Attachment III - Page 7 
The interrogative style of the document could be interpreted as 
strident or adversarial. Rationale not provided for many of the 
questions. Need a more explicative, collaborative approach like that 
embodied in FDA's draft "Points to Consider in the Production and 
Testing of New Drugs, and Biologicals . . . . " 
Miller 
Need risk assessment conference on the use of retroviruses as vectors 
in socnatic-ce 11 gene therapy. 
Goldberg 
Increase number of public representatives on the Working Group from 1 
to 3. Promote public discussion of risk assessment questions 
regarding retroviral vectors. 
Goldbe rg 
Working Group should explore how many private firms not falling under 
NIH Recombinant DNA Research Guidelines will become involved in gene 
therapy, report findings to the Congress and the public. 
Goldberg 
Since the RAC and its Working Group have not responded to all of the 
issues raised by the President's Commission, "it is premature to 
consider a review process for individual proposed human gene therapy 
protocols . " 
Caval ie ri 
[ 26 ] 
