Farxiga – 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 0.0s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 23, 2025.

Recommended action: Flag for next MLR cycle: Visual content during safety information window (1s–42s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.

Video Timeline

Risk disclosure: 0.7s – 41.9s (41.2s of 45.2s total — 91.0% of ad)

Risk Window

0s11s23s34s45s

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	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: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence
Family & Social Scenes Warm family scenes that emotionally minimize risk information	Visual Distraction	44	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: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2)
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	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

Recommendations

high

Flag for next MLR cycle: Visual content during safety information window (1s–42s) 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 (Sep 23, 2025). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

Compliance Alert: Farxiga

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