Recombinant DNA Advisory Committee - 12/3-4/92 
Gene Transfer, is comprised of 40 individuals from Spain, France, Belgium, Holland, 
Germany, Italy, the United Kingdom, and Sweden. The first organizational meeting of 
this working group was held in October 1992; at that time, the president, officers, and 
board members were elected. 
Dr. D. Miller stated that a large body of information regarding the review process can be 
obtained from the Points to Consider and the RAC meeting minutes. Earlier discussion 
suggested that the request should not be honored unless it came from a regulatory 
authority. Dr. Blaese explained that an official request would not be made until the 
organizational structure has been established and the European members have attended 
RAC meetings. 
Dr. Carmen stated that as a political scientist, he sees a great deal of merit in acceding 
to this request. The RAC is advisory to the NIH Director. NIH is part of a Federal 
agency and it is our responsibility to offer expert views on recombinant DNA research, 
particularly human gene therapy. The RAC has been asked to provide advice and 
counsel the formulation of high policy in an area of great concern to the EC. Providing 
assistance would be a great step forward in cooperation between the U.S. and the EC. If 
the RAC establishes that this request has come from a duly constituted representative of 
the EC, then the RAC should provide its assistance. 
Dr. Seth Pauker of the FDA said that the EC has a committee that reviews proprietary 
medicinal products. This directive was established in 1987, and the committee has been 
responsible for the review of all biotechnology produced pharmaceuticals. This 
committee has a biotechnology working group that has established guidelines similar to 
the FDA's points to consider. Dr. Pauker said that is reasonable to suspect that the 
members of this committee have given this issue considerable thought. 
Dr. Dronamraju asked Dr. Wivel about NIH's policy regarding such issues. Dr. Wivel 
responded that there is nothing in the NIH Guidelines that would provide the RAC with 
this particular purview. Dr. Doi asked Dr. Blaese if the EC is interested in scientific 
feedback alone or the social and ethical input that the RAC members could provide. 
Dr. Blaese stated that it is his understanding that this committee wants advice on more 
than just the scientific aspects of these protocols. The European investigators involved 
are certainly capable of providing scientific review; they are interested in the broader 
analysis. 
Ms. Meyers said that she does not understand why this request has developed into such a 
contentious issue. Clearly, the RAC should cooperate with the rest of the world to 
obtain the global objectives of treating and curing disease. 
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Recombinant DNA Research, Volume 16 
