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Compliance Alert: Dupixent

Configure Methodology
63
Caution

Dupixent scores 63/100 (Caution) based on analysis of 60s promotional content. 6 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 9.1s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). Weakest dimension: Visual Distraction at 25/100.

Dupixent | Sanofi/Regeneron | DTC Broadcast
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
25
9.1s – 15.4s
22.3s – 38.2s
38.3s – 43.9s
44.0s – 49.9s
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
25
22.3s – 38.2s
22.3s – 38.2s
38.3s – 43.9s
44.0s – 49.9s
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
25
15.5s – 22.3s
38.3s – 43.9s
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
60
0.0s – 9.1s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Efficacy
Dramatic Before/After
Advertisements cannot be false or misleading in any particular
60
FDA Precedent: TURALIO, TREMFYA 21 CFR 202.1(e)(5)
Fair Balance
Audio/Visual Mismatch
Audio/visual mismatch — benefit segments contained risk content requiring reclassification
100
3
Segments Reclassified
FDA Precedent: BRUKINSA 21 CFR 202.1(e)(3)(iii)
63
Master
25
Visual
30%
60
Efficacy
25%
100
Fair Balance
20%
93
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 15.4s – 48.8s (33.3s of 60.3s total — 55.3% of ad)
9.1s — Outdoor Physical
15.5s — Daily Activities
22.3s — Outdoor Physical+Vd Family Social+Vd Family Social
38.3s — Outdoor Physical+Vd Family Social+Vd Daily Activities
44.0s — Outdoor Physical+Vd Family Social
0s60s

Visual Evidence (5 clips)

9.1s – 15.4s Outdoor Physical
15.5s – 22.3s Daily Activities
22.3s – 38.2s Outdoor Physical, Family Social, Family Social
38.3s – 43.9s Outdoor Physical, Family Social, Daily Activities
44.0s – 49.9s Outdoor Physical, Family Social

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (15s–49s) 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.

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