AbbVie breached certification rules for an uncoded ‘Pathways’ workshop document at a Synagis promotional meeting (AUTH/2997/12/17)

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Key facts

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Case	AUTH/2997/12/17
Complainant	Anonymous contactable health professional
Company	AbbVie
Medicine	Synagis (palivizumab)
Issue	Alleged inappropriate use of CHD case studies and influence to prescribe outside NHSE guidelines; uncoded/uncertified workshop scenarios document
Meeting	“Mini Embrace 2017, Empower, Educate & Engage” (15 September 2017)
Applicable Code year	2016
Complaint received	18 December 2017
Case completed	17 July 2018
Appeal	No appeal
Breach clauses	Clause 9.1; Clause 14.1
No breach clauses	Clause 2; Clause 7.2; Clause 7.4; Clause 15.2
Sanctions	Undertaking received

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

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An anonymous, contactable health professional complained about how an AbbVie representative presented Synagis (palivizumab) clinical data at a hospital meeting (15 Sept 2017) titled “Mini Embrace 2017, Empower, Educate & Engage”.
The complainant alleged the representative presented specific CHD patient case studies and reasons they should receive Synagis prophylaxis, that slides appeared added outside the medical approval process (no preparation codes), and that a request for copies was refused.
The complainant believed AbbVie was trying to influence prescribing for all CHD patients outside NHS England (NHSE) guidelines and that claims lacked published references or local audit support.
AbbVie said the CHD presentation was promotional and certified, and included only a single illustrative case study with a disclaimer.
AbbVie said a separate “Pathways” document (three hypothetical scenarios with discussion questions) was printed and left on tables for workshop discussion, not formally presented.
AbbVie acknowledged the Pathways document had not been certified because organisers considered it non-promotional, and said relevant team members were being re-trained.

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No breach of Clause 2.
No breach of Clause 7.2 (alleged misleading influence to prescribe outside NHSE guidelines not established).
No breach of Clause 7.4 (insufficiently particularised allegation about lack of references/audits).
No breach of Clause 15.2 (no evidence representative failed to maintain high standards on the narrow allegation).
Breach of Clause 14.1 because the Pathways document was promotional and not certified.
Breach of Clause 9.1 because failure to recognise the promotional nature of the Pathways document and certify it meant AbbVie failed to maintain high standards.

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