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Compliance Alert: Farxiga

Configure Methodology
66
Caution

Farxiga scores 66/100 (Caution) based on analysis of 45s promotional content. 4 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 0.0s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 23, 2025. Weakest dimension: Visual Distraction at 44/100.

Farxiga | AstraZeneca Pharmaceuticals LP | DTC Broadcast
FDA Letter 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
0.0s – 18.4s
24.5s – 32.1s
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
44
0.0s – 18.4s
FDA Precedent: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2) 21 CFR 202.1(e)(1)
Efficacy
Comparative Claims
Advertisements cannot be false or misleading in any particular
74
9.2s – 18.4s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Fair Balance
Audio/Visual Mismatch
Audio/visual mismatch — benefit segments contained risk content requiring reclassification
78
1
Segments Reclassified
FDA Precedent: BRUKINSA 21 CFR 202.1(e)(3)(iii)
66
Master
44
Visual
30%
74
Efficacy
25%
78
Fair Balance
20%
83
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 0.7s – 41.9s (41.2s of 45.2s total — 91.0% of ad)
0.0s — Outdoor Physical+Vd Family Social
24.5s — Outdoor Physical
0s45s
!
FDA Enforcement Action on File
FDA Letter Sep 23, 2025 View PDF →

Visual Evidence (2 clips)

0.0s – 18.4s Outdoor Physical, Family Social
24.5s – 32.1s Outdoor Physical

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (1s–42s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.
high
Escalate to regulatory affairs: FDA enforcement letter on file (Sep 23, 2025). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

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