Recognizing Potential ATTR-CM Symptoms – Compliance Alert

Lower Risk

This HCP Educational video is within acceptable compliance thresholds.

Analysis of this 197s HCP Educational video identified 3 enforcement patterns, primarily Efficacy. Patterns span Efficacy, Fair Balance — “Comparative Claims” identified at 0.0s, previously cited in NEXLIZET, COBENFY.

Video Timeline

Risk disclosure: 30.6s – 167.3s (136.7s of 197.3s total — 69.3% of ad)

Risk Window

0s49s99s148s197s

No visual distractions detected

Risk Window?

Patterns Detected (3)

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
Comparative Claims Claims suggesting superiority without adequate supporting data	Efficacy	74	1 clip	21 CFR 202.1(e)(5)	▶
FDA Concern: Advertisements cannot be false or misleading in any particular Previously cited: NEXLIZET, COBENFY
Dramatic Before/After Before/after visuals that may overstate treatment outcomes	Efficacy	74		21 CFR 202.1(e)(5)	▶
FDA Concern: Advertisements cannot be false or misleading in any particular Previously cited: TURALIO, TREMFYA
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: 1

Compliance Alert: Recognizing Potential ATTR-CM Symptoms

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