Ingrezza – 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, Efficacy, Fair Balance — “Daily Activities” identified at 19.8s, previously cited in Contrave, Velsipity, Qulipta. FDA enforcement letter on file dated Sep 9, 2025. Benefit-to-risk presentation ratio is 25.0:1.

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: 25.7s – 28.0s (2.3s of 60.3s total — 3.8% of ad)

Risk Window

0s15s30s45s60s

Daily Activities?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
Daily Activities Relatable lifestyle visuals that divert attention from safety disclosures	Visual Distraction	73	1 clip	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: Contrave, Velsipity, Qulipta, Fasenra (salsa)
Comparative Claims Claims suggesting superiority without adequate supporting data	Efficacy	77	1 clip	21 CFR 202.1(e)(5)	▶
FDA Concern: Advertisements cannot be false or misleading in any particular Previously cited: NEXLIZET, COBENFY
Benefit vs. Risk Time Imbalance Significantly more time spent on benefits than on risks	Fair Balance	40	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: 25.00:1

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: Ingrezza

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