AUTH/1967/2/07: PCT prescribing lead v Novartis — alleged claim that Exforge was PCT-endorsed (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/1967/2/07
Complainant	Primary care trust head of prescribing and pharmacy services
Company	Novartis Pharmaceuticals UK Ltd
Product(s)	Exforge (amlodipine/valsartan); Diovan (valsartan); Co-Diovan (valsartan/hydrochlorothiazide)
Issue	Alleged claim that Exforge was endorsed by the PCT
Applicable Code year	2006
Clauses considered	7.2 and 15.2
Panel decision	No breach
Complaint received	23 February 2007
Case completed	20 April 2007
Appeal	No appeal
Notes	Panel found insufficient evidence on the balance of probabilities; misunderstanding likely between Exforge and Diovan when discussing endorsement/formulary status.

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

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The head of prescribing and pharmacy services at a primary care trust (PCT) complained that a Novartis representative stated at a surgery that Exforge (amlodipine/valsartan) was endorsed by the PCT.
The complaint was based on a report from a PCT pharmacist about a conversation between a dispensary manager and the representative (i.e., submitted by a third party).
Novartis investigated by interviewing the pharmaceutical advisor, the dispensary manager and the representative, and reviewed the representative’s call records (visit dated 15 February).
Novartis said the representative discussed Exforge as part of its hypertension portfolio (alongside Co-Diovan and Diovan), including BHS guidelines, patient profile, efficacy, cost and dosing, and said he would be interested to hear the PCT’s view of Exforge.
The representative also discussed ARB use and said Diovan had been included as a formulary choice following a local hospital trust ARB review; he had been told local PCTs might adopt similar guidance.
The dispensary manager initially recalled the rep saying Exforge was endorsed by the PCT, but during review of the discussion accepted a misunderstanding had occurred (she assumed the rep was still talking about Exforge when he had moved to Diovan).
Novartis instructed representatives to make transitions between products “absolutely clear” given the close relationship between Exforge and Diovan.

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No breach of the Code was found.
The Panel considered there was insufficient evidence, on the balance of probabilities, that the representative stated Exforge was endorsed by the PCT as alleged.
The Panel noted the parties’ accounts differed and it was not possible to determine where the truth lay.

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