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

Article excerpt

I. INTRODUCTION

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.1 Although the scientists who created the sheep named Dolly did not intend to apply cloning techniques to human beings,2 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 research3 and requested the National Bioethics Advisory Commission to prepare a report evaluating the technology and making recommendations concerning its use.4 Several bills were introduced in Congress which prohibited federal funding and/or banned cloning in both the public and private sectors.5 As of yet, none of these bills have been passed.

Debate surrounding the cloning of humans has focused primarily on the moral and ethical propriety of manipulating the human genome, as well as on the potential social and physical harms which may result to the clonal child and gestational mother.6 Beyond the ethical implications of creating clones lies the fear of a new eugenics movement.7 Current medical and scientific opinion is undivided: cloning humans is unsafe at this time.8 Such fears are therefore largely speculative and may be the result of public ignorance, misunderstanding and misinformation.9

Despite the potential for harm and abuse of cloning techniques, many scientists and politicians advocate continuing cloning research.10 Advocates of cloning research recognize its potential to benefit human existence.ll Apart from use as an assisted reproductive technology, cloning techniques have many applications in basic scientific research, and may contribute to therapies or cures for diabetes, heart disease, cancer, organ transplantation and other diseases.12 Many of the proposed bans on human cloning also extend to research applications of cloning technology in these areas.13

This Note will analyze human cloning technology in the context of current and developing assisted reproductive technologies. In particular, parallels between the issues arising in cloning and germline gene therapy will be explored. Part II of this Note will describe the processes of human cloning and germline gene therapy. It will discuss the current state of each technology, and the scientific advances necessary before each may be considered safe for human use. Part III will discuss the potential uses of these technologies, focusing primarily on the research potential of cloning techniques. Part IV will present arguments against human cloning and analyze their validity. Throughout this section, human cloning and germline gene therapy will be compared in order to emphasize that the ethical, social and eugenics arguments advanced to prohibit cloning are not unique to asexual reproduction. Part V will discuss the legislative response to the prospect of human cloning and analyze the constitutionality of a ban on human cloning. Part VI will discuss the benefits of regulating, rather than banning, cloning and germline gene therapy technology. This section will also discuss current regulation of these technologies, and propose that the Food and Drug Administration may effectively monitor the development of both cloning and germline gene therapy.

II. CLONING AND GERMLINE GENE THERAPY TECHNOLOGIES

A. HUMAN CLONING

"Human cloning," as used in this Note, is the process of somatic cell nuclear transfer to create a human embryo which has the potential to be implanted into a woman's uterus and develop into a child.14 "Human cloning techniques" or "cloning techniques," for the purposes of this discussion, refers to the process of somatic cell nuclear transfer to create a human embryo, absent the intent to allow the embryo to develop into a child. …