Austedo XR – Compliance Alert

Caution

This ad has patterns previously flagged by FDA.

Analysis of this 60s ad identified 3 enforcement patterns, primarily Fair Balance. Patterns span Visual Distraction, Fair Balance — “Family & Social Scenes” identified at 31.9s, previously cited in Jardiance (x3), Contrave, Qulipta. FDA enforcement letter on file dated Sep 9, 2025.

Recommended action: Flag for next MLR cycle: Benefit-to-risk presentation balance requires attention. Ensure risk information receives comparable prominence, duration, and audio/visual treatment.

Video Timeline

Risk disclosure: 29.0s – 52.8s (23.8s of 60.1s total — 39.7% of ad)

Risk Window

0s15s30s45s60s

Family & Social?Risk Window?

Patterns Detected (3)

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
Family & Social Scenes Warm family scenes that emotionally minimize risk information	Visual Distraction	66	2 clips	21 CFR 202.1(e)(1)	▶
FDA Concern: Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals Previously cited: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2)
Benefit vs. Risk Time Imbalance Significantly more time spent on benefits than on risks	Fair Balance	58	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: 1.52:1
Audio/Visual Mismatch Risk info presented in audio only without matching visual reinforcement	Fair Balance	58	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

Recommendations

high

Flag for next MLR cycle: Benefit-to-risk presentation balance requires attention. Ensure risk information receives comparable prominence, duration, and audio/visual treatment.

high

Escalate to regulatory affairs: FDA enforcement letter on file (Sep 9, 2025). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

Compliance Alert: Austedo XR

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