AUTH/2234/5/09: Novo Nordisk ruled in breach for repeated pre-licence promotion of Victoza (liraglutide) via website, journal insert and meetings

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Key facts

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Case	AUTH/2234/5/09
Parties	Lilly v Novo Nordisk
Product / issue	Promotion of Victoza (liraglutide) prior to the grant of its marketing authorization
Marketing authorisation date (Victoza)	30 June 2009
Complaint received	28 May 2009
Applicable Code year	2008
Completed	08 September 2010
Breach clauses	2 (x4), 3.1 (x4, 7.2 (x4), 7.3 (x4), 7.9, 9.1 (x5) and 12.1 (x3).
Sanctions applied	Undertaking received; Advertisement; Public reprimand; Audit of company’s procedures; Re-audit
Notable “no breach” items	Endocrine and diabetes society meeting (Feb 2009) and diabetes network meeting (Mar 2009) (Novo Nordisk not responsible for content on evidence before Panel)

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

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What happened

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Eli Lilly complained that Novo Nordisk continued to promote Victoza (liraglutide) before UK marketing authorisation, despite a recent prior ruling (AUTH/2202/1/09).
Victoza marketing authorisation was granted on 30 June 2009; the challenged activities occurred mainly in 2008–April 2009.
Educational website (“Realising the promise of the GLP-1 receptor”):
- Registration page displayed: “Thank you for registering with Liraglutide online!” (later removed).
- Module content included detailed liraglutide efficacy/safety information and comparisons with exenatide (Byetta), without being sufficiently clear about regulatory status differences.
- Statement “Liraglutide is not yet licensed in the UK” appeared only at the end of a section and was alleged to be insufficiently prominent.
Sponsored journal supplement / paid insert distributed in the UK with The British Journal of Diabetes & Vascular Disease:
- Presented proceedings of a Novo Nordisk satellite symposium but was framed in a way that implied independence.
- Distributed to UK health professionals when liraglutide did not have a UK marketing authorisation.
- Disclosure on cover (“supported by an educational grant”) was considered misleading given Novo Nordisk’s role and control.
Novo Nordisk Symposium on Diabetes Care (March 2009):
- Keynote lecture titled “A New Molecule in Diabetes – From Conception to Reality” included detailed liraglutide content and comparative slides versus licensed medicines.
- Licensed status was not clearly presented in the materials reviewed by the Panel.
Endocrine and diabetes society meeting (February 2009):
- Concerns raised due to sales department attendance and all speakers being from Novo Nordisk.
- Panel concluded, on limited evidence, it could be legitimate scientific exchange; no breach ruled for this item.
Diabetes network meeting (March 2009):
- Debate title referenced exenatide and liraglutide as “best second line therapy”.
- Panel had concerns about the title and Novo Nordisk’s awareness of it, but found Novo Nordisk not responsible for meeting content; no breach ruled for this item.
Diabetes managed clinical network conference (April 2009):
- Novo Nordisk funded a visiting professor (travel expenses; honorarium alleged) but sponsorship was not declared on agenda/materials.
- Professor’s slides compared Byetta with liraglutide and included unpublished Novo Nordisk data; no clear distinction between licensed and unlicensed products.

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Outcome

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Breaches were ruled for the educational website, the journal paid insert, the Novo Nordisk symposium keynote, and the sponsored professor presentation at the managed clinical network conference.
No breach was ruled for:
- the endocrine and diabetes society meeting (February 2009), and
- the diabetes network meeting (March 2009) where Novo Nordisk was found not responsible for content.
The Panel and Appeal Board expressed extreme concern about repeated pre-authorisation promotion and apparent poor understanding of the Code, including at headquarters level.

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Key facts

What happened

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