FDA Report on Patient Participation in Medical Product Discussions

Patient Advocacy Community Perspective Heard, Understood, and Identified


Washington, DC (February 23, 2016) – The National Health Council (NHC) publicly thanks the Food and Drug Administration (FDA) for incorporating numerous recommendations from the patient advocacy community in its report on Patient Participation in Medical Product Discussions.

The NHC, as the united voice for people with chronic diseases and disabilities, has been a vocal proponent of greater patient involvement in regulatory decision making. Some of the NHC’s specific proposals highlighted in the report include

  • Creation of a systematic approach to consistently incorporate patient preferences into the regulatory decision-making process.
  • Increased transparency on how patient input is evaluated and incorporated into decision-making.
  • Creation of a defined mechanism for patient organizations to engage with FDA.
  • Creation of a patient data collection tool that systematically organizes issues by disease area and identifies topics to facilitate communications between patient organizations and the FDA.
  • Guidance on the appropriate parameters and regulatory/legal safe-harbor for drug sponsor engagement with patients and patient organizations during medical product development.
  • Increased public-private partnership and stakeholder forums. The National Health Council was identified in the report as an existing group doing work which FDA could leverage.

“There is growing acknowledgement that patients can have important roles in the development of new drugs and treatments beyond their traditionally more passive role as research subjects,” said NHC Chief Executive Officer Marc Boutin. “The incorporation of patient input related to the outcomes that are most meaningful to the ultimate end users of medical products will aid in our shared goal of delivering high-quality medical care to people with chronic diseases and disabilities. This report is the latest step in the Agency’s effort to create regular, meaningful, and predictable opportunities for patients to engage and to set expectations for the patient community regarding how those opportunities will ultimately inform FDA’s processes.”

According to the report, which was published on February 19, a cross-agency work group will continue to meet to discuss implementation activities. FDA will develop a comprehensive plan for implementation of the FDA Safety and Innovation Act Section 1137, outlining the approaches to increase patient involvement across FDA regulatory discussions.

Additional Information

Nancy Hughes, nhughes@nhcouncil.org, cell phone: 703-608-9709