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Compliance Alert: FABHALTA

Configure Methodology
60
At Risk

FABHALTA scores 60/100 (At Risk) based on analysis of 90s promotional content. 5 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 56.1s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 23, 2025. Weakest dimension: Efficacy at 48/100.

FABHALTA | Novartis Pharmaceuticals | DTC Broadcast
FDA Letter Mar 7, 2026

Patterns Detected (5)

Matched against 14 enforcement patterns from 42 FDA letters

Visual Distraction
Outdoor & Physical Activity
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
50
56.1s – 62.3s
72.5s – 80.7s
FDA Precedent: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence 21 CFR 202.1(e)(1)
Visual Distraction
Family & Social Scenes
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
50
72.5s – 80.7s
FDA Precedent: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2) 21 CFR 202.1(e)(1)
Efficacy
Comparative Claims
Advertisements cannot be false or misleading in any particular
48
34.3s – 50.3s
62.4s – 72.5s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Efficacy
Dramatic Before/After
Advertisements cannot be false or misleading in any particular
48
FDA Precedent: TURALIO, TREMFYA 21 CFR 202.1(e)(5)
Fair Balance
Benefit vs. Risk Time Imbalance
Risk and benefit information must be presented with equal prominence
73
1.68:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
60
Master
50
Visual
30%
48
Efficacy
25%
73
Fair Balance
20%
85
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 46.6s – 80.2s (33.6s of 90.0s total — 37.3% of ad)
56.1s — Outdoor Physical
72.5s — Outdoor Physical+Vd Family Social
0s90s
!
FDA Enforcement Action on File
FDA Letter Sep 23, 2025 View PDF →

Visual Evidence (2 clips)

56.1s – 62.3s Outdoor Physical
72.5s – 80.7s Outdoor Physical, Family Social

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (47s–80s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.
high
Initiate PromoMats review: Verify all efficacy claims against current approved labeling. Visual representations should align with clinical trial results referenced in the PI.
high
Escalate to regulatory affairs: FDA enforcement letter on file (Sep 23, 2025). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

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