COBENFY – Compliance Alert

Caution

This ad has patterns previously flagged by FDA.

Analysis of this 60s ad identified 3 enforcement patterns, primarily Visual Distraction. Patterns span Visual Distraction, Efficacy — “Outdoor & Physical Activity” identified at 19.6s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Dec 15, 2025.

Recommended action: Flag for next MLR cycle: Visual content during safety information window (24s–51s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.

Video Timeline

Risk disclosure: 23.8s – 50.5s (26.7s of 59.9s total — 44.5% of ad)

Risk Window

0s15s30s45s60s

Daily Activities?Outdoor & Physical?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
Outdoor & Physical Activity Upbeat outdoor imagery shown while safety warnings are being read	Visual Distraction	49	5 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: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence
Daily Activities Relatable lifestyle visuals that divert attention from safety disclosures	Visual Distraction	49	3 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)
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

Recommendations

high

Flag for next MLR cycle: Visual content during safety information window (24s–51s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.

high

Escalate to regulatory affairs: FDA enforcement letter on file (Dec 15, 2025). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

Compliance Alert: COBENFY

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