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Compliance Alert: Jublia

Configure Methodology
54
At Risk

Jublia scores 54/100 (At Risk) based on analysis of 60s promotional content. 6 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 35.8s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 9, 2025. Weakest dimension: Content Lifecycle at 38/100.

Jublia | Bausch Health | Dtc Broadcast
FDA Letter DOC-2025-001235 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
44
35.8s – 49.5s
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
44
17.8s – 25.2s
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
44
30.5s – 35.8s
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
48
17.8s – 25.2s
25.3s – 30.5s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Efficacy
Dramatic Before/After
Advertisements cannot be false or misleading in any particular
48
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
48
2.33:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
54
Master
44
Visual
30%
48
Efficacy
25%
48
Fair Balance
20%
100
Adeq Prov
15%
38
Lifecycle
10%
Safety Information Window
Risk disclosure: 22.1s – 40.1s (18.1s of 60.1s total — 30.0% of ad)
17.8s — Family Social
30.5s — Daily Activities
35.8s — Outdoor Physical
0s60s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (3 clips)

17.8s – 25.2s Family Social
30.5s – 35.8s Daily Activities
35.8s – 49.5s Outdoor Physical

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (22s–40s) 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.
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-2025-001235
Status
Approved for Distribution
Version
1.0
Content Type
Dtc Broadcast
MLR Review
Mar 18, 2025
Next Review Due
Feb 20, 2026 (Expired)
Talent Expiration
Mar 1, 2026 (Expired)
Music License
Jun 1, 2026 (10d)

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