AUTH/3817/9/23: AstraZeneca SENTINEL Plus website and MART references — no breach

📅 2023 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3817/9/23
CompanyAstraZeneca UK Limited
ComplainantAnonymous, contactable
Material / activitySENTINEL Plus website (HCP resource) including references to Maintenance and Reliever Therapy (MART)
Main allegationIndirect promotion of Symbicort via MART references; missing prescribing information and prominent AE reporting statement
Applicable Code year2021
Clauses considered2, 5.1, 12.1, 12.9
Panel decisionNo breach of Clauses 2, 5.1, 12.1, 12.9
Rationale (in brief)On balance and based on limited material, webpages were not promotional; MART is a treatment plan with multiple licensed inhalers and no specific medicine was referenced; therefore PI and AE statement not required
Complaint received29 August 2023
Case completed8 November 2024
AppealNo appeal
SanctionsNone stated

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

  • An anonymous complainant alleged AstraZeneca’s SENTINEL Plus website (for HCPs) contained multiple references to Maintenance and Reliever Therapy (MART) in the context of increasing MART prescribing.
  • The complainant argued this was an indirect reference to AstraZeneca’s Symbicort (licensed for MART) and therefore constituted promotion.
  • They alleged the relevant pages lacked prescribing information (PI) and the prominent adverse event (AE) reporting statement.
  • AstraZeneca responded that the website was a non-promotional, balanced quality-improvement resource supporting evidence-based asthma guideline implementation; MART was discussed as an established approach with multiple licensed inhalers (six at the time), not a specific brand.
  • The Panel considered the limited webpages provided, noted the broad definition of promotion (Clause 1.17), and assessed whether the material pointed to a specific medicine.
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Outcome

  • No breach of Clause 2.
  • No breach of Clause 5.1.
  • No breach of Clause 12.1.
  • No breach of Clause 12.9.
  • The Panel concluded (on balance, given limited material) the webpages at issue were not promotional; therefore PI and the AE reporting statement were not required.
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