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STATEMENT BY

CLAUDE A. ALLEN

DEPUTY SECRETARY

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE

SUBCOMMITTEE ON HEALTH

COMMITTEE ON ENERGY AND COMMERCE

UNITED STATES HOUSE OF REPRESENTATIVES

JUNE 20, 2001

RELEASE ONLY UPON DELIVERY

Mr. Chairman and Members of the Committee, I am Claude Allen, Deputy Secretary of the Department of Health and Human Services. I appreciate this opportunity to discuss the position of the Administration regarding the cloning of human beings.

BACKGROUND

The moral and ethical issues posed by the prospect of cloning human beings are profound and demand our unflagging attention. Secretary Thompson and President Bush oppose any and all attempts to clone a human being. We oppose the use of human somatic cell nuclear transfer cloning techniques either to assist human reproduction or to develop cell- or tissue-based therapies. At the same time, we strongly support other approaches to development of these therapies, such as research with genes, cells, or tissues from humans or animals, consistent with current law.

Any attempt to clone a human being not only would present a grave risk to the mother and the child but also would pose deeply troubling moral and ethical issues for humankind. Further, we support both the Presidential directive already in place that prohibits the use of federal funds for cloning human beings and the current restrictions on HHS appropriations that bar the use of federal funds to create human embryos for research.

These matters are of special interest to the Department of Health and Human Services because attempts to use cloning technology to clone a human being are subject to both the biologics provisions of the Public Health Service Act and the drug and device provisions of the Federal Food, Drug, and Cosmetic Act. On March 28, an FDA representative testified on this subject before the House Energy and Commerce, Subcommittee on Oversight and Investigations. As indicated then, because of unresolved safety questions on the use of cloning technology to clone a human being, FDA will not permit such attempts. In 1998, FDA described its position in a widely circulated "Dear Colleague" letter.

In keeping with the provisions of its statutory responsibilities, FDAís role in these matters is limited to scientific, technical and regulatory considerations. However, as noted by the President as well as by the National Bioethics Advisory Commission, additional concerns beyond the scope of FDAís role remain to be resolved ¾ especially the broad social and ethical implications of cloning human beings, such as whether the use of human somatic cell nuclear transfer is morally acceptable under any circumstance.

COMMENTS ON PENDING LEGISLATIVE PROPOSALS

The Administration favors the passage of specific legislation to prohibit the cloning of a human being, including cloning techniques either to assist human reproduction or to develop cell- or tissue-based therapies. We look forward to working with the Congress to achieve this goal. For today, I present our comments on the Cloning Prohibition Act of 2001 (H.R. 2172, introduced by Mr. Greenwood) and the Human Cloning Prohibition Act of 2001 (H.R. 1644, introduced by Mr. Weldon), respectively.

H.R. 2172

H.R. 2172 focuses on preventing (a) the use of human somatic cell nuclear transfer (SCNT) technology to initiate a pregnancy or (b) the shipment or transportation of the product resulting from such technology if the product is intended to initiate a pregnancy. The bill does not restrict any other uses of human SCNT, such as creating human embryos for research purposes. This is a major concern to the Administration.

To foster enforcement of its provisions, the bill requires that an individual who intends to perform human SCNT register his/her name and place of business. This registration must include a statement or attestation, signed by the individual, declaring that he/she is aware of the prohibitions specified in the bill and will not engage in any activity that violates them. The registration requirement could cover a substantial number of academic and industrial laboratories.

The bill amends the Federal Food, Drug and Cosmetic Act to provide for criminal and civil penalties for any of the billís prohibited activities. Moreover, to protect the confidentiality of the information that will be collected as a result of the registration process, the bill requires that the Secretary not disclose any of this information unless the registrant has provided authorization in writing or the disclosure does not identify either the individual or his/her place of business.

H.R. 1644

H.R 1644 amends Title 18 of the U.S. Code to prohibit (a) performing or attempting to perform human cloning, (b) participating in an attempt to perform such activity, or (c) shipping, receiving, or importing the product of human cloning. To achieve these ends, the bill defines "human cloning" as follows:

"The term "human cloning" means human asexual reproduction, accomplished by introducing the nuclear material of a human somatic cell into a fertilized or unfertilized oocyte whose nucleus has been removed or inactivated to produce a living organism (at any stage of development) with a human or predominantly human genetic constitution."

As we interpret the bill, it prohibits not only the use of human somatic cell nuclear transfer to initiate a pregnancy but also all other applications of somatic cell nuclear transfer with human somatic cells, such as cloning to produce cell- and tissue-based therapies. This is consistent with Secretary Thompsonís and the Presidentís views.

Scientific research that is not specifically prohibited in the bill is unrestricted by it. Examples of research that are not prohibited are the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans. Penalties for violation of the billís prohibitions include at least $1 million in civil penalties and/or up to 10 years in prison.

We support this billís intent of banning human cloning, but believe that it warrants further review to resolve some technical issues.

CONCLUSION

HHS applauds the Committee for addressing the issues associated with cloning human beings and welcomes the initiative of Representatives Greenwood and Weldon in offering specific legislative proposals. We look forward to working with the Congress to prohibit morally offensive uses of cloning technology without stifling the development of important cell- and tissue-based therapies to combat human diseases.


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Last revised: September 24, 2001