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Centers of Excellence at the FDA: A Disease-Oriented Approach to Medical Product Development

Centers of Excellence at the FDA: A Disease-Oriented Approach to Medical Product Development

Centers of Excellence at the FDA:  A Disease-Oriented Approach to Medical Product Development

A Friends of Cancer Research (Friends) Senate Briefing on Opportunities for Cross-Center Coordination at the FDA to Reflect Current Patient Care

February 24, 2016 – 11:00am-12:00pm

US Capitol Visitors Center, SVC201-00 – Washington, DC

Event Summary:

Congress has not modernized FDA’s organizational structure for medical products since the 1970s. The existing regulatory framework has been defined by a “divide and conquer” approach to oversight; separate centers within FDA regulate three major categories of medical products: drugs, devices, and biologics.

In order to take advantage of today’s advancements in science, drug development, and patient treatment, the FDA’s structure needs reorganization to focus its resources and ensure the best outcomes for patients. Friends proposes enhancing coordination at the FDA based on specific diseases to reflect 21st Century science and modern medical care.

  • An hour-long briefing on Capitol Hill to discuss the challenges facing the current medical product approval process at the FDA and propose establishing Centers of Excellence at the agency, building on previous efforts to develop a more disease-oriented approach to product regulation that have demonstrated the positive effect of this type of organizational structure.
  • This briefing will allow stakeholders to discuss the advantages of establishing regular cross-center processes to also align with and support employee motivation for regulating and delivering safe and effective medical products to treat major diseases.
  • Friends is proposing three to four pilot areas, with the first focusing on oncology. Other pilots could be focused on the areas of Neurodegenerative, Cardiovascular, and Infectious Disease


  • Steve Galson, MD, MPH, Senior Vice President, Global Regulatory Affairs And Safety, Amgen Inc.
  • Ellen Sigal, PhD, Chair & Founder, Friends of Cancer Research
  • Mark McClellan, MD, PhD, Director, Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University
  • George D. Demetri, MD, Director, Ludwig Center at Harvard Medical School
  • Otis Brawley, MD, Chief Medical Officer and Vice President, American Cancer Society Cancer Action Network
  • Kate Rawson, Senior Editor, Prevision Policy (Moderator)