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Compliance Alert: TREMFYA

Configure Methodology
70
Caution

TREMFYA scores 70/100 (Caution) based on analysis of 45s promotional content. 4 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 18.7s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Feb 6, 2026. Weakest dimension: Visual Distraction at 55/100.

TREMFYA | Janssen Biotech (Johnson & Johnson) | DTC Broadcast
FDA Letter Mar 7, 2026

Patterns Detected (4)

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
55
18.7s – 25.9s
33.5s – 38.9s
FDA Precedent: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence 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
55
33.5s – 38.9s
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
74
9.7s – 25.9s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Fair Balance
Audio/Visual Mismatch
Audio/visual mismatch — benefit segments contained risk content requiring reclassification
68
1
Segments Reclassified
FDA Precedent: BRUKINSA 21 CFR 202.1(e)(3)(iii)
70
Master
55
Visual
30%
74
Efficacy
25%
68
Fair Balance
20%
93
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 25.5s – 44.0s (18.5s of 45.0s total — 41.0% of ad)
18.7s — Outdoor Physical
33.5s — Outdoor Physical+Vd Daily Activities
0s45s
!
FDA Enforcement Action on File
FDA Letter Feb 6, 2026 View PDF →

Visual Evidence (2 clips)

18.7s – 25.9s Outdoor Physical
33.5s – 38.9s Outdoor Physical, Daily Activities

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (26s–44s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.
high
Escalate to regulatory affairs: FDA enforcement letter on file (Feb 6, 2026). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

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