Cosentyx – Compliance Alert

At Risk

This ad has a high risk of FDA enforcement action.

Analysis of this 60s ad identified 6 enforcement patterns, primarily Fair Balance. Patterns span Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 21.8s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). Benefit-to-risk presentation ratio is 20.7:1.

Recommended action: 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.

Video Timeline

Risk disclosure: 23.3s – 26.1s (2.8s of 60.3s total — 4.6% of ad)

Risk Window

0s15s30s45s60s

Daily Activities?Risk Window?

Patterns Detected (6)

Each pattern below is a known FDA enforcement concern, identified by matching this ad against 14 violation types from 34 FDA warning letters

Pattern	Dimension	Score	Evidence	CFR
Outdoor & Physical Activity Upbeat outdoor imagery shown while safety warnings are being read	Visual Distraction	55	1 clip	21 CFR 202.1(e)(1)	▶
FDA Concern: Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals Previously cited: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence
Daily Activities Relatable lifestyle visuals that divert attention from safety disclosures	Visual Distraction	55	1 clip	21 CFR 202.1(e)(1)	▶
FDA Concern: Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals Previously cited: Contrave, Velsipity, Qulipta, Fasenra (salsa)
Comparative Claims Claims suggesting superiority without adequate supporting data	Efficacy	65	1 clip	21 CFR 202.1(e)(5)	▶
FDA Concern: Advertisements cannot be false or misleading in any particular Previously cited: NEXLIZET, COBENFY
Dramatic Before/After Before/after visuals that may overstate treatment outcomes	Efficacy	65		21 CFR 202.1(e)(5)	▶
FDA Concern: Advertisements cannot be false or misleading in any particular Previously cited: TURALIO, TREMFYA
Benefit vs. Risk Time Imbalance Significantly more time spent on benefits than on risks	Fair Balance	40	1 metric	21 CFR 202.1(e)(3)(iii)	▶
FDA Concern: Risk and benefit information must be presented with equal prominence Previously cited: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo Benefit:Risk Ratio: 20.69:1
Audio/Visual Mismatch Risk info presented in audio only without matching visual reinforcement	Fair Balance	40	1 metric	21 CFR 202.1(e)(3)(iii)	▶
FDA Concern: Audio/visual mismatch — benefit segments contained risk content requiring reclassification Previously cited: BRUKINSA Segments Reclassified: 1

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.

Compliance Alert: Cosentyx

Recommendations