, at A1. The Biotechnology Industry Organization declared its intolerance of violations and willingness to cooperate with the NIH and FDA to reevaluate and/or restructure the current reporting guidelines. See H. Stewart Parker, Testimony of H. Stewart Parker Chief Executive Officer, Targeted Genetics Corporation Before the U.S. Senate Health, Education, Labor and Pensions Subcommittee on Public Health, Feb. 2, 2000 (visited Feb. 27, 2000) 〈http://www.bio.org/laws/tstm020200.html〉.
263. See CLONING HUMAN BEINGS, supra note 4, at 95 (acknowledging that time will play an important role as to whether cloning is accepted or rejected in the future and suggesting that the outcome will primarily depend upon further experimentation).
264. In contrast, most federal legislation prohibits funding only for institutions that receive federal funding. See discussion supra Parts V.A. and V.B.2.
265. See Nightingale, supra note 213 (stating that the FDA will allow clinical research of cloning only after an IND is in effect).
266. See Biotechnology Industry Organization, There Is No Need for a Rush to Legislate; Pending Bills Regarding Human Cloning Would Inadvertently Ban Vital Biomedical Research For Treatment of Disease (visited Feb. 27, 2000) 〈http://www.bio.org/bioethics/clonmg_paperl.html〉.
267. See Biotechnology Industry Organization, BIO Response to NBAC on Stem Cell Research (visited Feb. 27, 2000) 〈http://www.bio.org/bioethics/stemcell.html〉.
268. See id.
269. See id.
270. See discussion supra Part VI.B. and accompanying notes.
271. See id.
272. See BIOTECHNOLOGY INDUSTRY ORGANIZATION, supra note 253.
273. See Andrews, supra note 197, at 181.
274. See id. at 184 (noting the need for debating the advisability of particular reproductive services).
275. See Susan M. Wolf, A Proposed Cloning Ban Unconstitutionally Restricts Scientific Research, in CLONING, FOR AND AGAINST, supra note 92, at 250, 255 (advocating a regulatory approach that combines agency regulation with an advisory body to discuss novel issues).
276. See id.
277. See id. The NIH-RAC is a public advisory committee that consists of scientists, physicians, medical ethicists, consumer activists and governmental officials. See FDA Center for Biologics Evaluation and Research, Human Gene Therapy and the Role of the Food & Drug Administration (visited Feb. 15, 2001) 〈http://www.fda.gov/cber/infosheets/gene.htm〉. The NIH-RAC focuses on the safety, scientific and ethical issues involved in gene therapy, and reports its findings to the FDA. See id.