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Compliance Alert: COBENFY

Configure Methodology
68
Caution

COBENFY scores 68/100 (Caution) based on analysis of 60s promotional content. 3 enforcement patterns detected across Visual Distraction, Efficacy — “Outdoor & Physical Activity” identified at 19.6s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Dec 15, 2025. Weakest dimension: Visual Distraction at 49/100.

COBENFY | Karuna Therapeutics (Bristol Myers Squibb) | DTC Broadcast
FDA Letter Mar 7, 2026

Patterns Detected (3)

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
49
19.6s – 27.6s
33.5s – 39.4s
33.5s – 39.4s
33.5s – 39.4s
45.7s – 59.0s
FDA Precedent: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence 21 CFR 202.1(e)(1)
Visual Distraction
Daily Activities
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
49
19.6s – 27.6s
33.5s – 39.4s
45.7s – 59.0s
FDA Precedent: Contrave, Velsipity, Qulipta, Fasenra (salsa) 21 CFR 202.1(e)(1)
Efficacy
Comparative Claims
Advertisements cannot be false or misleading in any particular
74
12.6s – 19.6s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
68
Master
49
Visual
30%
74
Efficacy
25%
68
Fair Balance
20%
93
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 23.8s – 50.5s (26.7s of 59.9s total — 44.5% of ad)
19.6s — Daily Activities+Vd Outdoor Physical
33.5s — Outdoor Physical+Vd Daily Activities+Vd Outdoor Physical+Vd Outdoor Physical
45.7s — Daily Activities+Vd Outdoor Physical
0s60s
!
FDA Enforcement Action on File
FDA Letter Dec 15, 2025 View PDF →

Visual Evidence (3 clips)

19.6s – 27.6s Daily Activities, Outdoor Physical
33.5s – 39.4s Outdoor Physical, Daily Activities, Outdoor Physical, Outdoor Physical
45.7s – 59.0s Daily Activities, Outdoor Physical

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (24s–51s) 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 (Dec 15, 2025). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

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