ICMS Announces FDA Audit Findings

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www.cellmedicinesociety.org

Cell Medicine Society Announces Initials Findings from FDA Audit

PORTLAND, OREGON. June 19, 2012. The International Cellular Medicine Society (ICMS), a global professional medical association dedicated to patient safety through the strict evaluation of cell-based treatments and the rigorous oversight of medical facilities and clinics, announced today the conclusion and initial findings from the audit of its Institutional Review Board (IRB) by the Food and Drug Administration (FDA). The ICMS is dedicated to increasing the safety and transparency of cell-based therapeutics.  In particular, the society has focused on establishing standards and guidelines for studies that fall outside the jurisdiction of the FDA.  This includes stem cell clinics outside the U.S. and clinics within the United States performing studies that fall under the definition of the practice of medicine.

In addition to providing standards and guidelines to help physicians develop safer, more transparent treatment regimes, the ICMS maintains an IRB to assess the ethical considerations of proposed studies.  This IRB, registered by the Office for Human Research Protections (OHRP), is comprised of a variety of scientific and medical experts and interested community members who share the ICMS’ dedication of increasing the safety and transparency of cell-based treatments.

The audit was conducted by the FDA to review the policies and procedures of the IRB and the protocols reviewed by the board over the last three years. Over the last three weeks, agents from the FDA reviewed nearly 25 protocols submitted by physicians who sought ethical review of treatments provided as the practice of medicine before delivering their initial findings and suggestions. The ICMS welcomed input from the FDA, and shares the FDA’s vision to provide more transparent and safer stem cell therapies.

The primary focus of the audit was to determine the status and approval policy for the study presented by the Multiple Sclerosis Research Center of New York (MSCRNY) which proposed to utilize bone marrow derived progenitor cells as a treatment for MS. The ICMS required that the MSCRNY obtain a legal opinion that the treatment was considered practice of medicine in the State of New York prior to its review. Once this opinion was provided to the MSCRNY, the study was reviewed and provisionally approved in October 2011 and then again in February of 2012. The study was declared inactive by the ICMS IRB in May 2012 pending official notice of the recruitment of the first patients by the MSCRNY.

“We decided to review this study because we believed that it is the practice of medicine in New York, and fell outside of federal regulations.” says David Harshfield, Jr., MD, chair of the ICMS IRB. The FDA has now claimed jurisdiction over this study. “It is important to note,” continued Harshfield, “that the FDA made no negative comment about our review or approval of the MS study, only about the ‘jurisdiction’.”

The findings of the audit (which will be published on the ICMS website within the next day) were delivered to the ICMS via a 483 Inspectional Observation Form which detailed the following areas of concern:

* Use of electronic signatures: With permission, the ICMS currently applies the electronic signature of the IRB chair. The FDA has requested that the Chair undertake this activity personally.

* Additional data on membership and voting records: The FDA has requested that rosters reflect the specific roles and skills of each member of the IRB, as well of those individuals who are members of the ICMS. Additionally, the FDA has requested that the IRB expand its minutes to reflect the vote of each member individually, as well as any abstentions and reclusions due to conflicts of interest.

* Minutes and SOPs: The FDA has requested that the IRB expand its minutes to provide greater detail on the nature of the reviews and the deliberations, as well as modify its standard operating procedures (SOPs) to reflect notifications for annual reviews, expressly detail the length of approval for any study and develop a process of dealing with minutes that must be edited or revised after approval.

David Audley, the executive director of the ICMS, expressed his satisfaction with the outcome of the audit, “While we have not yet received the final report from the FDA, we are very pleased with their initial conclusions.” stated Audley. “The FDA’s comments were limited to relatively minor issues such as increasing the level of detail in meeting minutes and providing a clearer explanation of the relationship of reviewers to the ICMS. We expect to be fully compliant with the recommendations of the FDA by August 1, 2012.”

Audley continued to say that he believed this audit would strengthen the ICMS’ IRB and increase the credibility of its review.  “While we clearly disagree with the FDA on the definition of the practice of medicine, we believe it is critically important to work with both state and federal agencies to increase transparency and increase safety.  We believe that working with the FDA will provide a stronger IRB, which is a service to both the clinician and the patient.”

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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.

Attachments:
Download this file (FDA 483 - ICMS IRB - 19 June 2012 (redacted).pdf)FDA 483 - ICMS IRB [ ]1374 Kb
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