ACI 33rd FDA Boot Camp - Using 'Real World' Evidence to Support Rx Drug Promotion

Linda Pissott Reig, shareholder in the firm's FDA & Biotechnology section, presented "Using 'Real World' Evidence to Support Rx Drug Promotion" at the American Conference Institute's 33rd FDA Boot Camp.

In recent years, both the FDA Reauthorization Act (FDARA) and the 21st Century Cures Act have created new considerations for the approval process related to the incorporation and evaluation of new types of evidence. This session explored the requirements for these new evidentiary proofs, including:

• Examining the key provisions found in FDARA the 21st Century Cures Act
• Defining the key terms used within the guidelines
  • What is Real World Evidence (RWE)?
  • What is the Patient Perspective?
  • Exploring the new types of evidence required for FDA approval
• Ensuring the evidence presented is accurate
  • Are double blind studies necessary to support findings?
• Discussing the uses of RWE within these guidelines
  • What are the proper methods for utilizing and presenting comparative analysis?
• Evaluating how the patient perspective is used in the approval of FDA regulated products
• Understanding the current administration’s perspective on FDARA and the 21st Century Cures Act