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

Published online by Cambridge University Press:  24 February 2021

Christine Willgoos
Christine Willgoos*
Affiliation:
Biochemistry, State University of New York College at Geneseo, 1995; Forensic Molecular Biology, The George Washington University, 1997; , Boston University School of Law, 2001
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Extract

The possibility of cloning human beings, although widely contemplated for several decades, became scientifically feasible in 1997 when the first mammal created through cloning procedures was born. Although the scientists who created the sheep named Dolly did not intend to apply cloning techniques to human beings, news media worldwide began predicting such an application.

In the United States, public and political outcry against the possibility of cloning human beings was loud and swift. Almost immediately, President Clinton announced a ban on federal funding of cloning research and requested the National Bioethics Advisory Commission to prepare a report evaluating the technology and making recommendations concerning its use. Several bills were introduced in Congress which prohibited federal funding and/or banned cloning in both the public and private sectors. As of yet, none of these bills have been passed.

Type
Notes and Comments
Information
American Journal of Law & Medicine , Volume 27 , Issue 1 , 2001 , pp. 101 - 124
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2020

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References

1 See Wilmut, Ian et al., Viable Offspring Derived from Fetal and Adult Mammalian Cells, 385 Nature 810, 812 (1997)CrossRefGoogle Scholar (reporting on the birth of lambs from cells established from fetal and adult mammary glands).

2 See Firn, David, Roslin Institute Upset By Human Cloning Suggestions, 5 Nature Medicine 253, 253 (1999)CrossRefGoogle Scholar (observing that the scientific director of the Roslin Institute “[RJeacted 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)Google Scholar (reporting that no federal funds be used for the cloning of humans).

4 See ational Bioethics Advisory Commission, Cloning Human Beings—report And Recommendations of the National Bioethics Advisory Commission, June 1997Google Scholar, at 2 (“[AJddressing 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 discussion infra Part V.B.2. and accompanying notes.

6 See discussion infra Part III. and accompanying notes.

7 See Mirsky, Steve & Rennie, John, What Cloning Means for Gene Therapy, 276 Scientific American, 122, 123 (1997)CrossRefGoogle Scholar (noting that researchers and the general public are concerned about the potential for misapplication of gene therapy “toward eugenic goals”). See also Billings, Paul R. et al., Human Germline Gene Modification: A Dissent, 353 The Lancet 1873Google Scholar, 1874 (1999) (asserting that germline intervention is an individual or familial form of eugenics).

8 See Cloning Human Beings, supraGoogle Scholar 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).

9 See generally Katz, Kathryn D., The Clonal Child: Procreative Liberty and Asexual Reproduction, 8 Alb. L.J. Sci. & TECH. 1, 15-23 (1997)Google Scholar (discussing common misconceptions regarding human cloning).

10 See Kolata, Gina, Congress is Cautioned Against Ban on Human-Cloning Work, N.Y. Times, Mar. 13, 1997Google Scholar, at Bll.

11 See id.

12 See Lanza, Robert P. et al., Human Therapeutic Cloning, 5 Nature Medicine 975, 975 (1999)Google Scholar (discussing the potential uses for human therapeutic cloning).

13 See, e.g., H.R. 571, 106th Cong. (1999); H.R. 2326, 106th Cong. (1999).

14 See Katz, , supraGoogle Scholar note 9, at 3 (discussing human cloning as a means to create individuals who are genetically identical to existing or deceased persons).

15 See Lanza, et al., supraGoogle Scholar note 12, at 975 (discussing the possible uses of therapeutic cloning).

16 The term “cloning” is used in other contexts to refer to the replication of a single cell to create a colony. See Alberts, Bruce Et al., Molecular Biology of the Cell 162 (2d ed. 1989)Google Scholar. 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.

17 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 Gardner, Eldon John Et al., Principles of Genetics Gil (8th ed. 1991)Google Scholar.

18 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.htmGoogle Scholar>. 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.

19 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 Solter, Davor, Dolly Is a Clone—and No Longer Alone, 394 Nature 315, 315 (1998)CrossRefGoogle ScholarPubMed (describing techniques used in cloning mice).

20 See, e.g., Wilmut, et al., supraGoogle Scholar note 1, at 812-13; Wakayama, T. et al., Full-term Development of Mice From Enucleated Oocytes Injected with Cumulus Cell Nuclei, 394 Nature 369, 373 (1998)Google Scholar (discussing various methods of nuclear transfer).

21 See Mirsky, & Rennie, , supraGoogle Scholar note 7, at 122.

22 Although generally considered a genetic twin, the cloned individual may not have the identical genetic makeup of the donor. See Bouma, Hessel, Ethical Considerations in Human Cloning, 125 Surgery 468, 468 (1999)CrossRefGoogle Scholar. 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.

23 See Cloning Human Beings, supraGoogle Scholar note 4, at 95.

24 The scientists who created Dolly the sheep had a success rate of one surviving sheep out of 277 nuclear transfers. See Cloning Human Beings, supraGoogle Scholar 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., supraGoogle Scholar note 20, at 371.

25 See Shiels, Paul et al., Analysis of Telomere Lengths in Cloned Sheep, 399 Nature 316, 317 (1999)CrossRefGoogle Scholar (finding a significant difference between the cells from cloned animals and those of age-matched control animals). Cf. Wade, Nicholas, Experimentation on Cow's Cells Offers More Hope for Cloning, N.Y. Times, Apr. 28, 2000Google Scholar, at A18 (reporting that cloned cows had normal telomere lengths and, therefore, should live at least as long as cows not produced through cloning).

26 See Morris, J.A., Effects of Somatic Cloning, 354 The Lancet 255, 255 (1999)CrossRefGoogle Scholar (arguing that cloning will lead to an increased chance of impaired development, impaired function and polygenic disease).

27 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 Kato, Yoko et al., Eight Calves Cloned from Somatic Cells of a Single Adult, 282 Science 2095, 2095 (1998)CrossRefGoogle Scholar (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 Watts, Jonathan & Morris, Kelly, Human Cloning Trial Met with Outrage and Scepticism, 353 The Lancet 43, 43 (1999)CrossRefGoogle Scholar (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.

28 See supra text accompanying note 24; see also Kato, supra note 27, at 2097.

29 See Perils in Free Market Genomics, 392 Nature 315, 315 (1998)Google Scholar (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).

30 See id.

31 See Weiss, Rick, Embryo Work Raises Specter Of Human Harvesting; Medical Research Teams Draw Closer to Cloning, Wash. Post, June 14, 1999Google Scholar, at Al. 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.

32 See id.

33 See id.

34 See Ethics Committee Report, Human Somatic Cell Nuclear Transfer (Cloning), Fertility & Sterility, Nov. 2000Google Scholar, at 873, 873 (stating that “improvements in animal cloning indicate that safety concerns may be only a temporary barrier to reproductive [cloning] in humans”).

35 See Wertz, Dorothy C., Germline Gene Therapy: Is it Almost Here?, The Gene Letter (Mar. 1997) (visited Mar. 19, 2001) <http://www.geneletter.com/archives/germlinetherapy.htmlGoogle Scholar>.

36 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 Walters, LeRoy, The Ethics of Human Gene Therapy, 320 Nature 225, 225 (1986)Google Scholar. 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.

37 See id.

38 See Mirsky & Rennie, supra note 7, at 122.

39 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.

40 A vector is a biological vehicle used to introduce recombinant DNA into living cells. See Gardner ET AL., supra note 17, at G12.

41 See Mirsky & Rennie, supra note 7, at 123.

42 See id.

43 See Wadman, Meredith, Germline Gene Therapy 'Musi Be Spared Excessive Regulation', 392 Nature 317, 317 (1998)Google Scholar (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).

44 See id.

45 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>.

46 See id. (stating that knowledge of the human genome can lead to new ways to diagnose, treat and prevent thousands of disorders affecting humans).

47 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 Jacobs, Paul, Not Feeling Well? The Microchip Will See You Now, L.A.Times, Nov. 29, 1999Google Scholar, at CI. 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.

48 A gamete is a mature reproductive cell; an egg or a sperm cell. See Gardner et al., supra note 17, atG5.

49 See Mirsky & Rennie, supra note 7, at 122-23. See also discussion infra Part IV.A. and accompanying notes.

50 See id.

51 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.

52 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.

53 See id.

54 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).

55 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.

56 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).

57 See, e.g., Wilson, Robert, Note, Environmental Regulation of the Human Gene Pool as a Genetic Commons, 5 N.Y.U. Envtl. L.J. 833, 846 (1996)Google Scholar.

58 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.

59 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.

61 See Gardner et al., supra note 17, at 581.

62 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.

63 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).

64 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).

65 See Andrews, Lori B., Is There a Right to Clone? Constitutional Challenges to Bans on Human Cloning, 11 Harv. L.J. 643, 668 (1998)Google Scholar (arguing that human cloning may be a form of “genetic bondage” that violates the Thirteenth Amendment prohibition against slavery).

66 See Savulescu, Julian, Should We Clone Human Beings? Cloning as a Source of Tissue for Transplantation, 25 J. MED. ETHICS 87, 91 (1999)CrossRefGoogle Scholar (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).

67 See Katz, supra note 9, at 17 (discussing the fear that clones will be viewed as less than human).

68 See Cloning Human Beings, supra note 4, at 50-51.

69 See Ehlers, Vernon J., The Case Against Human Cloning, 27 Hofstra L. REV. 523, 526-27 (1999)Google Scholar.

70 See id.

71 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).

72 See id.

73 See Andrews, supra note 65, at 653-57 (arguing that a cloned child may seem more like an object than a person).

74 See id. at 655-56.

75 See id.

76 See id.

77 See Wertz, Dorothy C., 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>Google Scholar (rebutting common arguments against cloning humans, but also arguing the unpredictability of psychological impacts on cloned children remains the strongest argument against cloning).

78 See id. (stating that there is no reason to prejudge potential families with cloned children).

79 See id.

80 See Robertson, John A., Two Models of Human Cloning, 27 Hofstra L. REV 609, 624 (1999)Google Scholar (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).

81 See, e.g., Wadman, supra note 43, at 317.

82 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).

83 See Perils in Free Market Genomics, supra note 29, at 315.

84 See Morris, supra note 26, at 255.

85 See Cloning Human Beings, supra note 4, at 29; see also discussion supra Part III.A.l.

86 See Cloning Human Beings, supra note 4, at 29.

87 See Morris, supra note 26, at 255.

88 See discussion supra note 59.

89 See Morris, supra note 26, at 255 (arguing that cloning will lead to an increased chance of impaired development, impaired function and polygenic disease).

90 See Cloning Human Beings, supra note 4, at 29 (discussing that mutations in genes can predispose a cell to become cancerous).

91 See Morris, supra note 26, at 255.

92 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).

93 See Walters, supra note 36, at 225.

94 See id.

95 See id.

96 See Daniel, supra note 92, at 37.

97 See Firn, David, Deal Creates Lead Cloning Company, 5 Nature Medicine 595, 595 (1999)CrossRefGoogle Scholar (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).

98 See generally Cloning Human Beings, supra note 4 (discussing the fears, concerns and moral reservations about the potential abuse of the new technology).

99 See Campbell, Paula et al., Symposium: Gene Therapy: Legal, Financial and Ethical Issues, 4 B.U. J. SCI. & TECH. L. 3, ¶ 60 (1998)Google Scholar (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).

100 See Andrews, supra note 65, at 653.

101 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).

102 See id., supra note 4, at 36-38 (discussing genetic determinism).

103 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).

104 See id. at E12 (arguing that sharing an identical genome does not prevent twins from developing distinct personal identities).

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).

106 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).

107 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.

108 See Walters, supra note 36, at 225 (stating that the first attempts at germline gene therapy will be for monogenic disorders).

109 See Gardner et al., supra note 17, at 248.

110 See Brock, supra note 103, at E9-E10.

111 See id.

112 See id.

113 See, e.g., id. at E20 (asserting that sexual forms of reproduction will remain the norm).

114 See Mirsky & Rennie, supra note 7, at 123.

115 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).

116 See id.

117 See Coleman, June, Playing God or Playing Scientist: A Constitutional Analysis of State Laws Banning Embryological Procedures, 27 Pacific L.J. 1331, 1353-60(1996)Google ScholarPubMed.

118 See id.

119 See Robertson, supra note 80, at 621-22.

120 See id.

121 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.

122 See Mirsky & Rennie, supra note 7, at 122.

123 See id. at 122-23 (explaining how germline gene therapy could create a healthy embryo through cloning techniques).

124 See Robertson, supra note 80, at 622.

125 See id.

126 See id.

127 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.

128 See Mirsky & Rennie, supra note 7, at 123.

129 See discussion supra Part II.B. and accompanying notes.

130 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.

131 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.

132 See supra text accompanying note 19.

133 See Cloning Human Beings, supra note 4, at 33-34.

134 See id.

135 See Lanza, supra note 12, at 976-77.

136 See id.

137 See Abbas, et al., Cellular and Molecular Immunology 347 (1994)Google Scholar. 138

138 See Weiss, supra note 31, at Al.

139 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).

140 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.htmlGoogle Scholar. 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.

141 See Cloning Human Beings, supra note 4, at 38.

142 See Firn, supra note 97, at 595 (reporting efforts to reprogram human cells without using eggs or creating embryos).

143 See Pub. L. 106-113 § 510 (1999).

144 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.htmlGoogle Scholar>. 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.

145 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.

146 See National Institutes of Health, Directive on Human Embryo Research (visited Mar. 11, 2001) <http://www.grants.nih.gov/grants/policy/humanembryo.htmlGoogle Scholar>.

147 See generally Andrews, supra note 82.

148 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).

149 See Biotechnology Industry Organization, Gene Therapy (visited Feb. 27, 2000) <http://www.bio.org/bioethics/genetherapy.htmlGoogle Scholar> (stating that this moratorium has been in place for over ten years).

150 See Memorandum on the Prohibition of Federal Funding for Cloning of Human Beings, supra note 3, at 281.

151 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.

152 See Cloning Human Beings, supra note 4, at 95-96.

153 See id. at 96.

154 See id.

155 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).

156 See Andrews, supra note 65, at 661-69.

157 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”).

158 See irf.

159 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).

160 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).

161 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).

162 See Lawton, Anne, The Frankenstein Controversy: The Constitutionality of a Federal Ban on Cloning, 87 K.Y. L.J. 277, 334 (1998-99)Google Scholar (arguing that a right to cloning will not likely be recognized as a fundamental right based on prior jurisprudence).

163 See Lifchez v. Hartigan, 735 F. Supp. 1361, 1377 (N.D. 111. 1990), affd mem., 914 F.2d 260 (7th Cir. 1990).

164 See id. at 1377.

165 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).

166 See id. at 662.

167 See id. at 663.

168 See id.

169 See U.S. CONST, art. I, § 8, cl. 3.

170 See Andrews, supra note 65, at 669.

171 See Wickard v. Filburn, 317 U.S. 111, 125 (1942) (discussing when an activity can be reached by Congress).

172 See Andrews, supra note 65, at 670-75 (discussing Supreme Court decisions which have upheld federal legislation as proper under the Commerce Clause).

173 See id. at 672-73.

174 See Andrews, supra note 82, at F34-F35.

175 See Andrews, supra note 65, at 673.

176 See S. 368, 105th Cong. (1997); H.R. 922, 105th Cong. (1997); H.R. 923, 105th Cong. (1997).

177 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).

178 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.

179 See H.R. 922, 105th Cong. (1997); H.R. 923, 105th Cong. (1997).

180 A somatic cell is generally considered a fully differentiated cell of the body. See Gardner et al., supra note 17, at Gil. 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).

181 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.”).

182 See S. 1599, 105th Cong. (1998) (“It shall be unlawful for any person . . . to use human somatic cell nuclear transfer technology.”).

183 See S. 1601, 105th Cong. (1998) (“It shall be unlawful for any person . . . to use human somatic cell nuclear transfer technology.”).

184 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.

185 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).

186 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.

187 See H.R. 571, 106th Cong. (1999); H.R. 2326, 106th Cong. (1999).

188 “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).

189 “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).

190 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.

191 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.

192 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.

193 See discussion supra Part V.A. and accompanying notes.

194 See Perils in Free Market Genomics, supra note 29, at 315.

195 See Berg, Paul & Singer, Maxine, Regulating Human Cloning, 282 Science 413, 413 (1998)CrossRefGoogle Scholar (arguing that legislation is not the best tool for regulating scientific development).

196 See Andrews, supra note 82, at F31.

197 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).

198 See Bonnicksen, Andrea L., The Politics of Germline Therapy, 19 Nature Genetics 10, 11 (1998)CrossRefGoogle Scholar (arguing that public discussion of scientific advancement is necessary to help guide research).

199 See id. at 10.

200 Id. at 11.

201 See Coleman, supra note 117, at 1349-52.

202 See Andrews, supra note 65, at 660.

203 See generally Andrews, supra note 82, at F23-F27 (reviewing state legislation and evaluating its effectiveness and shortcomings).

204 See discussion supra Part V.B.I.

205 See Andrews, supra note 197, at 184.

206 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-l (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).

207 See Rokosz, Gregory J., Human Cloning: Is the Reach of FDA Authority Too Far a Stretch?, 30 Seton Hall L. REV. 464, 468 (2000)Google Scholar (observing that the FDA currently may not have authority to regulate cloning, but arguing that creating FDA regulation may be beneficial).

208 See Caplan, Arthur A., Why the Rush to Ban Cloning?, N.Y. TIMES, Jan. 28, 1998Google Scholar, at A25.

209 See id.

210 See Weiss, Rick, 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, 2001Google Scholar, at A3. Zanos and Antinori intend to carry out their plans in an unnamed Mediterranean country. See id.

211 See id.

212 See Gibbs, Nancy, Baby, It's You! And You, And You . . ., TIME, Feb. 19, 2001Google Scholar, at 46.

213 See Nightingale, Stuart L., Dear Colleague Letter About Human Cloning (Oct. 26, 1998) (visited Mar. 15, 2001) <http://www.fda.gov/oc/oha/irbletr.htmlGoogle Scholar> (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).

214 See id.

215 See id.

216 See Price, Elizabeth C., Does the FDA Have Authority to Regulate Human Cloning?, 11 HARV. J.L. & TECH. 619, 694 (1998)Google Scholar (arguing that the FDA does not have jurisdiction to regulate cloning as a “drug,” “medical device” or “biological product”).

217 See Andrews, supra note 197, at 184 (arguing that although governmental oversight is necessary, FDA regulation is not sufficient).

218 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.

219 See Rokosz, supra note 207, at 501-07.

220 21 U.S.C. § 201(g)(1)(B), (C) (1997).

221 See Rokosz, supra note 207, at 502-03.

222 See id.

223 See id.

224 See Rokosz, supra note 207, at 507-11.

225 21 U.S.C. § 201(h)(2),(3) (1997).

226 See Rokosz, supra note 207, at 510.

227 42 U.S.C. §351(i) (2000).

228 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 Erb, B. Jason, Deconstructing the Human Egg: The FDA's Regulation of Scientifically Created Babies, 5 Roger Williams U. L. REV. 273, 302-03 (1999)Google Scholar.

229 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].

230 See HCT/P Registration, 66 Fed. Reg. at 5448.

231 See id.

232 See Suitability Determination for Donors of Human Cellular and Tissue-Based Products, 64 Fed. Reg. 52,696(1999).

233 See Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement, 66 Fed. Reg. 1508 (2000).

234 See HCT/P Registration, 66 Fed. Reg. at 5448.

235 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.

236 See HCT/P Registration, 66 Fed. Reg. at 5452.

237 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).

238 See HCT/P Registration, 66 Fed. Reg. at 5456.

239 Id. at 5457.

240 See Rokosz, supra note 207, at 501.

241 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).

242 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.

243 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.

244 See Administrative Procedure Act § 4, 5 U.S.C. § 553 (1998). The statute provides, in relevant part, that “[ajfter 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).

245 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.

246 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 Biologies 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 somatic cell gene therapy under 42 U.S.C. § 351(1). 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 Brainard, Jeffrey, Penn Disputes Charges from Death in Research, Chron. Higher EDUC, Feb. 25, 2000Google Scholar, at A41. These guidelines are now being reevaluated in an effort to ensure the safety of human subjects and compliance by researchers. See Cimons, Marlene, NIH to Order New Reports on Past Gene Therapy Cases, L.A. TIMES, Feb. 24, 2000Google Scholar, at Al.

247 See Nightingale, supra note 213.

248 See id.

249 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., Saltus, Richard, Beth Israel Halts Trial of Gene Therapy, Boston Globe, Feb. 7, 2000Google Scholar, at Al. 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 Parker, H. Stewart, 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.htmlGoogle Scholar>.

250 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).

251 In contrast, most federal legislation prohibits funding only for institutions that receive federal funding. See discussion supra Parts V.A. and V.B.2.

252 See Nightingale, supra note 213 (stating that the FDA will allow clinical research of cloning only after an IND is in effect).

253 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/cloning_paperl.htmlGoogle Scholar>.

254 See Biotechnology Industry Organization, BIO Response to NBAC on Stem Cell Research (visited Feb. 27, 2000) <http://www.bio.org/bioethics/stemcell.htmlGoogle Scholar>.

255 See id.

256 See id.

257 See discussion supra Part VLB. and accompanying notes.

258 See id.

259 See Biotechnology Industry Organization, supra note 253.

260 See Andrews, supra note 197, at 181.

261 See id. at 184 (noting the need for debating the advisability of particular reproductive services).

262 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).

263 See id.

264 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 Biologies 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.