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Compliance Alert: Jardiance

Configure Methodology
64
Caution

Jardiance scores 64/100 (Caution) based on analysis of 75s promotional content. 4 enforcement patterns detected across Visual Distraction — “Outdoor & Physical Activity” identified at 16.8s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 9, 2025. Weakest dimension: Visual Distraction at 38/100.

Jardiance | Boehringer Ingelheim Pharmaceuticals | Dtc Broadcast
FDA Letter DOC-2025-001245 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
38
16.8s – 24.6s
24.6s – 31.1s
37.7s – 43.1s
54.0s – 59.3s
54.0s – 59.3s
54.0s – 59.3s
54.0s – 59.3s
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
38
54.0s – 59.3s
54.0s – 59.3s
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
38
16.8s – 24.6s
54.0s – 59.3s
FDA Precedent: Contrave, Velsipity, Qulipta, Fasenra (salsa) 21 CFR 202.1(e)(1)
Visual Distraction
Animated/Motion Graphics
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
38
37.7s – 43.1s
37.7s – 43.1s
54.0s – 59.3s
FDA Precedent: NEXLIZET (Lipid Lurkers) 21 CFR 202.1(e)(1)
64
Master
38
Visual
30%
75
Efficacy
25%
93
Fair Balance
20%
75
Adeq Prov
15%
41
Lifecycle
10%
Safety Information Window
Risk disclosure: 19.7s – 68.5s (48.9s of 75.2s total — 65.0% of ad)
16.8s — Outdoor Physical+Vd Daily Activities
24.6s — Outdoor Physical
37.7s — Outdoor Physical+Vd Animated Motion+Vd Animated Motion
54.0s — Outdoor Physical+Vd Outdoor Physical+Vd Family Social+Vd Family Social+Vd Outdoor Physical+Vd Outdoor Physical+Vd Daily Activities+Vd Animated Motion
0s75s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (4 clips)

16.8s – 24.6s Outdoor Physical, Daily Activities
24.6s – 31.1s Outdoor Physical
37.7s – 43.1s Outdoor Physical, Animated Motion, Animated Motion
54.0s – 59.3s Outdoor Physical, Outdoor Physical, Family Social, Family Social, Outdoor Physical, Outdoor Physical, Daily Activities, Animated Motion

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (20s–69s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.
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-2025-001245
Status
Approved for Distribution
Version
3.0
Content Type
Dtc Broadcast
MLR Review
Jul 18, 2025
Next Review Due
Jun 20, 2026 (29d)
Talent Expiration
Jul 1, 2026 (40d)
Music License
Jan 1, 2027

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