ICMS Announces FDA Audit
International Cell Medicine Society Announces FDA Audit
PORTLAND, OREGON – Wednesday, June 6, 2012. The International Cellular Medicine Society (ICMS), a professional medical association dedicated to patient safety through the strict evaluation of cell-based treatments and the rigorous oversight of medical facilities and clinics today announced that its Institutional Review Board was audited by the Food and Drug Administration. The ICMS welcomed this audit as part of it continuing effort to provide transparency and oversight to the emerging field of autologous regenerative and cell-based medicine.
The ICMS IRB, licensed by US Department of Health and Human Services and registered the Office for Human Research Protections, provides initial review of new studies proposed by physicians and researchers seeking to provide new treatments as part of the practice of medicine. The IRB has reviewed nearly two dozen study applications over the last 3 years from nearly a half dozen countries.
“We welcome the visit of the FDA.” says Ricardo Rodriguez, MD, president of the ICMS Board of Directors. “As a professional medical association, we share the FDA’s vision of enabling safe, effective cell-based therapies.”
David Audley, executive director of the ICMS, echoed Dr. Rodriquez’ comments, stating, “The ICMS is establishing guidelines and accreditation for cell-based medical treatments that fall outside the FDA’s mandate, and would otherwise go un-regulated. While we understand the FDA is seeking to narrow the definition of the practice of medicine, we believe that we are fundamentally aligned in our joint efforts to give patients safe and effective options, and we look forward to their input and recommendations.”
Audley went on to express concerns over the FDA’s recent activities with regard to point of care treatments, stating, “While we do not dispute their regulatory role, we are concerned that FDA is trying to exert an influence over the practice of medicine by establishing authority over what studies an IRB can approve. We welcome the opportunity to work hand in hand with the FDA. We also believe that it is critically important not to confuse autologous therapies that are delivered at the point of care (like in vitro fertilization) with allogeneic therapies that are meant to treat thousands of patients from a single lot.”
ABOUT THE ICMS
The ICMS is a 501(c)(3) nonprofit professional medical organization that is focused on the development of standards for the evaluation of point-of-care, cell-based therapeutics worldwide. With over 3,500 members from over 35 countries, the ICMS is a global leader in patient safety through strict evaluation of therapies and rigorous oversight of clinics and facilities providing cell-based medical therapies. The ICMS maintains an independent Institutional review Board and manages a comprehensive Treatment Registry that tracks patient outcomes. More information can be found at www.cellmedicinesociety.org.