AUTH/3057/8/18: CCG employee v Novo Nordisk (Victoza) — no breach over alleged handwritten eGFR claim | PMCPA Case

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Key facts

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Case number	AUTH/3057/8/18
Complainant	Clinical commissioning group (CCG) employee (head of prescribing and medicines management)
Company	Novo Nordisk
Product(s)	Victoza (liraglutide); Tresiba (insulin degludec) mentioned in scanned materials
Issue	Alleged instruction to receptionist to handwrite a promotional claim about Victoza use at eGFR <15 (note actually read “can be used in eGFR 15”)
Applicable Code year	2016
Clauses considered	2, 3.2, 9.1, 15.2
Panel decision	No breach
Complaint received	15 August 2018
Case completed	16 October 2018
Appeal	No appeal
Published	May 2019 Code of Practice Review

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

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The head of prescribing and medicines management at a CCG complained about promotion of Victoza (liraglutide) by a named Novo Nordisk representative.
Allegation: on 8 August 2018 the representative asked a receptionist to handwrite a note on Victoza promotional material to tell GPs the product could be used in eGFR <15, and said the rep could not write it themself.
The complainant supplied a scanned copy showing stacked materials (Victoza and Tresiba leavepieces, the rep’s business card) and a handwritten note reading “can be used in eGFR 15”, plus additional handwritten annotations suggesting it was “Added by receptionist on direction of rep”.
Novo Nordisk denied the allegation; the representative denied asking the receptionist to write any note and described the visit as a speculative call to identify a diabetes specialist nurse and attempt to book an appointment.
The Panel reviewed the Victoza SPC wording on renal impairment and considered whether the handwritten note was inconsistent with the licence.
During its response, Novo Nordisk discovered a typographical error on a July 2018 training slide stating Victoza could be used “down to less than 15” eGFR; Novo Nordisk said presenters clarified verbally that use was down to eGFR 15 and the representative did not attend that training. Novo Nordisk issued a clarifying briefing document in August 2018.

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No breach of the Code was ruled.
The Panel found the handwritten note stated “can be used in eGFR 15” (not “<15” as alleged).
The Panel considered the note a product claim and stated it was not acceptable for a representative to handwrite claims on materials for health professionals or to instruct a receptionist to do so.
However, the Panel did not consider the complainant had proved, on the balance of probabilities, that the representative asked the receptionist to write the note (the parties’ accounts differed).
The Panel considered the note did not appear inconsistent with the Victoza SPC and therefore ruled no breach on the narrow allegation.

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