FABHALTA – Compliance Alert

At Risk

This ad has a high risk of FDA enforcement action.

Analysis of this 90s ad identified 5 enforcement patterns, primarily Efficacy. Patterns span Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 56.1s, 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 (47s–80s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.

Video Timeline

Risk disclosure: 46.6s – 80.2s (33.6s of 90.0s total — 37.3% of ad)

Risk Window

0s23s45s68s90s

Outdoor & Physical?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
Outdoor & Physical Activity Upbeat outdoor imagery shown while safety warnings are being read	Visual Distraction	50	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	50	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	48	2 clips	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	48		21 CFR 202.1(e)(5)	▶
FDA Concern: Advertisements cannot be false or misleading in any particular Previously cited: TURALIO, TREMFYA
Benefit vs. Risk Time Imbalance Significantly more time spent on benefits than on risks	Fair Balance	73	1 metric	21 CFR 202.1(e)(3)(iii)	▶
FDA Concern: Risk and benefit information must be presented with equal prominence Previously cited: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo Benefit:Risk Ratio: 1.68:1

Recommendations

high

Flag for next MLR cycle: Visual content during safety information window (47s–80s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.

high

Initiate PromoMats review: Verify all efficacy claims against current approved labeling. Visual representations should align with clinical trial results referenced in the PI.

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: FABHALTA

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