AUTH/2311/4/10: Anonymous v AstraZeneca — Seroquel meeting alleged off-label promotion (No breach) | PMCPA Case

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Key facts

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Case	AUTH/2311/4/10
Parties	Anonymous v AstraZeneca
Product	Seroquel (quetiapine)
Allegation	Misleading meeting content and promotion of Seroquel outwith its marketing authorisation (BPD)
Meeting date (company account)	5 November 2009
Complaint received	15 April 2010
Case completed	8 July 2010
Applicable Code year	2008
Appeal	No appeal
Clauses considered	Clauses 2, 3.2, 7.2, 9.1, 12.1 and 15.2
Outcome	No breach
Notable Panel comment	Failure to retain invitation/agenda/slides and lack of certification described as “wholly unacceptable” / “extremely poor practice”

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

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An anonymous complainant alleged an AstraZeneca-sponsored meeting was misleading and promoted Seroquel (quetiapine) outside its marketing authorisation (for borderline personality disorder (BPD)).
Seroquel was licensed for schizophrenia and bipolar disorder.
The complainant said the meeting was billed as “Cognitive treatment of borderline personality disorder (BPD)”, then moved to medicines and recommended Seroquel as “medicine of choice”, without stating it was unlicensed for BPD.
AstraZeneca said the only relevant meeting at the venue (5 Nov 2009) was a schizophrenia case study (“Management of Schizophrenia”) aligned to the Seroquel SPC; BPD was only discussed in response to an unsolicited audience question.
The speaker allegedly used a separate slide deck on BPD (saved on his laptop) to answer the question; AstraZeneca said the representative was unaware of this deck.
AstraZeneca could not provide copies of the invitation, agenda, or slides used at the meeting; the Panel described this as “wholly unacceptable” and “extremely poor practice”.
Witness recollections differed: one attendee recalled schizophrenia; two recalled BPD-focused content, but neither supported that quetiapine was recommended for BPD.

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No breach of the Code was ruled.
The Panel found no evidence, on the balance of probabilities, that Seroquel was promoted for BPD (no breach of Clause 3.2).
The Panel found no evidence delegates were misled about Seroquel (no breach of Clause 7.2).
The Panel found no evidence of disguised promotion (no breach of Clause 12.1).
The Panel found no evidence the representative failed to maintain a high standard of ethical conduct (no breach of Clause 15.2).
Despite strong criticism of missing records and lack of certified slides, the Panel ruled no breach of Clause 9.1 and therefore no breach of Clause 2.

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