Keytruda – Compliance Alert

Caution

This ad has compliance risks that should be reviewed.

Analysis of this 90s ad identified 5 enforcement patterns, primarily Visual Distraction. Patterns span Visual Distraction, Efficacy, Fair Balance — “Family & Social Scenes” identified at 45.4s, previously cited in Jardiance (x3), Contrave, Qulipta.

Recommended action: 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.

Video Timeline

Risk disclosure: 3.3s – 89.9s (86.6s of 90.2s total — 96.1% of ad)

Risk Window

0s23s45s68s90s

Daily Activities?Family & Social?Risk Window?

Patterns Detected (5)

Each pattern below is a known FDA enforcement concern, identified by matching this ad against 14 violation types from 34 FDA warning letters

Pattern	Dimension	Score	Evidence	CFR
Family & Social Scenes Warm family scenes that emotionally minimize risk information	Visual Distraction	44	2 clips	21 CFR 202.1(e)(1)	▶
FDA Concern: Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals Previously cited: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2)
Daily Activities Relatable lifestyle visuals that divert attention from safety disclosures	Visual Distraction	44	2 clips	21 CFR 202.1(e)(1)	▶
FDA Concern: Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals Previously cited: Contrave, Velsipity, Qulipta, Fasenra (salsa)
Animated/Motion Graphics Motion graphics that visually compete with risk narration	Visual Distraction	44	2 clips	21 CFR 202.1(e)(1)	▶
FDA Concern: Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals Previously cited: NEXLIZET (Lipid Lurkers)
Comparative Claims Claims suggesting superiority without adequate supporting data	Efficacy	65	5 clips	21 CFR 202.1(e)(5)	▶
FDA Concern: Advertisements cannot be false or misleading in any particular Previously cited: NEXLIZET, COBENFY
Audio/Visual Mismatch Risk info presented in audio only without matching visual reinforcement	Fair Balance	78	1 metric	21 CFR 202.1(e)(3)(iii)	▶
FDA Concern: Audio/visual mismatch — benefit segments contained risk content requiring reclassification Previously cited: BRUKINSA Segments Reclassified: 5

Compliance Alert: Keytruda

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