Support for Patients Throughout the Attruby Treatment Journey – Compliance Alert

Lower Risk

This Patient Support video is within acceptable compliance thresholds.

Analysis of this 303s Patient Support video identified 2 enforcement patterns, primarily Fair Balance. Patterns span Fair Balance, previously cited in FABHALTA, Vyvgart Hytrulo (x2), Wegovy. Benefit-to-risk presentation ratio is 8.2:1.

Video Timeline

Risk disclosure: 207.5s – 240.5s (33.0s of 302.9s total — 10.9% of ad)

Risk Window

0s76s151s227s303s

No visual distractions detected

Risk Window?

Patterns Detected (2)

Each pattern below is a known FDA enforcement concern, identified by matching this ad against 14 violation types from 34 FDA warning letters

Pattern	Dimension	Score	Evidence	CFR
Benefit vs. Risk Time Imbalance Significantly more time spent on benefits than on risks	Fair Balance	68	1 metric	21 CFR 202.1(e)(3)(iii)	▶
FDA Concern: Risk and benefit information must be presented with equal prominence Previously cited: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo Benefit:Risk Ratio: 8.17:1
Audio/Visual Mismatch Risk info presented in audio only without matching visual reinforcement	Fair Balance	68	1 metric	21 CFR 202.1(e)(3)(iii)	▶
FDA Concern: Audio/visual mismatch — benefit segments contained risk content requiring reclassification Previously cited: BRUKINSA Segments Reclassified: 1

Compliance Alert: Support for Patients Throughout the Attruby Treatment Journey

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