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)
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.
Letter to Sponsors / Researchers - Human Cells Used in Therapy Involving the Transfer of Genetic Material By Means Other Than the Union of Gamete Nuclei Application of Current Statuatory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products(PDF - 489KB) Letter to Associations - Cloning Technology Letter about Human Cloning