FDA appoints leaders for product innovation, safety group

The US Food and Drug Administration (FDA) has created the board of its new Reagan-Udall Foundation, taking the agency one step closer to its goal of enhancing the development and safety of food and food ingredients.

The US Food and Drug Administration (FDA) has created the board of its new Reagan-Udall Foundation, taking the agency one step closer to its goal of enhancing the development and safety of food and food ingredients. The non-profit group was founded on September 27, when the President signed into law the agency's Amendments Act of 2007 (FDAAA). As well as its activities in the food sector, the foundation will also aim to modernize product development and accelerate innovation in the medical, veterinary and cosmetics fields. According to FDA, the newly appointed board members - who come from backgrounds in science, academia and industry - will help the agency "bridge scientific discovery into the development of safe and effective products". The duties of the foundation will include the identification of unmet needs in the development, manufacture, and evaluation (including postmarket evaluation) of the safety and effectiveness of FDA-regulated products, and the establishment of scientific and other projects and programs to meet those needs. "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," said Dr Mark McClellan, who will chair the foundation. McClellan is the 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. The 14-member board is composed of: four representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries; three representatives of academic research organizations; two representatives of patient or consumer advocacy organizations; one representative of health care providers; and four at-large representatives with expertise or experience relevant to the purpose of the foundation. Nine board members were appointed from a list of candidates provided by the National Academy of Sciences. Five Board members were appointed from lists of candidates provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations. FDA said the board will oversee the organization's activities, approve programs and monitor their effectiveness, coordinate the groups' activities with federal research programs, award grants, and raise resources. "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 von Eschenbach, FDA 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." 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