Food and Drug Administration’s (FDA) Framework for a Real-World Evidence Program; Availability


The National Health Council (NHC) is pleased to provide comments on the Food and Drug Administration’s (FDA) solicitation for feedback on FDA’s framework for a Real-World Evidence (RWE) Program, and appreciates the opportunity to provide input on this important topic. We fully support FDA’s multifaceted approach to implementing its RWE program.

Founded in 1920, the NHC is the only organization that brings together all segments of the health community to provide a united voice for the more than 160 million people in the United States with chronic diseases and disabilities, and their family caregivers. Made up of more than 125 diverse national health-related organizations and businesses, the NHC’s core membership includes the nation’s leading patient advocacy organizations, which control its governance and policy-making process. Other members include professional and membership associations; nonprofit organizations with an interest in health; and representatives from the pharmaceutical, generic drug, health insurance, device, and biotechnology industries.

The NHC supports the FDA’s efforts to develop a framework that aims to support the evaluation of RWE for potential use in regulatory decision making. The NHC has actively engaged with the FDA and other stakeholders over the past several years to help ensure that the patient voice is meaningfully incorporated. On July 31, 2017, the NHC convened a multi-stakeholder roundtable aimed at gathering patient-community views on RWE. From this workshop, key themes and approaches to increase the patient uptake, co-development, and application of RWE emerged, which are captured in our recently published manuscript, Patient‑Community Perspectives on Real‑World Evidence: Enhancing Engagement, Understanding, and Trust.
Findings include:

  • Common definitions for real-world data (RWD) and RWE are vital;
  • Acceptable uses of RWE are context specific;
  • Partnerships between patient groups and the scientific community support high-quality RWE; and
  • Authentic sources of patient-provided data, including patient-generated data (e.g., patient-organization registries), should be considered.

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