Lundbeck: ‘Educational hub’ article found to be disguised promotion and off-label for Abilify Maintena (AUTH/3452/1/21)

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Key facts

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Case	AUTH/3452/1/21
Company	Lundbeck Limited
Product	Abilify Maintena (aripiprazole) prolonged-release suspension for injection (co-promoted)
Channel	Lundbeck UK Progress in Mind Psychiatry and Neurology resource centre website (HCP gated)
Main issues	Disguised promotion on an “educational hub”; off-label promotion (adjunctive MDD); missing obligatory information; inaccurate/unsubstantiated efficacy/safety claims; governance/certification failures
Applicable Code year	2019
Complaint received	14 January 2021
Case completed	10 November 2021
Breach clauses	2, 3.2, 4.1, 4.6, 4.9, 7.2, 7.4, 7.9, 9.1, 12.1
Appeal	Yes (Lundbeck appealed Clause 12.1); appeal unsuccessful
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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An anonymous health professional complained about a webpage on Lundbeck UK’s gated “Progress in Mind” Psychiatry and Neurology resource centre.
A Lundbeck MSL had directed the complainant to the site as a non-promotional educational hub for UK health professionals.
An article titled ‘Towards new treatment options for MDD and schizophrenia: a role for D2 receptor partial agonists’ discussed dopamine D2 receptor partial agonists and atypical antipsychotics, implying benefits including “fewer undesirable side effects” and use in adjunctive treatment of major depressive disorder (MDD).
The complainant alleged the article was disguised promotion for Abilify/Abilify Maintena (aripiprazole) and included off-label recommendations (depression) and misleading tolerability messaging.
Lundbeck accepted the article was promotional (indirect promotion of Abilify Maintena, which it co-promoted) and accepted it was not intended for UK use; it said the article appeared due to cloned global content and failures in the UK approval/certification process.
The article omitted mandatory information (prescribing information, where it could be found, and adverse event reporting statement).
Lundbeck said the website had been taken down before it received the complaint and analytics suggested only one registrant accessed the article.
Lundbeck appealed only the Clause 12.1 ruling (disguised promotion). The appeal was unsuccessful.

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Breach rulings: Clauses 2, 3.2, 4.1, 4.6, 4.9, 7.2, 7.4, 7.9, 9.1 and 12.1.
The Panel found the article promoted Abilify Maintena, included off-label promotion (adjunctive MDD), contained incorrect/inappropriate efficacy and safety information, and omitted obligatory information.
The Panel ruled the promotional nature was disguised because the site was presented as an educational resource and the statement about Lundbeck’s support appeared at the bottom rather than being clear from the outset.
The Appeal Board upheld the Clause 12.1 breach, emphasizing context: HCPs would not necessarily expect promotional content on a certified non-promotional educational hub.

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