Federal legislators sent the following letter to NIH director Harold Varmus in response to his proposal that the Recombinant DNA Advisory Committee be disbanded. June 26, 1996 Dr. Harold Varmus Director National Institutes of Health 9000 Rockville Pike, Building One Rockville, Maryland 20892 Dear Dr. Varmus: We are writing to express our concerns over the proposed abolition of the National Institutes of Health (NIH) Recombinant DNA Advisory Committee, known as the RAC. The tremendous progress in genetic research and the dramatic growth of the biotechnology industry in the past 20 years can be attributed significantly to the rigor, flexibility and credibility of this regulatory structure. Unlike many other developed countries, the United States has been exceptionally successful in maintaining an appropriate balance between academic freedom, commercial requirements and broad social considerations in our pursuit of knowledge and our search for new therapies. It is our concern that abolition of the RAC would be widely perceived both here and abroad as a step backward from this successful balance. According to your staff, there are two policy reasons for abolishing the RAC. We believe neither of them would outweigh the potential damage caused by such a step. Indeed, there are alternatives which would address your agency's concerns without jeopardizing a vital component of our country's oversight of genetic research. The first reason cited was the potential of RAC review to delay gene therapy research. Yet only a year ago, the NIH and the Food and Drug Administration (FDA) acted on the recommendations of the National Task Force on AIDS Drug Development and adopted an interagency "consolidated review" process to streamline the review of human gene transfer experiments. The consolidated review process ensures that only novel protocols are referred to the RAC for review. Today the vast majority of protocols are exempt from RAC review. Nor are we convinced that institutional review boards (IRBs) are capable of taking on the primary responsibility of reviewing novel gene therapy protocols. In March 1996, the General Accounting Office (GAO) issued a report titled, "Scientific Research: Continued Vigilance Critical to Protecting Human Subjects." The GAO concluded that "workload and other demands" currently "impair IRB oversight" of clinical trials. It is our concern that abolishing the RAC could abruptly add new and unfamiliar responsibilities to the workloads of IRBs across the country. …