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Compliance Alert: Attruby

Configure Methodology
62
Caution
This ad has patterns previously flagged by FDA.

Analysis of this 118s ad identified 6 enforcement patterns, primarily Visual Distraction. Patterns span 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.

Recommended action: 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.

Attruby | Alnylam Pharmaceuticals | Celebrity Endorsement
FDA Letter DOC-2025-001244 Mar 7, 2026
62
Master
31
Visual
30%
77
Efficacy
25%
73
Fair Balance
20%
85
Adeq Prov
15%
--
Lifecycle
10%
Video Timeline
Risk disclosure: 64.9s – 104.7s (39.8s of 117.7s total — 33.9% of ad)
Risk Window
0s29s59s88s118s
Daily Activities?Relatable daily-life visuals during risk narration divert attention from important safety disclosures.Outdoor & Physical?Upbeat outdoor imagery shown during risk narration can distract viewers from hearing safety warnings. The FDA has cited this pattern in multiple enforcement letters.Risk Window?The portion of the ad where side effects and safety warnings are narrated. Distracting visuals during this window are an FDA enforcement priority.
Patterns Detected (6)
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 31 2 clips 21 CFR 202.1(e)(1)
Family & Social Scenes
Warm family scenes that emotionally minimize risk information
Visual Distraction 31 2 clips 21 CFR 202.1(e)(1)
Daily Activities
Relatable lifestyle visuals that divert attention from safety disclosures
Visual Distraction 31 2 clips 21 CFR 202.1(e)(1)
Comparative Claims
Claims suggesting superiority without adequate supporting data
Efficacy 77 1 clip 21 CFR 202.1(e)(5)
Dramatic Before/After
Before/after visuals that may overstate treatment outcomes
Efficacy 77 21 CFR 202.1(e)(5)
Benefit vs. Risk Time Imbalance
Significantly more time spent on benefits than on risks
Fair Balance 73 1 metric 21 CFR 202.1(e)(3)(iii)

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.
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.
!
FDA Enforcement Action on File
FDA Letter Sep 9, 2025 View PDF →
Full Video Preview 1:58 · DTC Broadcast
Morgan Freeman Talks About Attruby (acoramidis).mp4
Duration: 1:58 Alert: ALT-2026-0014
Veeva PromoMats Details
Synthetic data for demonstration purposes. In production, this section is populated from Veeva PromoMats via API integration.
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 (65d)
Talent Expiration
Dec 1, 2025 (Expired)
Music License
Jun 1, 2026 (77d)