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Compliance Alert: Contrave

Configure Methodology
63
Caution

Contrave scores 63/100 (Caution) based on analysis of 90s promotional content. 4 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Family & Social Scenes” identified at 42.3s, previously cited in Jardiance (x3), Contrave, Qulipta. FDA enforcement letter on file dated Sep 9, 2025. Weakest dimension: Content Lifecycle at 17/100.

Contrave | Currax Pharmaceuticals | Dtc Broadcast
FDA Letter DOC-2025-001237 Mar 7, 2026

Patterns Detected (4)

Matched against 14 enforcement patterns from 42 FDA letters

Visual Distraction
Family & Social Scenes
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
68
42.3s – 51.9s
FDA Precedent: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2) 21 CFR 202.1(e)(1)
Visual Distraction
Daily Activities
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
68
51.9s – 60.5s
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
84.8s – 90.0s
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
5.65:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
63
Master
68
Visual
30%
77
Efficacy
25%
40
Fair Balance
20%
93
Adeq Prov
15%
17
Lifecycle
10%
Safety Information Window
Risk disclosure: 42.4s – 55.9s (13.6s of 90.1s total — 15.0% of ad)
42.3s — Family Social
51.9s — Daily Activities
0s90s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (2 clips)

42.3s – 51.9s Family Social
51.9s – 60.5s 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-2025-001237
Status
Approved for Distribution
Version
1.0
Content Type
Dtc Broadcast
MLR Review
Jan 28, 2025
Next Review Due
Jan 1, 2026 (Expired)
Talent Expiration
Jan 10, 2026 (Expired)
Music License
Jun 1, 2026 (10d)

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