AbbVie voluntary admission: out-of-date prescribing information used in Humira banner and journal ads (AUTH/2577/2/13)

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Key facts

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Case number	AUTH/2577/2/13
Company	AbbVie Ltd
Product	Humira (adalimumab)
Issue	Out-of-date prescribing information linked/included in promotional materials
Materials	Online banner ad (rheumatology.org.uk) and print journal ads (four journals)
PI versions	Used: version 23 (last revised May 2011); Current at the time: version 27 (revised December 2012)
Key missing/changed safety info noted by Panel	Missing common side-effects: nerve root compression, pyrexia; missing serious uncommon side-effects: Merkel cell carcinoma, liver failure; precaution monitoring period changed from 5 months to 4 months
Placement timing	Re-used/placed 17 December 2012; print appeared January 2013 editions
UK approval history	Originally approved by UK affiliate October 2011; re-used in 2012 without further UK approval
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

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AbbVie voluntarily admitted that out-of-date prescribing information (PI) was linked to an online Humira (adalimumab) banner ad (ref AXHUR111644a) and included in a print journal ad (ref AXHUR111644).
The materials promoted Humira for moderate to severe, active rheumatoid arthritis and were used again on 17 December 2012.
The ads used PI last revised May 2011 (version 23) rather than the then-current PI revised December 2012 (version 27).
The banner appeared on a UK website (rheumatology.org.uk) and the print ad appeared in four journals (Annals of Rheumatic Disease, Rheumatology, International Rheumatology, Clinical Rheumatology); two were UK-based.
The materials had originally been approved by the UK affiliate in October 2011, but were recommissioned/placed by the global team in December 2012 without further UK approval.
AbbVie requested immediate removal of the banner; it was taken down within an hour of AbbVie becoming aware.
AbbVie tried to stop the print run but was too late to prevent publication in January 2013 issues; the ad was withdrawn from future issues.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 placements on behalf of affiliates.

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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 that fall within the Code’s scope.
The Panel found the PI was not up-to-date regarding side-effects and precautions and therefore did not comply.
Breaches were ruled for Clauses 4.1 and 9.1.

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