Lundbeck: Brintellix webinar registration page missing PI/AE statement and amended after certification (AUTH/3450/1/21)

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Key facts

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Case	AUTH/3450/1/21
Company	Lundbeck Limited
Product	Brintellix (vortioxetine)
Activity	Promotional webinar and event registration page (on-demand content)
Webpage title	“Clinical experience of emotional blunting and data on the efficacy of vortioxetine on anhedonia”
Key compliance issues	Missing PI and AE reporting statement on promotional registration page; post-certification amendment (job code change)
Access/public allegation	Alleged public access via lack of firewall and Google search; Panel found no breach on evidence
Breach clauses	4.1, 4.9, 9.1, 14.1
No breach clauses	2, 26.1, 26.2, 28.1, 28.3
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	4 January 2021 (PDF) / 05 January 2021 (HTML listing)
Case completed	5 August 2021
Applicable Code year	2019
Appeal	No appeal

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

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What happened

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An anonymous health professional complained about a Lundbeck Brintellix (vortioxetine) on-demand webinar and its event registration page titled “Clinical experience of emotional blunting and data on the efficacy of vortioxetine on anhedonia”.
The registration page stated “This webinar is organised and funded by Lundbeck”, displayed a large Brintellix logo and the indication (“Vortioxetine is indicated for the treatment of major depressive episodes in adults”).
The complainant alleged the page lacked prescribing information (PI) and adverse event (AE) reporting information, and that it was accessible to the public (no firewall/disclaimer), including via Google search terms “Brintellix UK webinar”.
Lundbeck explained the webinar was a pan-European promotional event (global team in Denmark) aimed at health professionals across nine European countries; UK HCPs were invited by email by representatives to opted-in HCPs.
Lundbeck said PI was provided multiple times via the invitation email/attachments and later during/after the webinar, but acknowledged the registration page itself omitted PI and the AE reporting statement.
Lundbeck also explained that the UK-certified registration page (ref UK-BRIN-0883) was later altered after certification when a global employee instructed the platform provider to change the UK job code to match the webinar slides (ref UK-BRIN-0875), creating an uncertified version available from 14 May 2020 until withdrawal in December 2020 (potentially seen by 57 UK HCP interactions).
The Panel considered evidence that access controls existed (closed platform, search optimisation disabled, registration fields including job title, due diligence validation) and that any Google indexing was unintentional and required very specific search terms after indexing occurred by other means.

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Outcome

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No breach of Clause(s) 2, 26.1, 26.2, 28.1, 28.3 (Panel did not find promotion to the public on the evidence; complainant did not discharge burden of proof).
Breach of Clause(s) 4.1 (registration page was promotional but did not include required prescribing information), 4.9 (no AE reporting statement on the registration page), 14.1 (registration page amended after certification), 9.1 (high standards not maintained).
No ruling made in relation to Clause 4.2 (Panel treated missing PI as a Clause 4.1 issue).
No appeal.

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Key facts

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