Grünenthal: Versatis poster deemed promotional and off‑label (AUTH/2330/7/10)

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Key facts

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Case	AUTH/2330/7/10
Parties	Anonymous v Grünenthal
Product	Versatis (lidocaine plaster)
Main issue	Promotion of an unlicensed indication in a poster presentation (and related handout)
Setting	British Pain Society (BPS) independent congress poster session (13–15 April, Manchester)
Key quoted claim	“Versatis has an ‘off-label’ use for the symptomatic relief of localised neuropathic pain, and could provide a substantial saving to the local health-economy”.
Applicable Code year	2008
Complaint received	05 July 2010
Case completed	19 August 2010
Breach clauses	2, 3.2 and 9.1
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Advertisement

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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 complainant submitted a one-page item headed “Localised Neuropathic Pain” referring to Versatis (lidocaine plaster), with a very small footer: “Sponsored by an unrestricted grant by Grünenthal UK Ltd”.
Versatis was indicated for symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).
The highlighted conclusion stated: “Versatis has an ‘off-label’ use for the symptomatic relief of localised neuropathic pain, and could provide a substantial saving to the local health-economy”.
Grünenthal explained the item matched copy from a British Pain Society (BPS) poster and an accompanying handout/reprint.
Grünenthal paid for printing and helped submit the poster to BPS; it said it had no editorial control. A consultant pharmacist appeared to lead development.
A Grünenthal employee provided information and was named as second author, but her Grünenthal position was not declared on the poster; the Panel found it unacceptable that Grünenthal did not make this clear in its response.
The poster discussed prescribing Versatis for “localised neuropathic pain” and quantified annual cost savings versus gabapentin/pregabalin, including a section “Potential Costing Savings (for PHN)”.
The abstract differed from the poster (eg, it identified a Grünenthal role and did not mention “off-label”; it also referenced an educational grant for algorithm development).
Grünenthal said the handout was removed before the congress opened due to poor print quality and “never used”.

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Outcome

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Poster: Ruled to be promotional material; promoted Versatis for an unlicensed indication; breaches found.
Handout: No breach of Clauses 2, 3.2 and 9.1 (because it was not used, per the Panel’s ruling in the circumstances).
No appeal.

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