15 
Dr. Walters said the working group had included this section in the document 
in the hope of encouraging companies to take the patent route in protecting 
confidential information. This would permit greater public participation in 
review of human gene therapy proposals. 
Mr. Mitchell said the key issue is vhether the RAC and the working group would 
encourage public review of proposals. 
The sutworking group rejected Dr. Miller's fourteenth comment. 
Dr. Walters said Dr. Miller in his fifteenth point expressed concern that the 
interrogatory style of the document may be interpreted as strident or even 
adversarial . 
Dr. Gottesman did not think the document was perceived as strident or adversarial . 
Dr. Anderson said there is no more adversarial organization than the FDA; he 
also found it extraordinary that Dr. Miller would attempt to give advice on 
how not to be adversarial. 
[Executive .Secretary's Note: The modified version of the points to consider is 
appended to these minutes as Attachment VII.] 
Presentation to the RAC at the September 25, 1985, Meeting 
Dr. Walters then asked the subworking group to suggest the optimal manner to 
present this document to RAC at the September 23, 1985, meeting. He said he 
would prefer that RAC formally accept this document and come to closure. 
Dr. Gottesman suggested it might be useful to send to RAC a list of the 
modifications the sufcworking group introduced into the document at the September 20, 
1985, meeting; this list would show none of the subworking group's modifications 
were substantive. 
Dr. Anderson said the working group had received four comments on this version 
of the document: one set of comments was received from the working group's ad 
hoc advisor, Dr. Temin; the second set of comments was from Dr. Miller of the 
FDA; the third set of comments was from Mr. Lee Rogers on behalf of the Founda- 
tion on Economic Trends; and the fourth set of comments had been solicited from 
Dr. Myron Max Levine by Dr. Walters. The working group received only one set 
of comments frcm the general public — those of Mr. Rogers. In general, Mr. Rogers' 
carmen ts were supportive. 
Mr. Mitchell suggested Dr. Walters present to RAC a short history of the devel- 
opment of this document; this short history would then be part of the public 
record. 
Dr. Gottesman asked Dr. Walters to rsnind RAC that the points to consider are 
a working document vhich will not be incorporated into the NIH Guidelines. 
[344] 
