23 
Dr. Miller said FDA would be very disturbed if the document were issued, 
even in preliminary form, without first making some of the changes he 
requested since the current document "is grossly inaccurate." He said a 
perception already exists this version is the final version of the points 
to consider document; the magazine "Science" has indeed assumed incorrectly 
this version is the final document. Dr. Miller said: 
"I think that is an inaccurate representation and that's the kind of 
misinformation that is promulgated when corrections are net made and 
things are published prematurely." 
Mr. Mitchell said the points to consider document was first published to 
obtain public comment in the January 22, 1985, Federal Register . No indi- 
cation was given that this document was final. 
Dr. Gottesman said she thought two changes could be made immediately: the 
changes in footnote one and Dr. Miller's first suggestion (for item (5) 
of the Introduction) concerning FDA's jurisdiction. She said the other 
changes suogested by Dr. Miller would require further discussion. 
Dr. Walters said same of the modifications proposed by Dr. Miller had been 
discussed by the working group and a deliberate decision made not to 
accept them. Dr. Walters said he would not wish to incorporate Dr. Miller's 
preposed changes without the working group's knowledge or consent. He 
suggested the more substantive of Dr. Miller's modifications be sent to 
•the working group for reconsideration. 
Dr. Davis suggested the language concerning the purpose of germ line gene 
therapy be modified. 
Dr. Gottesman said language discussing the purpose of germ line gene therapy 
can be ambiguous depending on whether one is thinking of the adult or the 
embryo. She agreed this language might be clarified but felt further 
discussion was necessary; she could not agree to a quick modification. 
Mr. Mitchell agreed more discussion was required; he said RAC should avoid 
language which might cause confusion. 
Dr. Davis suggested the points to consider document be returned to the 
working group for reconsideration. 
Dr. Gottesman reiterated her suggestion that RAC approve the points to 
consider document as a working document with the two changes she had 
mentioned (i.e., in footnote one and in item (5) of the Introduction). 
Dr. Miller's other suggested modifications would be discussed at a future 
meeting of the working group. Dr. Gottesman said the points to consider 
document could be sent in the interim to investigators seeking guidance 
for proposal submission. 
[143] 
