AbbVie voluntary admission: out-of-date Humira prescribing information used in UK online banner and journal ads (AUTH/2577/2/13)

📊

Key facts

⌄

Case number	AUTH/2577/2/13
Company	AbbVie Ltd
Product	Humira (adalimumab)
Issue	Out-of-date prescribing information linked/included in promotional advertisements
Materials	Online banner ad (ref AXHUR111644a) and hard copy journal ad (ref AXHUR111644)
Where it appeared	rheumatology.org.uk (UK website) and journals including UK-based Annals of Rheumatic Disease and Rheumatology
Timing	Ads used/placed 17 December 2012; print appeared January 2013 editions
PI versions	Used: version 23 (last revised May 2011); Current at time: version 27 (revised December 2012)
What was missing/changed vs current PI	Did not include common side-effects nerve root compression and pyrexia; did not include serious uncommon side-effects Merkel cell carcinoma and liver failure; infection monitoring period stated as 5 months (updated to 4 months)
Complaint received	06 February 2013
Case completed	14 March 2013
Applicable Code year	2012
Breach clauses	Clause 4.1 and Clause 9.1
Sanctions	Undertaking received; additional sanctions: Not stated
Appeal	No appeal

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

AbbVie voluntarily admitted that out-of-date prescribing information (PI) was linked to an online Humira (adalimumab) banner ad (ref AXHUR111644a) and included in a hard copy journal ad (ref AXHUR111644).
The ads promoted Humira for moderate to severe, active rheumatoid arthritis and were used again on 17 December 2012.
The banner appeared on a UK website (rheumatology.org.uk); print ads appeared in four journals: Annals of Rheumatic Disease, Rheumatology (both UK-based), International Rheumatology and Clinical Rheumatology.
The PI used was version 23 (last revised May 2011). The current PI at the time was version 27 (revised December 2012).
AbbVie stated the global rheumatology team commissioned the placements in December 2012 without further UK approval, reusing materials previously approved by the UK affiliate in October 2011.
AbbVie removed the online banner within an hour of identifying the issue; it was too late to stop the print ads appearing in January 2013 issues, but they were withdrawn from future issues.
AbbVie attributed the issue to an individual error (a new employee not following the update/withdrawal process) and said retraining was underway; an updated global SOP was being developed to prevent global marketing placing local-market ads.

⚖️

⌄

The Panel ruled the materials were within the scope of the Code (UK website and UK-based journals).
The Panel reiterated that UK companies are responsible for acts/omissions of overseas parents/affiliates when within the scope of the Code.
The Panel found the PI was not up-to-date regarding side-effects and precautions and therefore did not comply with the Code.
Breaches were ruled for failure to provide compliant prescribing information and for failure to maintain high standards.
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access