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Why Patient Experience Data Provisions Face Elimination

Jamie Kendall & Alexandra Schulz

Why Patient Experience Data Provisions Face Elimination, Law360, New York (March 22, 2017, 5:05 PM EDT) — Jamie Kendall Alexandra Schulz Leading up to and following the passage of the 21st Century Cures Act[1], much was made of the so-called “patient experience data” provisions and their impact on the U.S. Food and Drug Administration’s regulatory decisions. Patient advocacy groups rallied for the inclusion to champion the patient perspective and bring attention to their diseases and FDA followed suit by supporting the enactment of the Cures Act for the same reasons.[2] Opponents vocally criticized the inclusion of patient experience data as yet another tool…