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Compliance Alert: Fasenra

Configure Methodology
57
At Risk

Fasenra scores 57/100 (At Risk) based on analysis of 60s promotional content. 5 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 10.0s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 9, 2025. Weakest dimension: Content Lifecycle at 38/100.

Fasenra | AstraZeneca | Dtc Broadcast
FDA Letter DOC-2025-001243 Mar 7, 2026

Patterns Detected (5)

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
10.0s – 35.0s
42.0s – 50.6s
42.0s – 50.6s
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
42.0s – 50.6s
50.6s – 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
38
42.0s – 50.6s
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
62
0.0s – 9.9s
18.2s – 28.0s
35.0s – 42.0s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Fair Balance
Benefit vs. Risk Time Imbalance
Risk and benefit information must be presented with equal prominence
58
1.92:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
57
Master
38
Visual
30%
62
Efficacy
25%
58
Fair Balance
20%
100
Adeq Prov
15%
38
Lifecycle
10%
Safety Information Window
Risk disclosure: 30.5s – 51.1s (20.6s of 60.1s total — 34.2% of ad)
10.0s — Outdoor Physical
42.0s — Outdoor Physical+Vd Daily Activities+Vd Outdoor Physical+Vd Family Social
50.6s — Family Social
0s60s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (3 clips)

10.0s – 35.0s Outdoor Physical
42.0s – 50.6s Outdoor Physical, Daily Activities, Outdoor Physical, Family Social
50.6s – 60.0s Family Social

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (31s–51s) 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-2025-001243
Status
Approved for Distribution
Version
1.0
Content Type
Dtc Broadcast
MLR Review
Mar 28, 2025
Next Review Due
Mar 1, 2026 (Expired)
Talent Expiration
Mar 15, 2026 (Expired)
Music License
Sep 1, 2026

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