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Gene therapy protocols should not be subject to proprietary restraints during FDA review -- RAC subcmte.

Executive Summary

GENE THERAPY PROTOCOLS SHOULD NOT BE SUBJECT TO PROPRIETARY RESTRAINTS during FDA review, the National Institutes of Health Recombinant DNA Advisory Committee Ad Hoc Review Committee recommends in a report submitted to NIH Director Harold Varmus, MD, in September and published in the Nov. 15 Federal Register. The ad hoc group's recommendations will be discussed at a Dec. 4-5 meeting of the RAC at NIH. Chaired by Inder Verma, PhD, The Salk Institute, the ad hoc committee was convened to address oversight of gene transfer protocols in order to make recommendations to Varmus on the future operations of the RAC ("The Pink Sheet" Sept. 4, p. 5).

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