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Compliance Alert: Attruby

Configure Methodology
60
At Risk

Attruby scores 60/100 (At Risk) based on analysis of 118s promotional content. 6 enforcement patterns detected across Visual Distraction, Efficacy, Fair Balance — “Outdoor & Physical Activity” identified at 83.6s, previously cited in BRUKINSA, COBENFY, Fasenra (x3). FDA enforcement letter on file dated Sep 9, 2025. Weakest dimension: Visual Distraction at 31/100.

Attruby | Alnylam Pharmaceuticals | Celebrity Endorsement
FDA Letter DOC-2025-001244 Mar 7, 2026

Patterns Detected (6)

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
83.6s – 91.7s
91.7s – 104.9s
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
69.6s – 75.4s
83.6s – 91.7s
FDA Precedent: Jardiance (x3), Contrave, Qulipta, Calquence, Austedo (x2) 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
31
69.6s – 75.4s
75.4s – 83.6s
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
77
104.9s – 111.3s
FDA Precedent: NEXLIZET, COBENFY 21 CFR 202.1(e)(5)
Efficacy
Dramatic Before/After
Advertisements cannot be false or misleading in any particular
77
FDA Precedent: TURALIO, TREMFYA 21 CFR 202.1(e)(5)
Fair Balance
Benefit vs. Risk Time Imbalance
Risk and benefit information must be presented with equal prominence
73
1.95:1
Benefit:Risk Ratio
FDA Precedent: FABHALTA, Vyvgart Hytrulo (x2), Wegovy, Vonjo 21 CFR 202.1(e)(3)(iii)
60
Master
31
Visual
30%
77
Efficacy
25%
73
Fair Balance
20%
85
Adeq Prov
15%
38
Lifecycle
10%
Safety Information Window
Risk disclosure: 64.9s – 104.7s (39.8s of 117.7s total — 33.9% of ad)
69.6s — Daily Activities+Vd Family Social
75.4s — Daily Activities
83.6s — Outdoor Physical+Vd Family Social
91.7s — Outdoor Physical
0s118s
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →

Visual Evidence (4 clips)

69.6s – 75.4s Daily Activities, Family Social
75.4s – 83.6s Daily Activities
83.6s – 91.7s Outdoor Physical, Family Social
91.7s – 104.9s Outdoor Physical

Recommendations

high
Flag for next MLR cycle: Visual content during safety information window (65s–105s) may distract from risk disclosure. Schedule creative revision to use static or neutral visuals during major statement.
medium
Initiate PromoMats review: Content lifecycle dates approaching. Verify talent/music rights expiration and confirm claims substantiation against current data.
high
Escalate to regulatory affairs: FDA enforcement letter on file (Sep 9, 2025). Verify remediation status in PromoMats and confirm all content modifications address cited violations before next distribution.
Veeva PromoMats Details
Document ID
DOC-2025-001244
Status
Approved for Distribution
Version
1.0
Content Type
Celebrity Endorsement
MLR Review
Jun 18, 2025
Next Review Due
May 20, 2026 (Expired)
Talent Expiration
Dec 1, 2025 (Expired)
Music License
Jun 1, 2026 (10d)

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