Use of Cloning Technology to Clone a Human Being
As a consequence of scientific and biotechnological progress
during the past decades, new biological therapies involving somatic
cells and genetic material are being investigated. The Food and Drug
Administration (FDA) described existing legal authorities governing
a new class of human somatic cell therapy products and gene therapy
products in an October 14,
1993 Federal Register Notice.
On February 23, 1997, the public learned that Ian Wilmut, a
Scottish scientist, and his colleagues at the Roslin Institute
successfully used a technique called somatic cell nuclear transfer
(SCNT) to create a clone of a sheep; the cloned sheep was named
Dolly. SCNT involves transferring the nucleus of an adult sheep
somatic cell, into a sheep egg from which the nucleus had been
removed. After nearly 300 attempts, the cloned sheep known as Dolly
was born to a surrogate sheep mother.
SCNT is not reproduction since a sperm cannot be used with the
technique, but rather it is an extension of technology used not only
in research but also used to produce medically relevant cellular
products such as cartilage cells for knees, as well as gene therapy
products. On February 28, 1997, FDA announced a comprehensive plan
for the regulation of cell and tissue based therapies that
incorporated the legal authorities described in FDA’s 1993 guidance
"Proposed
Approach to Regulation of Cellular and Tissue-Based Products
On March 7, 1997 then President Clinton issued a memorandum that
stated: “Recent accounts of advances in cloning technology,
including the first successful cloning of an adult sheep, raise
important questions. They potentially represent enormous scientific
breakthroughs that could offer benefits in such areas as medicine
and agriculture. But the new technology also raises profound ethical
issues, particularly with respect to its possible use to clone
humans.” (Prohibitions on Federal Funding
for Cloning of Human Beings)
The memorandum explicitly prohibited Federal Funding for cloning
of a human being, and also directed the National Bioethics Advisory
Commission (NBAC) to thoroughly review the legal and ethical issues
associated with the use of cloning technology to create a human
being.
“NBAC found that concerns relating to the potential psychological
harms to children and effects on the moral, religious, and cultural
values of society merited further reflection and deliberation.” The
report, Ethical Issues in Human Stem
Cell Research, September 1999, describes 5 recommendations.
Somatic cell nuclear transfer holds great potential to someday
create medically useful therapeutic products. FDA believes, however,
that there are major unresolved questions pertaining to the use of
cloning technology to clone a human being which must be seriously
considered and resolved before the Agency would permit such
investigation to proceed. The Agency sent a "Dear Colleague” letter which stated that creating
a human being using cloning technology is subject to FDA regulation
under the Public Health Service Act and the Food Drug and Cosmetic
Act. This letter notified researchers that clinical research using
SCNT to create a human being could precede only when an
investigational new drug application (IND) is in effect. Sponsors
are required to submit to FDA
Recently, FDA sent letters to remind the research community that
FDA jurisdiction over clinical research using cloning technology to
create a human being, and to advise that FDA regulatory process is
required in order to initial these investigations. (March 2001
letter - PDF,
Text)
On March 28, 2001, Dr. Kathryn C. Zoon, Director, Center for
Biologics Evaluation and Research gave testimony before the Subcommittee on Oversight and
Investigations Committee on Energy and Commerce, United States
House of Representatives. Her statement described FDA’s role in
regulating the use of cloning technology to clone a human being and
further described current significant scientific concerns in this
area.
Last Updated:
12/27/2002
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