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Compliance Alert: Qulipta

Configure Methodology
60
At Risk

Qulipta scores 60/100 (At Risk) based on analysis of 30s promotional content. 2 enforcement patterns detected across Visual Distraction — “Outdoor & Physical Activity” identified at 0.0s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 9, 2025. Weakest dimension: Content Lifecycle at 17/100.

Qulipta | AbbVie | Dtc Broadcast
FDA Letter DOC-2025-001242 Mar 7, 2026

Patterns Detected (2)

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
50
0.0s – 24.1s
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
50
0.0s – 24.1s
FDA Precedent: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2) 21 CFR 202.1(e)(1)
60
Master
50
Visual
30%
75
Efficacy
25%
68
Fair Balance
20%
75
Adeq Prov
15%
17
Lifecycle
10%
Safety Information Window
Risk disclosure: 13.2s – 25.4s (12.2s of 30.3s total — 40.3% of ad)
0.0s — Family Social+Vd Outdoor Physical
0s30s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (1 clip)

0.0s – 24.1s Family Social, Outdoor Physical

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (13s–25s) 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-2025-001242
Status
Approved for Distribution
Version
2.0
Content Type
Dtc Broadcast
MLR Review
Apr 22, 2025
Next Review Due
Mar 25, 2026 (Expired)
Talent Expiration
Apr 10, 2026 (Expired)
Music License
Oct 1, 2026

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