FDA not included in PCORI

September 28, 2010
Ronald Piana

The regulatory agency isn’t represented on the board of governors of the new Patient Centered Outcomes Research Institute.

As noted in the RPM Report, the membership of the Patient Centered Outcome Research Institute board is set, and FDA is not included.

That isn’t especially surprising; the board (mandated by the health care reform law) was deliberated set up as a primarily private sector member base, with two government officials (National Institutes of Health Director Francis Collins and Agency for Healthcare Research & Quality Administrator Carolyn Clancy) identified in statute as members.

The other 17 members were selected by the Government Accountability Office, following a relatively rigid set of categories imposed in the law. The goal is to ensure representation from a broad set of stakeholders, including surgeons, nurses, health plans, integrated health delivery systems, hospitals, patients, consumers, medical device companies, biopharma companies and diagnostic companies.

Under the statutory menu, there is only one guaranteed slot for another federal government member, and only two guaranteed government slots (state and federal) overall. It seemed clear all along that one of those slots would go to the Department of Veterans Affairs, which-after all-is a very large stakeholder in CER.
Still, given the importance of comparative effectiveness research within the health policy sector, it isn’t surprising that FDA would want to be part of the team.

Below is the list of board members:

Members of the Board will be appointed for a six-year term and may be reappointed for one subsequent six-year term.
The terms of the PCORI board members are staggered, with the first set of appointments made in September 2010 set at two, four, and six years.

Commissioners whose first term will expire in September 2016 are:
o Eugene Washington, MD, MSc, Vice Chancellor, UCLA Health Sciences, and Dean, David Geffen School of Medicine, University of California Los Angeles. Dr. Washington will serve as the chair of the PCORI Board of Governors.
o Steven Lipstein, MHA, President and Chief Executive Officer, BJC Health Care, a non-profit health care delivery system. Mr. Lipstein will serve as the vice chair of the PCORI Board of Governors.
o Christine Goertz, DC, PhD, Vice Chancellor for Research and Health Policy, Palmer College of Chiropractic and Palmer Center for Chiropractic Research.
o Sharon Levine, MD, Associate Executive Director for The Permanente Medical Group of Northern California, a large multi-specialty group practice within Kaiser Permanente’s integrated delivery system.
o Ellen Sigal, PhD, Chairperson and founder of Friends of Cancer Research, a cancer research think tank and advocacy organization.
o Harlan Weisman, MD, Chief Science and Technology Officer, Medical Devices and Diagnostics, for Johnson & Johnson.
o Robert Zwolak, MD, PhD, a vascular surgeon at Dartmouth-Hitchcock Medical Center and professor of surgery at the Dartmouth Medical School.
Commissioners whose first term will expire in September 2014 are:
o Lawrence Becker, Director, Strategic Partnerships and Alliances, Xerox Corporation.
o Arnold Epstein, MD, the John H. Foster Professor and Chair of the Department of Health Policy and Management at Harvard University School of Public Health, and practicing internist at Brigham and Women’s Hospital.
o Andrew Imparato, JD, President and Chief Executive Officer of the American Association of People with Disabilities.
o Robert Jesse, MD, PhD, Principal Deputy Under Secretary for Health and National Program Director for Cardiology, Department of Veterans Affairs.
o Freda Lewis-Hall, MD, Chief Medical Officer and Senior Vice President of the Pfizer Medical Division.
o Grayson Norquist, MD, MSPH, Professor and Chairman, Department of Psychiatry and Human Behavior, University of Mississippi Medical Center.

Commissioners whose first term will expire in September 2012 are:
o Debra Barksdale, PhD, RN, Associate Professor, University of North Carolina (UNC) at Chapel Hill School of Nursing.
o Kerry Barnett, JD, Executive Vice President of Corporate Services and Chief Legal Officer, The Regence Group.
o Allen Douma, MD, Chief Executive Officer of Empower, LLC, and a member of the AARP Board of Directors.
o Leah Hole-Curry, JD, Program Director for the Health Technology Assessment (HTA) program, Washington State Health Care Authority.
o Harlan Krumholz, MD, Harold H. Hines, Jr. Professor of Medicine and Epidemiology and Public Health at Yale University School of Medicine.
o Richard E. Kuntz, MD, Senior Vice President and Chief Scientific, Clinical, and Regulatory Officer of Medtronic, Inc.