The NICEATM-ICCVAM Five-Year Plan (2008-2012)

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The NICEATM-ICCVAM Five-Year Plan (2008-2012)

Neil Wilcox, Kimberly-Clark Corporation

Published: December 6, 2007

About the Author(s)
Dr. Neil Wilcox graduated with honors from Michigan State University’s School of Veterinary Medicine with a Doctor of Veterinary Medicine (DVM) and a Bachelor of Science in Biology. In addition, he is a graduate of the University of Michigan’s School of Public Health with a Masters of Public Health (MPH) in Public Health Policy and Administration. Dr. Wilcox brings unique leadership experience focusing on global regulatory compliance with formal education and experience in public health, clinical medicine, product safety, quality assurance and regulatory vigilance. His formal and experiential training transcend private practice in Veterinary Medicine, public service in the U.S Food & Drug Administration and leading change and organizational effectiveness in the personal care industry. He is currently accountable for global corporate regulatory product compliance, product safety, corporate quality and clinical testing for the Kimberly-Clark Corporation. Dr. Wilcox’s broad background is well suited to multiple dimensions of business management and leading organizational development and change. He established FDA’s first Office of Science for the Commissioner and successfully developed programs to coordinate science policy across the agency. As the recognized liaison for FDA science issues, Dr. Wilcox obtained extensive experience in establishing policy for federal regulatory agencies, non-profit organizations, and various international groups dedicated to public health and safety. He is a charter member of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). Since transitioning to the private sector, Dr. Wilcox has successfully developed and implemented strategies providing results-oriented approaches to ensuring product compliance, safety and quality on a global basis. Dr. Wilcox is a member of various trade and professional associations.

Neil L. Wilcox, DVM, MPH
Vice President, Global Regulatory & Scientific Affairs
Kimberly-Clark Corporation
Neenah, WI 54956
E-mail: neil.wilcox@kcc.com

Introduction

The ICCVAM Five-Year Plan is well written and adequately characterizes past activities. It describes four key challenges for ICCVAM over the next five years: “1) identify priority areas to conduct and facilitate activities in the areas of research, development, translation, validation, and regulatory acceptance of alternative methods; 2) research initiatives that are expected to support the future development of innovative alternative test methods; 3) foster the acceptance and appropriate use of alternative test methods through outreach and communication in order to reduce and replace animal use and improve animal welfare; and 4) develop partnerships and to strengthen interactions with ICCVAM stakeholders in order to facilitate meaningful progress. Moreover, the Plan’s priorities are intended to “emphasize alternatives for those test methods that involve significant animal pain and distress and that use large numbers of animals.”1 Although the challenges and priorities outlined cover many salient issues, the Plan fails to provide benchmarks, success metrics or deliverables, and it does not address ICCVAM governance or process. To this latter point, it is perceived that the process by which the ICCVAM standing committee, consisting of representatives from 15 participating federal agencies, was constituted is inconsistent with the original intent and basis upon which the committee was founded and is therefore flawed as it currently exists.

Background

ICCVAM was founded as a forum through which federal regulatory agencies could work to establish a standardized and conscientious approach to the broad arena of alternatives to animal testing. There was a genuine interest in establishing an interagency committee that would represent a credible and responsible attempt to promote the development, validation and acceptance of alternatives as defined under the notion of the 3Rs (Reduction, Refinement and Replacement). The agency representatives were not necessarily intended to be experts in toxicological testing or any other specific discipline. Instead, they were to be knowledgeable in the requirements of animal testing, understand issues as related to alternatives and act as liaisons to their agencies. Once a process for the review of qualified test methods for validation had been established, the role of the ICCVAM committee was well defined. That is, the 15 member ICCVAM committee was charged with acting as an advocate for the test method’s sponsor.

To this end, it was the responsibility of the ICCVAM committee to ensure that the sponsor of the proposed test method had met the “General Guidelines for Submissions to ICCVAM.”2 In this capacity, it was the responsibility of the ICCVAM committee to facilitate the preparation of the dossier intended to provide the requisite information to substantiate the validation of the proposed test method as defined by its conditions of use. The decision was made early in the development of the ICCVAM process that it was impractical to establish an ICCVAM committee of experts for any and all types of methods that may be submitted for validation. Instead it was determined that the ICCVAM committee would establish ad hoc panels of experts to review the submissions to ensure the data generated by the sponsor adequately supported the test method. Finally, a Federal Advisory Committee would then be established consisting of subject matter experts, providing an independent scientific review, to determine if the test method was validated for its intended use. Of course, regulatory acceptance of a validated method was the decision of the individual agencies participating in the ICCVAM process.

The ICCVAM Process

At present time, there is a perception that the ICCVAM committee has taken on a role that is a departure from the original intent. Today, the ICCVAM committee no longer acts as an advocate for the sponsor, where its primary role was to ensure that the sponsor’s submission was complete and met the requirements as established by the Guidelines. Instead, it reviews the sponsor’s submission and determines if the proposed method rises to the level of interest of its member agencies and if the data substantively support validation. If these two criteria are met, an expert review committee (Federal Advisory Committee) is established to determine if the ICCVAM recommendation is substantiated. This is a significant departure from the original intent of the ICCVAM process. Although there is an expressed desire to provide transparency in this process, there is little transparency in the day-to-day deliberations of the ICCVAM committee leading to its recommendation on a particular submission. Moreover, the ICCVAM process is a departure from sound scientific principals in that the members have taken on the responsibility of reviewing data for which they are not qualified. As stated earlier, expert credentials are neither a requirement of ICCVAM committee member participation nor is it a practical expectation. There are no standardized requirements for ICCVAM membership status and there are no term limits. Finally, a Federal Advisory Committee is convened to review the recommendation for validation rather than review a submission as an independent body to determine the validity of a model based upon its scientific merit as it relates to its intended use.

Conclusions

The “Review of the Draft NICEATM-ICCVAM Five-Year Plan” by the SACATM Working group for the NICEATM-ICCVAM Five-Year Plan (FYPWG), is an excellent review of the Plan and raises many questions that illustrate important gaps in the document. I strongly agree with the FYPWG report and would suggest that there are two important opportunities for improvement. Firstly, as described above, the ICCVAM process needs to be revised to ensure transparency, expert and independent scientific review, standardized credentials for ICCVAM membership, term limits and standard operating principles that provide checks and balances to prevent conflicts of interest. And secondly, the Plan is clearly deficient in defining a clear strategy with goals, objectives, tasks and deliverables. Without well established milestones, time-lines and success metrics, there can be no measure as to the success of the Plan at the completion of the five-year period.
©2007 Neil Wilcox

References
1 Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), “The NICEATM-ICCVAM Five-Year Plan (2008-2012)” Draft: May 2007, page 3.

2 Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), “Evaluation of the Validation Status of Toxicological Methods: General Guidelines for Submissions to ICCVAM.” March, 1997; Revised October, 1999.