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PMCPA Case

AstraZeneca: promotional meeting misclassified and LinkedIn engagement led to pre-authorisation promotion and public advertising findings (AUTH/3729/1/23)

📅 2023 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/3729/1/23
CompanyAstraZeneca UK Limited
Complaint themeAlleged promotional activities (meeting content and social media engagement; plus allegations about MSL pressure and EAP seeding)
Number of complaintsSix (amalgamated)
Complaint received14 December 2022
Case completed22 July 2024
AppealNo appeal
Applicable Code year2021 (Complaint 2 ruled under representative clauses in 2019 Code)
Medicines mentionedTagrisso (osimertinib); Iressa (gefitinib); capivasertib; Imfinzi (durvalumab); olaparib (Lynparza) (OlympiA EAP context); acalabrutinib (Complaint 2)
Key breach driversPromotional meeting treated as non-promotional; lack of certification/PI; misleading implication from “cure”; LinkedIn likes/reposts treated as dissemination/promotion; pre-authorisation promotion; promotion to the public
SanctionsUndertaking received; Additional sanctions: Advertisement

Download the full case report (PDF)

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

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What happened

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  • Complaint 1 (Jan 2022 webinar): A UK virtual “Early Stage Think Tank”/“Surgical Think Tank” meeting was presented as non-promotional, but the Panel considered it promotional given the content and context (AstraZeneca-organised; slides referencing Tagrisso and gefitinib trials and product-related messaging).
  • The meeting materials were not certified as promotional material and did not include prescribing information (PI) for Tagrisso/gefitinib, despite being promotional (Panel view).
  • The presentation included discussion of gefitinib trials in completely resected patients (IMPACT/ADJUVANT), which the Panel considered not in accordance with gefitinib’s marketing authorisation (handled under Clause 5.1).
  • Slides used the term “cure” in a traffic-light style depiction of outcomes; the Panel found some uses created a potentially misleading implication (especially where OS benefit was uncertain and the audience was multidisciplinary).
  • Complaint 2 (LinkedIn posts, early 2021): Two posts allegedly promoting Tagrisso and acalabrutinib were made by an individual before they joined AstraZeneca; Panel held AstraZeneca not responsible in the circumstances.
  • Complaint 3 (LinkedIn likes/repost): UK-based AstraZeneca employees (including very senior staff) liked and reposted a third-party research institute post describing capivasertib’s “remarkable benefits” and linking to more trial information; this brought the content into scope and was treated as dissemination/promotion.
  • Complaint 4 (LinkedIn like): A UK-based employee liked a post sharing an academic article with an overall survival graph for Tagrisso; the like was treated as proactive dissemination to connections, including the public.
  • Complaint 5 (MSLs/Imfinzi): Allegations that MSLs were pressured to promote Imfinzi off-label in quarterly account review meetings; Panel found the complainant did not discharge the burden of proof.
  • Complaint 6 (EAPs/OlympiA EAP): Allegations that Early Access Programmes were seeding/disguised promotion; Panel found insufficient evidence and accepted the programme was offered reactively on unsolicited request.
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Outcome

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  • Complaint 1: Breach of Clause 5.1 (x3); Breach of Clause 6.1 (x2); Breach of Clause 8.1. No breach of Clause 2, Clause 3.1, Clause 5.2, Clause 15.6 (and no ruling on some points where no discrete allegation was found).
  • Complaint 2 (2019 Code): No breach of Clause 2, Clause 9.1, Clause 12.1, Clause 14.1, Clause 26.1.
  • Complaint 3: Breach of Clause 2; Breach of Clause 3.1; Breach of Clause 5.1. No breach of Clause 26.1.
  • Complaint 4: Breach of Clause 5.1; Breach of Clause 26.1. No breach of Clause 2.
  • Complaint 5: No breach of Clause 5.1; No breach of Clause 17.2; No breach of Clause 17.9.
  • Complaint 6: No breach of Clause 5.1; No breach of Clause 11.1; No breach of Clause 17.9.
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