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Compliance Alert: Keytruda

Configure Methodology
67
Caution

Keytruda scores 67/100 (Caution) based on analysis of 90s promotional content. 5 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Family & Social Scenes” identified at 45.4s, previously cited in Jardiance (x3), Contrave, Qulipta. Weakest dimension: Visual Distraction at 44/100.

Keytruda | Merck | DTC Broadcast
Mar 7, 2026

Patterns Detected (5)

Matched against 14 enforcement patterns from 42 FDA letters

Visual Distraction
Family & Social Scenes
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
44
45.4s – 52.4s
80.4s – 90.0s
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
44
13.7s – 19.7s
19.7s – 27.3s
FDA Precedent: Contrave, Velsipity, Qulipta, Fasenra (salsa) 21 CFR 202.1(e)(1)
Visual Distraction
Animated/Motion Graphics
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
44
80.4s – 90.0s
80.4s – 90.0s
FDA Precedent: NEXLIZET (Lipid Lurkers) 21 CFR 202.1(e)(1)
Efficacy
Comparative Claims
Advertisements cannot be false or misleading in any particular
65
7.8s – 13.7s
13.7s – 19.7s
19.7s – 27.3s
39.3s – 45.4s
66.2s – 90.0s
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
5
Segments Reclassified
FDA Precedent: BRUKINSA 21 CFR 202.1(e)(3)(iii)
67
Master
44
Visual
30%
65
Efficacy
25%
78
Fair Balance
20%
100
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 3.3s – 89.9s (86.6s of 90.2s total — 96.1% of ad)
13.7s — Daily Activities
19.7s — Daily Activities
45.4s — Family Social
80.4s — Family Social+Vd Animated Motion+Vd Animated Motion
0s90s

Visual Evidence (4 clips)

13.7s – 19.7s Daily Activities
19.7s – 27.3s Daily Activities
45.4s – 52.4s Family Social
80.4s – 90.0s Family Social, Animated Motion, Animated Motion

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (3s–90s) 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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