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Real-World Evidence in the Real World: Beyond the FDA.

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  • 1Dan K. Moore Distinguished Professor, UNC School of Law; Professor (Secondary Appointment), Social Medicine, UNC School of Medicine; Adjunct Professor, Health Policy & Management, UNC Gillings School of Global Public Health. I thank Lenore R. Livingston for her research assistance.

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Real-world evidence (RWE) shows promise for improving healthcare, but its widespread impact is likely overstated. Challenges like data reliability and regulatory oversight hinder its integration beyond FDA approvals.

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Area of Science:

  • Health Policy
  • Regulatory Science
  • Data Science

Background:

  • The 21st Century Cures Act promotes real-world evidence (RWE) for Food and Drug Administration (FDA) approvals.
  • Interest in RWE is expanding beyond regulatory applications.
  • RWE offers pragmatic benefits but faces significant implementation hurdles.

Purpose of the Study:

  • To critically evaluate the overstated claims surrounding RWE's broad impact on the healthcare system.
  • To identify obstacles and limitations in applying RWE beyond FDA decision-making.
  • To examine potential implications of RWE adoption on healthcare fraud and abuse laws.

Main Methods:

  • Literature review and critical analysis of RWE applications.
  • Examination of data reliability and stakeholder incentives.
  • Assessment of regulatory oversight gaps for RWE.

Main Results:

  • Claims of RWE's wide-ranging benefits are likely exaggerated.
  • Significant challenges exist in integrating RWE into healthcare decision-making.
  • Concerns include data quality, stakeholder engagement, and regulatory frameworks.

Conclusions:

  • The practical application of RWE beyond FDA regulation faces substantial obstacles.
  • Increased reliance on RWE may complicate healthcare fraud and abuse law enforcement, particularly concerning off-label use.
  • A cautious approach is warranted regarding RWE as a transformative solution.