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Compliance Alert: BRUKINSA

Configure Methodology
58
At Risk

BRUKINSA scores 58/100 (At Risk) based on analysis of 60s promotional content. 4 enforcement patterns detected across Visual Distraction, Efficacy — “Outdoor & Physical Activity” identified at 21.5s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Jan 7, 2026. Weakest dimension: Visual Distraction at 31/100.

BRUKINSA | BeiGene (BeOne Medicines) | DTC Broadcast
FDA Letter Mar 7, 2026

Patterns Detected (4)

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
31
21.5s – 26.6s
38.6s – 44.9s
44.9s – 50.7s
FDA Precedent: BRUKINSA, COBENFY, Fasenra (x3), Velsipity, Calquence 21 CFR 202.1(e)(1)
Visual Distraction
Family & Social Scenes
Risk information must be presented in a clear, conspicuous, and neutral manner without distracting visuals
31
21.5s – 26.6s
26.6s – 32.3s
44.9s – 50.7s
50.7s – 60.0s
FDA Precedent: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2) 21 CFR 202.1(e)(1)
Efficacy
Comparative Claims
Advertisements cannot be false or misleading in any particular
48
0.0s – 5.0s
10.2s – 16.1s
16.2s – 21.4s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Efficacy
Dramatic Before/After
Advertisements cannot be false or misleading in any particular
48
FDA Precedent: TURALIO, TREMFYA 21 CFR 202.1(e)(5)
58
Master
31
Visual
30%
48
Efficacy
25%
78
Fair Balance
20%
100
Adeq Prov
15%
--
Lifecycle
10%
Safety Information Window
Risk disclosure: 23.4s – 59.2s (35.8s of 60.0s total — 59.7% of ad)
21.5s — Family Social+Vd Outdoor Physical
26.6s — Family Social
38.6s — Outdoor Physical
44.9s — Family Social+Vd Outdoor Physical
50.7s — Family Social
0s60s
!
FDA Enforcement Action on File
FDA Letter Jan 7, 2026 View PDF →

Visual Evidence (5 clips)

21.5s – 26.6s Family Social, Outdoor Physical
26.6s – 32.3s Family Social
38.6s – 44.9s Outdoor Physical
44.9s – 50.7s Family Social, Outdoor Physical
50.7s – 60.0s Family Social

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (23s–59s) 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 (Jan 7, 2026). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.

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