Novartis voluntary admission: Exforge advert published in UK journals before UK marketing authorisation (AUTH/1945/1/07)

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Key facts

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Case number	AUTH/1945/1/07
Company	Novartis Pharmaceuticals UK Ltd
Product	Amlodipine/valsartan (Exforge)
Issue	Promotion/advertisement feature published before UK marketing authorisation
Where published	Hospital Doctor (9 January 2007) and Doctor (11 January 2007)
UK MA date (stated)	17 January 2007
Complaint received	16 January 2007
Proceedings commenced	18 January 2007
Case completed	28 February 2007
Applicable Code year	2006
Breach clauses	Clause 3.1 and Clause 9.1
Clause 2	Considered; not breached
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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Novartis voluntarily advised the PMCPA that an advertisement/advertisement feature for amlodipine/valsartan (Exforge), described as “currently in development”, appeared in Hospital Doctor (9 January 2007) and Doctor (11 January 2007).
At the time of publication, Exforge had a positive CHMP opinion but did not yet have a UK marketing authorisation (UK MA granted 17 January 2007).
Novartis stated the UK affiliate did not place the advertisement and was unaware of it until after publication (triggered by a call to medical information asking about licence status).
The advertisement originated from an agency working on behalf of Novartis’ parent company in Basle/Basel; Novartis described “basic errors” by individuals who should have known the Code and UK publishing requirements.
Novartis informed the MHRA on 17 January 2007, apologised, investigated urgently, reprimanded those involved, and sought assurances/steps to prevent recurrence.

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Breach of Clause 3.1 ruled (promotion prior to grant of UK marketing authorisation).
Breach of Clause 9.1 ruled (high standards not maintained).
No breach of Clause 2 (Panel did not consider the circumstances warranted particular censure under Clause 2).
Undertaking received.
No appeal.

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