Recombinant DNA Advisory Committee- 9/12-13/94 
Dr. Wivel (Executive Secretary) said in response to a question by Dr. Parkman that the 
NIH/FDA consolidated review and the ad hoc committee to review RAC activities are 
two different proposals. The streamlined review will be implemented while the ad hoc 
review will be planned for the future. Dr. Wivel explained the background and the 
revised review process. On July 18-19, 1994, the National Task Force on AIDS Drug 
Development held an open meeting for the purpose of identifying barriers to AIDS drug 
development that included a proposal to streamline the dual review process for human 
gene transfer experiments. One of the problems the AIDS investigators identified was 
that the RAC and FDA require different formats for their submission of applications for 
review. To streamline this process, one-stop "shopping" mechanism was proposed. Dr. 
Varmus, the NIH Director, and Dr. David Kessler, the FDA Commissioner, expressed 
their support for streamlining the review process as did Dr. Philip Lee, Chair of the AIDS 
Task Force and DHHS Assistant Secretary for Health. As a result of the Task Force’s 
deliberations, recommendations were adopted in order to eliminate any unnecessary 
overlap between FDA and NIH review of human gene transfer proposals. Both Drs. 
Varmus and Kessler noted that their respective agencies would cooperate fully to effect 
the changes necessary to implement these recommendations. The recommendations of 
the Task Force were: 
"The NIH and FDA recommend that the RAC become advisory to both the NIH 
Director and the FDA Commissioner with regard to the review of human gene 
transfer protocols. In the interest of maximizing the resources of both agencies and 
in simplifying the method and period of review of research protocols involving 
human gene transfer, it is planned that the FDA and the NIH institute a new 
consolidated review process that incorporates the following principal elements: 
"(1) All gene transfer protocols shall be submitted directly to the FDA. 
Submission will be in the format required by the FDA and the same format 
will be used by the RAC when public review is deemed necessary. 
"(2) Upon receipt, FDA review will proceed. The NIH Office of Recombinant 
DNA Activities (ORDA) staff will simultaneously evaluate the protocol for 
possible RAC review. 
"(3) Factors which may contribute to the need for RAC review include: (i) novel 
approaches, (ii) new diseases, (iii) unique applications of gene transfer, and 
(iv) other issues that require further public review. 
"(4) Whenever possible, principal investigators will be notified within 15 working 
days following receipt of the submission whether RAC review will be 
required. (RAC reviewed applications will be forwarded to reviewers 8 
weeks prior to the next quarterly RAC meeting.) 
"(5) Semi-annual data reporting procedures will remain the responsibility of 
NIH/ORDA. Semi-annual data reports will be reviewed by the RAC in a 
public forum." 
Recombinant DNA Research, Volume 20 
[45] 
