Monday, February 3, 1997
WASHINGTON - An NIH-Department of Energy task force has formalized its proposals to institute government regulation genetic testing, compel FDA to regulate of genetic testing services, and establish a variety of new regulatory and advisory bodies to deal with genetic testing issues.
The Task Force on Genetic Testing, which was created by the NIH-Department of Energy Working Group on Ethical, Legal, and Social Implications of Human Genome Research, published its conclusions in the Federal Register last week. The proposed recommendations would fill in the current void in the regulation of genetic testing services with a plethora of new organizations.
The task force is soliciting public comment and is considering how to integrate dissenting views of its own members into final recommendations, which will be issued in March
Cost not included
New regulatory and advisory bodies envisioned by the task force include: an Advisory Committee on Genetics and Public Policy in the office of the Secretary of Health and Human Services; a National Genetics Board; an FDA Genetics Advisory Panel; a Genetics Advisory Committee to the Clinical Laboratory Improvement Advisory Committee (CLIAC); a National Coalition for Health Professional Education in Genetics; and