Neffy – Compliance Alert

Caution

This ad has patterns previously flagged by FDA.

Analysis of this 60s ad identified 2 enforcement patterns, primarily Fair Balance. Patterns span Visual Distraction, Fair Balance — “Outdoor & Physical Activity” identified at 11.0s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Jan 23, 2026. Benefit-to-risk presentation ratio is 8.5:1.

Recommended action: Flag for next MLR cycle: Visual content during safety information window (9s–16s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.

Video Timeline

Risk disclosure: 9.4s – 15.8s (6.3s of 60.0s total — 10.6% of ad)

Risk Window

0s15s30s45s60s

Outdoor & Physical?Risk Window?

Patterns Detected (2)

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	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: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence
Benefit vs. Risk Time Imbalance Significantly more time spent on benefits than on risks	Fair Balance	48	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: 8.46:1

Recommendations

high

Flag for next MLR cycle: Visual content during safety information window (9s–16s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.

high

Flag for next MLR cycle: Benefit-to-risk presentation balance requires attention. Ensure risk information receives comparable prominence, duration, and audio/visual treatment.

high

Escalate to regulatory affairs: FDA enforcement letter on file (Jan 23, 2026). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

Compliance Alert: Neffy

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