The
Food and Drug Administration (FDA)
The
Recombinant DNA Advisory Committee (RAC)
The Food and Drug Administration (FDA)
The FDA claims jurisdiction over human cloning but the extent of its authority is unclear. By law the FDA must base its decisions on the safety and efficacy of a proposed product or practice and is prohibited from considering ethical or social factors.
During the 1998 Senate debate on cloning, one of the arguments for postponing legislative action was the FDA's assertion that they would use their authority to stop any attempts to create human clones.
The FDA's claim is based on the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Under these statutes, implementing FDA regulations, clinical research on the creation of a human being using cloning technology could proceed only when an investigational new drug (IND) application was in effect. Approval of such an application would require the investigators to demonstrate that human subjects involved in such experiments would not be exposed to "unreasonable and significant risk of illness or injury." The FDA indicated in 1998 that since major safety questions associated with human cloning remained, they would not permit any such project to proceed.
The FDA does have limited jurisdiction over inheritable genetic modification, since it must approve all proposals involving human gene transfer. However, universities, clinics, and private firms are not prohibited from most types of human genetic experimentation, including germline modification and cloning, if they use their own funds.
Recombinant DNA Advisory Committee (RAC)
The Recombinant DNA Advisory Committee (RAC) is an advisory body appointed by the Director of the National Institutes of Health. It is charged with review of human gene transfer experiments. In the late 1980s a Human Gene Therapy Subcommittee was established specifically to explore the social and ethical implications of somatic gene transfer studies. Approval of somatic cell studies had to be obtained by both the Subcommittee as well as the parent Committee. This Subcommittee was disbanded in the early 1990s after repeated complaints by research scientists that approval from both committees was redundant. The role of the RAC has since been further weakened and is presently unclear.
Food and Drug Administration:
- Home page
http://www.fda.gov/ - Center for Biologics Evaluation and Research, "Use of Cloning
Technology to Clone a Human Being"
http://www.fda.gov/cber/genetherapy/clone.htm - Public Health Service Act
http://www.fda.gov/opacom/laws/phsvcact/phsvcact.htm - Federal Food, Drug, and Cosmetic Act
http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
Recombinant DNA Advisory Committee
http://www4.od.nih.gov/oba/rac/aboutrdagt.htm
More Information
Analysis:
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Perspectives:
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Technologies:
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