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Compliance Alert: Cosentyx

Configure Methodology
59
At Risk

Cosentyx scores 59/100 (At Risk) based on analysis of 60s promotional content. 6 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 21.8s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). Weakest dimension: Fair Balance at 40/100.

Cosentyx | Novartis | DTC Broadcast
Mar 7, 2026

Patterns Detected (6)

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
21.8s – 26.9s
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
21.8s – 26.9s
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
65
21.8s – 26.9s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Efficacy
Dramatic Before/After
Advertisements cannot be false or misleading in any particular
65
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
40
20.69:1
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
40
1
Segments Reclassified
FDA Precedent: BRUKINSA 21 CFR 202.1(e)(3)(iii)
59
Master
55
Visual
30%
65
Efficacy
25%
40
Fair Balance
20%
85
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 23.3s – 26.1s (2.8s of 60.3s total — 4.6% of ad)
21.8s — Daily Activities+Vd Outdoor Physical
0s60s

Visual Evidence (1 clip)

21.8s – 26.9s Daily Activities, Outdoor Physical

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (23s–26s) 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
Flag for next MLR cycle: Benefit-to-risk presentation balance requires attention. Ensure risk information receives comparable prominence, duration, and audio/visual treatment.

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