Abstract
The National Institutes of Health (NIH), while having no legal mandate to regulate developments in genetic engineering, have influenced the field through the review activities of their Recombinant DNA Advisory Committee (RAC). Recent challenges to RAC's prestige and authority have emerged from within the Department of Health and Human Services. A proposed Biotechnology Science Board, under the Assistant Secretary for Health, would exercise broad authority over biotechnology research, including clinical trials of human gene therapy. Food and Drug Administration officials have also expressed a strong interest in reviewing these research protocols, which NIH considered within its purview. As a result of this political maneuvering, publication of NIH's revised gene therapy guidelines has been delayed, and RAC may find itself functioning solely as an in-house advisory body to NIH.
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