FDA Announces Board Members of Reagan-Udall Foundation

The U.S. Food and Drug Administration (FDA) today announced the board members and chair of the Reagan-Udall Foundation. The private and independent nonprofit organization will advance FDA’s mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

“The Reagan-Udall Foundation will be an important and independent vehicle for furthering the mission of FDA. By supporting public-private partnerships and other scientific collaborations, the foundation will enrich the agency and provide critical perspectives for the future,” said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. “As FDA looks toward its future, the Reagan-Udall Foundation is in a unique position to understand, support and prepare the agency for that future.”

“This foundation brings together an extraordinary group of leaders with diverse talents and experiences. The board members’ combined backgrounds reflect the transformation and vision of FDA,” said von Eschenbach.

In a demonstration of bipartisan support, the U.S. Congress mandated the foundation’s creation in the Food and Drug Administration Amendments Act, passed in September 2007. The law requires that the foundation board of directors be established within 30 days and that it not include any federal employee.

Mark McClellan, M.D., Ph.D., director of the Engleberg Center for Health Care Reform at the Brookings Institution, former commissioner of FDA and former administrator of the Centers for Medicare and Medicaid Services, will chair the foundation.

McClellan said, “The foundation is an unprecedented opportunity to enlist broad-based support to accelerate scientific progress to help FDA fulfill its mission of protecting and promoting the public health—a mission that is more challenging but more important than ever.”

“I look forward to a collaborative partnership with the board, the agency, legislators, and stakeholders to accelerate innovation that will improve the quality and safety of medical and food products,” said McClellan.

In addition to McClellan, the new board members are:

* Georges C. Benjamin, M.D.
Executive Director, American Public Health Association
* William Brody
President, The Johns Hopkins University
* Helen Darling
President, National Business Group on Health
* Cal Dooley
President and CEO, Grocery Manufacturers Association
* Michael Doyle, Ph.D.
Regents Professor and Director, Center for Food Safety, University of Georgia
* Joseph M. Hogan
President and CEO, GE Healthcare
* Kay Holcombe
Senior Health Policy Advisory, Genzyme Corporation
* Sharon Levine, M.D.
Associate Executive Medical Director, The Permanente Medical Group
* Gary Neil, M.D.
Group President, Johnson & Johnson Pharmaceutical Research & Development
* Phillip A. Sharp, Ph.D.
Institute Professor, Center for Cancer Research, Massachusetts Institute of Technology
* Ellen V. Sigal, Ph.D.
Chair and Founder, Friends of Cancer Research
* Tadataka Yamada, M.D.
President, Global Health Program, Bill & Melinda Gates Foundation
* Diana Zuckerman, Ph.D.
President, National Research Center for Women and Families

“By agreeing to serve on the board, these distinguished representatives will help FDA continue to bridge scientific discovery into the development of safe and effective products,” said von Eschenbach. “They reflect the areas served by FDA, all of which have a stake in a transparent and collaborative process. The broad representation from science, academia and industry in addition to strong Congressional support for this foundation is indicative of its mission, which will be about building the science of product safety.”

The statute calls for a 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic, and biotechnology industries; three from academic research organizations; two from patient or consumer advocacy groups; one representing health care providers; and four at-large representatives with expertise or experience relevant to the foundation’s purpose.

In addition, a majority of the foundation’s board members—nine out of 14—must be appointed from a list of candidates provided by the National Academy of Sciences and the remaining five from nominations submitted by patient and consumer advocacy groups, professional scientific and medical societies and industry trade organizations.

As required by statute, four government health care officials—the commissioner of the FDA, the director of the National Institutes of Health, the director of the Centers for Disease Control and Prevention, and the director of the Agency for Health Care Research and Quality—appointed the board members from the two lists of candidates. The FDA commissioner and NIH director will continue participating in foundation activities as non-voting board members.

Congress established the Reagan-Udall Foundation to identify and address unmet scientific needs in the development, manufacture and evaluation of the safety and effectiveness of FDA-regulated products, including post-market evaluation. The foundation will establish scientific projects and programs to address those needs and help accomplish the scientific work FDA needs to support its regulatory mission.