The New RAC: Restructuring of the National Institutes of Health Recombiant DNA Advisory Committee 54 Food and Drug Law Journal 1999

54 Food & Drug L.J. 49 (1999)
The New RAC: Restructuring of the National Institutes of Health Recombiant DNA Advisory Committee

handle is hein.journals/foodlj54 and id is 87 raw text is: The New RAC: Restructuring of the National Institutes
of Health Recombinant DNA Advisory Committee
JUDITH E. BEACH, PH.D. *
I. INTRODUCTION
The National Institutes of Health (NIH) Recombinant DNA Advisory Committee
(RAG) was established October 7, 1974, in response to public concerns regarding the
safety of manipulation of genetic material through the use of recombinant deoxyribo-
nucleic acid (DNA) techniques. The goal of the RAC is to consider the current state of
knowledge and technology regarding DNA recombinants, their survival in nature,
and transferability to other organisms, and to recommend guidelines for the conduct
of recombinant DNA experiments.' This article attempts briefly to recount the major
changes to the RAC and their effects on the procedures for submission of human gene
transfer protocols.
Recently, the RAC has been undergoing major restructuring. RAC membership,
which includes scientists, lawyers, ethicists, and consumers, has been reduced from
twenty-five to fifteen.2 Though the RAC has retained its role as a public forum for
discussion of issues relating to research proposals involving the deliberate transfer of
recombinant DNA, or DNA or RNA derived from recombinant DNA, into human
subjects (human gene transfer), it has relinquished its previous responsibility for ap-
proving specific human gene transfer protocols.3 Thus, the RAC no longer votes to
approve or block protocols; all approval responsibilities for recombinant DNA experi-
ments involving gene transfer lie with the Food and Drug Administration (FDA),
which retains statutory authority for such approval.4 The RAC continues to meet to
discuss and make recommendations for gene therapy protocols determined by at least
three RAC members to be novel or controversial enough to justify public discourse.5
One significant component of the restructuring of the RAC was the establishment
of Gene Transfer Policy Conferences (GTPCs), also administered by NIH's Office of
Recombinant DNA Activities (NIH/ORDA).6 These conferences assemble numerous
participants possessing scientific, ethical, and legal experience, and/or interest appli-
cable to recombinant DNA issues.7 Each GTPC is devoted to a single issue, relevant to
scientific or safety issues, relating to research on the use of novel gene delivery ve-
hicles, and applications to human gene therapy, novel applications of gene transfer, or
irrelevant ethical and social implications of a particular application of gene transfer
technology. The findings and recommendations of each GTPC are public, and are
made available to FDA, the Office for Protection from Research Risks (OPRR), and
other components of the Department of Health and Human Services (DHHS).
In addition, public accountability for human gene therapy research continues to
* Dr. Beach is Associate General Counsel, Regulatory Affairs, Quintiles Transnational Corp., Research
Triangle Park, NC.
I Nat'l Inst. of Health, Office of Recombinant DNA Activities (ORDA), Recombinant DNA Advisory
Committee Charter (visited Feb. 12, 1999) <www.nih/gov/od/orda/charter.htm>.
262 Fed. Reg. 4782 (Jan. 31, 1997).
362 Fed. Reg. 59,032 (Oct. 31, 1997).
'Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, § 505, 52 Stat. 1040, 1052 (1938) (codified
as amended at 21 U.S.C. § 355 (1994)); 21 C.F.R. pt. 312 (1998).
'62 Fed. Reg. at 4783.
6See infra note 9, app. L.
7Id.

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