FDA Regulation: An Answer to the Questions of Human Cloning and Germline Gene Therapy
![handle is hein.journals/amlmed27 and id is 109 raw text is: American Journal of Law & Medicine, 27 (2001): 101-124
© 2001 American Society of Law, Medicine & Ethics
Boston University School of Law
FDA Regulation: An Answer to the
Questions of Human Cloning and
Germline Gene Therapy
Christine Willgoost
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.
t B.S. Biochemistry, State University of New York College at Geneseo, 1995; M.F.S. Forensic
Molecular Biology, The George Washington University, 1997; J.D. Candidate, Boston University
School of Law, 2001. 1 would like to thank Jamie Narbaitz, Kathleen Gabriel, and the staff of the
American Journal of Law & Medicine for their invaluable editing assistance. Particular thanks go to
Joanna Bergmann for her diligence in managing this Note. Most importantly, I thank my parents for
their boundless love and encouragement. This Note is dedicated to Katherine Regan and John
Willgoos.
I 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 discussion infra Part V.B.2. and accompanying notes.](ViewImageLocal?handle=hein.journals/amlmed27&div=11&collection=&method=preview&ext=.png&size=3)
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FDA Regulation: An Answer to the Questions of Human Cloning and Germline Gene Therapy
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