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Compliance Alert: Ingrezza

Configure Methodology
63
Caution

Ingrezza scores 63/100 (Caution) based on analysis of 60s promotional content. 3 enforcement patterns detected across 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. Weakest dimension: Content Lifecycle at 17/100.

Ingrezza | Neurocrine Biosciences | Dtc Broadcast
FDA Letter DOC-2025-001246 Mar 7, 2026

Patterns Detected (3)

Matched against 14 enforcement patterns from 42 FDA letters

Visual Distraction
Daily Activities
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
73
19.8s – 32.3s
FDA Precedent: Contrave, Velsipity, Qulipta, Fasenra (salsa) 21 CFR 202.1(e)(1)
Efficacy
Comparative Claims
Advertisements cannot be false or misleading in any particular
77
13.2s – 25.5s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Fair Balance
Benefit vs. Risk Time Imbalance
Risk and benefit information must be presented with equal prominence
40
25.00:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
63
Master
73
Visual
30%
77
Efficacy
25%
40
Fair Balance
20%
83
Adeq Prov
15%
17
Lifecycle
10%
Safety Information Window
Risk disclosure: 25.7s – 28.0s (2.3s of 60.3s total — 3.8% of ad)
19.8s — Daily Activities
0s60s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (1 clip)

19.8s – 32.3s Daily Activities

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.
medium
Initiate PromoMats review: Content lifecycle dates approaching. Verify talent/music rights expiration and confirm claims substantiation against current data.
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.
Veeva PromoMats Details
Document ID
DOC-2025-001246
Status
Approved for Distribution
Version
1.0
Content Type
Dtc Broadcast
MLR Review
Feb 18, 2025
Next Review Due
Jan 20, 2026 (Expired)
Talent Expiration
Feb 1, 2026 (Expired)
Music License
Aug 1, 2026 (71d)

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