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Compliance Alert: Linzess

Configure Methodology
65
Caution

Linzess scores 65/100 (Caution) based on analysis of 60s promotional content. 5 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Family & Social Scenes” identified at 35.9s, previously cited in Jardiance (x3), Contrave, Qulipta. FDA enforcement letter on file dated Sep 9, 2025. Weakest dimension: Content Lifecycle at 17/100.

Linzess | AbbVie/Ironwood | Dtc Broadcast
FDA Letter DOC-2025-001241 Mar 7, 2026

Patterns Detected (5)

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
35.9s – 41.9s
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
48.6s – 54.4s
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
17.5s – 30.5s
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
48
2.80:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
Fair Balance
Audio/Visual Mismatch
Audio/visual mismatch — benefit segments contained risk content requiring reclassification
48
1
Segments Reclassified
FDA Precedent: BRUKINSA 21 CFR 202.1(e)(3)(iii)
65
Master
68
Visual
30%
77
Efficacy
25%
48
Fair Balance
20%
93
Adeq Prov
15%
17
Lifecycle
10%
Safety Information Window
Risk disclosure: 35.4s – 51.2s (15.9s of 60.3s total — 26.3% of ad)
35.9s — Family Social
48.6s — Daily Activities
0s60s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (2 clips)

35.9s – 41.9s Family Social
48.6s – 54.4s 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-2025-001241
Status
Approved for Distribution
Version
2.0
Content Type
Dtc Broadcast
MLR Review
Jun 1, 2025
Next Review Due
May 5, 2026 (Expired)
Talent Expiration
May 20, 2026 (Expired)
Music License
Nov 1, 2026

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