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Compliance Alert: Kesimpta

Configure Methodology
64
Caution

Kesimpta scores 64/100 (Caution) based on analysis of 60s promotional content. 6 enforcement patterns detected across 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. Weakest dimension: Visual Distraction at 31/100.

Kesimpta | Novartis | Celebrity Endorsement
FDA Letter DOC-2025-001247 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
31
20.9s – 28.5s
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
31
20.9s – 28.5s
28.5s – 34.8s
41.1s – 48.0s
53.5s – 60.0s
FDA Precedent: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2) 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
31
41.1s – 48.0s
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
68
14.1s – 20.8s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Efficacy
Dramatic Before/After
Advertisements cannot be false or misleading in any particular
68
FDA Precedent: TURALIO, TREMFYA 21 CFR 202.1(e)(5)
Fair Balance
Audio/Visual Mismatch
Audio/visual mismatch — benefit segments contained risk content requiring reclassification
100
1
Segments Reclassified
FDA Precedent: BRUKINSA 21 CFR 202.1(e)(3)(iii)
64
Master
31
Visual
30%
68
Efficacy
25%
100
Fair Balance
20%
90
Adeq Prov
15%
38
Lifecycle
10%
Safety Information Window
Risk disclosure: 20.8s – 59.9s (39.0s of 60.2s total — 64.8% of ad)
20.9s — Outdoor Physical+Vd Family Social
28.5s — Family Social
41.1s — Daily Activities+Vd Family Social
53.5s — Family Social
0s60s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (4 clips)

20.9s – 28.5s Outdoor Physical, Family Social
28.5s – 34.8s Family Social
41.1s – 48.0s Daily Activities, Family Social
53.5s – 60.0s Family Social

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.
medium
Initiate PromoMats review: Content lifecycle dates approaching. Verify talent/music rights expiration and confirm claims substantiation against current data.
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.
Veeva PromoMats Details
Document ID
DOC-2025-001247
Status
Approved for Distribution
Version
1.0
Content Type
Celebrity Endorsement
MLR Review
May 28, 2025
Next Review Due
May 1, 2026 (Expired)
Talent Expiration
Nov 15, 2025 (Expired)
Music License
May 1, 2026 (Expired)

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