WASHINGTON, DC -- (Marketwired) -- 05/22/14 -- The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the advanced therapies and regenerative medicine community, supports the NIH decision announced today to change the oversight role of the Recombinant DNA Advisory Committee (RAC).
ARM developed a policy paper last month outlining recommendations for adjustments to the RAC in light of dramatic changes in gene therapy since the RAC's creation over 40 years ago.
"We support the NIH's recommendations to change the role of the RAC," said Michael Werner, Executive Director of ARM. "The RAC is best suited to focus on novel technologies and to convene broad public discussions, and that will be its focus under the NIH proposal. We look forward to working with NIH as it implements this new policy."
ARM's paper notes the RAC was originally formed in the 1970s due to the novelty of gene transfer and concerns about public acceptance and understanding of the technology. During the past 40 years, gene therapy research and clinical development have become increasingly more prevalent. There are currently 207 open gene transfer trials listed on clinicaltrials.gov, most of them using technologies that are "non-novel" (e.g. LLV, gamma retro, AAVs, non-viral plasmid). In many ways, the RAC's role to provide oversight at a national level for non-novel gene therapy products is redundant with the FDA's oversight of gene and cell therapy products, and additional supportive review from the RAC is not needed. ARM's view is consistent with an Institute of Medicine report on the RAC published in December, 2013.
About the Alliance for Regenerative Medicine:
The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 150 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit www.alliancerm.org.