Kesimpta – Compliance Alert

Caution

This ad has patterns previously flagged by FDA.

Analysis of this 60s ad identified 6 enforcement patterns, primarily Visual Distraction. Patterns span Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 20.9s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 9, 2025.

Recommended action: Flag for next MLR cycle: Visual content during safety information window (21s–60s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.

Video Timeline

Risk disclosure: 20.8s – 59.9s (39.0s of 60.2s total — 64.8% of ad)

Risk Window

0s15s30s45s60s

Outdoor & Physical?Family & Social?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	31	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
Family & Social Scenes Warm family scenes that emotionally minimize risk information	Visual Distraction	31	4 clips	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: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2)
Daily Activities Relatable lifestyle visuals that divert attention from safety disclosures	Visual Distraction	31	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	68	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	68		21 CFR 202.1(e)(5)	▶
FDA Concern: Advertisements cannot be false or misleading in any particular Previously cited: TURALIO, TREMFYA
Audio/Visual Mismatch Risk info presented in audio only without matching visual reinforcement	Fair Balance	100	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 (21s–60s) 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 9, 2025). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

Compliance Alert: Kesimpta

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