11 
Dr. Mary Ann Danello of the FDA said she was speaking for Dr. Henry Miller 
of the FDA. She asked that canments submitted by Dr. Miller on 
Septerrber 13, 1985 (tab 1243), be reconsidered especially his points 
four, five, six, and twelve. 
Dr. Walters said these four points were originally offered in Dr. Miller's 
February 20, 1985, letter commenting on the January 22, 1985, Federal 
Register announcement. Those canments were fully discussed at the 
April 1, 1985, meeting of the working group. Comment six was accepted by 
the working group at that time and the points to consider document modified. 
On April 1, 1985, a majority of the working group decided not to accept 
suggestions four, five, and twelve. Dr. Miller again offered these canments 
in response to the August 19, 1985, Federal Register . The subworking 
group again considered these canments on September 20, 1985, and rejected 
them. Dr. Walters said the working group fairly considered all the issues 
raised in the comment letters. 
Mr. Jeremy Rifkin of the Foundation on Economic Trends tharked Dr. Waiters 
and the working group for the consideration shewn to the concerns expressed 
by the Foundation on Economic Trends. 
Mr. Rifkin said the points to consider document demonstrates careful consid- 
eration and thought and contains a great dead, of technical detail? however, 
"short shrift" was given to social issues. He thought the points to consider 
lack guidance for evaluating ethical and social issues. He suggested 
society should begin to wrestle with social and ethical questions with the 
same degree of careful consideration given to technical issues. He said 
"not to do so would be to shew a lack of responsibility for the tremendous 
weight of this technology." 
Mr. Rifkin said "it is not too early to ask some long-term questions and to 
develop seme protocols about the eugenic implications " of gene therapy. 
He contended that failure to address ethical and social issues associated 
with germ line modification and the relationship between somatic-cell 
and germ line therapy will delay the review process. He drev an analogy 
to field testing of modified organisms. Mr. Rifkin said appropriate, review 
protocols had not been prepared by the RAC Working Group on Release into the 
Environment and RAC was "ill-equipped" during the first reviews to "ask 
the appropriate questions. As a result, there's been in a two year delay 
in deliberate release." 
Mr. Rifkin said criteria should be established for determining what types 
of somatic-cell therapy would not be permissible. He thought language in 
the Federal Register announcement implies "that erihandve gene therapy 
would only ccme up in germ line experiments which is not really true." 
[393] 
