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Compliance Alert: Neffy

Configure Methodology
62
Caution

Neffy scores 62/100 (Caution) based on analysis of 60s promotional content. 2 enforcement patterns detected across 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. Weakest dimension: Fair Balance at 48/100.

Neffy | ARS Pharmaceuticals | DTC Broadcast
FDA Letter Mar 7, 2026

Patterns Detected (2)

Matched against 14 enforcement patterns from 42 FDA letters

Visual Distraction
Outdoor & Physical Activity
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
55
11.0s – 16.8s
FDA Precedent: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence 21 CFR 202.1(e)(1)
Fair Balance
Benefit vs. Risk Time Imbalance
Risk and benefit information must be presented with equal prominence
48
8.46:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
62
Master
55
Visual
30%
75
Efficacy
25%
48
Fair Balance
20%
75
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 9.4s – 15.8s (6.3s of 60.0s total — 10.6% of ad)
11.0s — Outdoor Physical
0s60s
!
FDA Enforcement Action on File
FDA Letter Jan 23, 2026 View PDF →

Visual Evidence (1 clip)

11.0s – 16.8s Outdoor Physical

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.

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