TREMFYA – Compliance Alert

Caution

This ad has patterns previously flagged by FDA.

Analysis of this 45s ad identified 4 enforcement patterns, primarily Visual Distraction. Patterns span Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 18.7s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Feb 6, 2026.

Recommended action: 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.

Video Timeline

Risk disclosure: 25.5s – 44.0s (18.5s of 45.0s total — 41.0% of ad)

Risk Window

0s11s22s34s45s

Outdoor & Physical?Risk Window?

Patterns Detected (4)

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	55	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: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence
Daily Activities Relatable lifestyle visuals that divert attention from safety disclosures	Visual Distraction	55	1 clip	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
Audio/Visual Mismatch Risk info presented in audio only without matching visual reinforcement	Fair Balance	68	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

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

Escalate to regulatory affairs: FDA enforcement letter on file (Feb 6, 2026). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

Compliance Alert: TREMFYA

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