← Dashboard

Compliance Alert: Velsipity

Configure Methodology
58
At Risk

Velsipity scores 58/100 (At Risk) based on analysis of 60s promotional content. 4 enforcement patterns detected across Visual Distraction, Fair Balance — “Outdoor & Physical Activity” identified at 26.8s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 9, 2025. Weakest dimension: Content Lifecycle at 17/100.

Velsipity | Pfizer | Dtc Broadcast
FDA Letter DOC-2025-001236 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
44
26.8s – 36.2s
36.2s – 50.3s
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
44
26.8s – 36.2s
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
26.8s – 36.2s
26.8s – 36.2s
36.2s – 50.3s
FDA Precedent: Contrave, Velsipity, Qulipta, Fasenra (salsa) 21 CFR 202.1(e)(1)
Fair Balance
Benefit vs. Risk Time Imbalance
Risk and benefit information must be presented with equal prominence
63
2.03:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
58
Master
44
Visual
30%
75
Efficacy
25%
63
Fair Balance
20%
75
Adeq Prov
15%
17
Lifecycle
10%
Safety Information Window
Risk disclosure: 30.3s – 50.2s (19.9s of 60.2s total — 33.0% of ad)
26.8s — Daily Activities+Vd Outdoor Physical+Vd Family Social+Vd Daily Activities
36.2s — Daily Activities+Vd Outdoor Physical
0s60s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (2 clips)

26.8s – 36.2s Daily Activities, Outdoor Physical, Family Social, Daily Activities
36.2s – 50.3s Daily Activities, Outdoor Physical

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (30s–50s) 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-2025-001236
Status
Approved for Distribution
Version
1.0
Content Type
Dtc Broadcast
MLR Review
Aug 28, 2024
Next Review Due
Aug 1, 2025 (Expired)
Talent Expiration
Aug 15, 2025 (Expired)
Music License
Dec 31, 2025 (Expired)

Powered by cQuenced