Recombinant DNA Advisory Committee- 9/12-13/94 
of the new system after it is implemented. 
Dr. Straus said that the RAC is eager to see this conceptual process move forward. He 
was not sure what is to be voted on since the administrative decision to implement this 
new system was already made, and Dr. Varmus has proposed the formation of an ad hoc 
committee to review RAC activities. Mr. Capron explained that the thrust of the motion 
is to endorse the revised FDA proposal presented by Dr. Noguchi to keep the Points to 
Consider under the NIH Guidelines and to disapprove the proposed deletion of this 
document from the NIH Guidelines, as announced in the Federal Register on August 23, 
1994. Mr. Capron would vote for Dr. Miller’s motion, but he agreed with Dr. Straus’ 
assessment that the major action will come from Dr. Varmus’ proposed ad hoc committee. 
Dr. Walters said the RAC is endorsing the concept and will pass the endorsement to the 
ad hoc committee. 
Mr. Capron said that under the new system, only those essentially repetitive experiments 
will be exempt from RAC review. Most AIDS gene therapy protocols represent new 
approaches and will continue to have full RAC review. The proponents of the new review 
system in the National AIDS Task Force may not be terribly satisfied. All the submitted 
Points to Consider will be filed at ORDA, and the master list of all the approved protocols 
and data reporting will be maintained as a public record. 
Dr. Parkman commented that Dr. Varmus had touched on two important issues: (1) the 
global philosophical question of what are the pertinent RAC activities; and (2) to refine 
the review criteria and establish consistency in applying these criteria to the review of 
each protocol. Dr. Wivel said that the elements that define RAC review have been 
deliberately left loose enough so that they provide guidance rather than restriction. The 
whole process is contingent on a case-by-case review with a flexibility inherent in this type 
of approach. Dr. Walters remarked that Dr. Varmus’ proposal for ad hoc review 
originated from his recent review of a RAC recommendation regarding the Curiel 
protocol, and it is independent from the NIH/FDA consolidated review proposed at the 
AIDS Task Force meeting. Dr. Parkman agreed that the expected criteria for RAC 
approval such as preclinical data are not clearly defined in the Points to Consider , and 
what Dr. Varmus has suggested is to define these criteria more closely in dealing with 
different kind of diseases. 
Dr. Walters called for a vote on Dr. Miller’s motion. Dr. Wivel stressed that the motion 
will nullify the proposed deletion of the Appendix M from the NIH Guidelines. Mr. 
Capron said that retention of Appendix M is stated in Dr. Noguchi’s proposal, and the 
motion is to approve this proposal. Dr. Noguchi remarked that the last element of his 
proposal is to form a working group to propose long-term consolidation, and this element 
possibly can be combined with the ad hoc committee proposed by Dr. Varmus. Mr. 
Capron pointed out that Dr. Varmus’ proposal is an "external review" of RAC activities, 
and it is a prerogative for a NIH Director to perform this kind of review. The vote to 
endorse the FDA proposal is to endorse the concept and the direction of the NIH/FDA 
consolidated review. Dr. Chase said that the minutes will reflect deliberation of the intent 
of the motion that Appendix M will not be deleted from the NIH Guidelines , and the 
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