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Compliance Alert: Sotyktu

Configure Methodology
54
At Risk

Sotyktu scores 54/100 (At Risk) based on analysis of 60s promotional content. 6 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 30.7s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). Weakest dimension: Visual Distraction at 44/100.

Sotyktu | BMS | 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
44
30.7s – 36.4s
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
36.4s – 43.1s
43.1s – 49.1s
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
48
18.8s – 30.7s
49.1s – 60.0s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Efficacy
Dramatic Before/After
Advertisements cannot be false or misleading in any particular
48
FDA Precedent: TURALIO, TREMFYA 21 CFR 202.1(e)(5)
Fair Balance
Benefit vs. Risk Time Imbalance
Risk and benefit information must be presented with equal prominence
48
2.22:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
Fair Balance
Audio/Visual Mismatch
Audio/visual mismatch — benefit segments contained risk content requiring reclassification
48
1
Segments Reclassified
FDA Precedent: BRUKINSA 21 CFR 202.1(e)(3)(iii)
54
Master
44
Visual
30%
48
Efficacy
25%
48
Fair Balance
20%
93
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 25.6s – 44.3s (18.7s of 60.1s total — 31.1% of ad)
30.7s — Outdoor Physical
36.4s — Family Social
43.1s — Family Social
0s60s

Visual Evidence (3 clips)

30.7s – 36.4s Outdoor Physical
36.4s – 43.1s Family Social
43.1s – 49.1s Family Social

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (26s–44s) 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.

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