Novo Nordisk v Lilly: Diabetes UK satellite symposium and Byetta exhibition claims (AUTH/2310/4/10)

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Key facts

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Case	AUTH/2310/4/10
Parties	Novo Nordisk v Lilly
Product / topic	Byetta (exenatide); exenatide long-acting release (LAR) / once-weekly formulation
Setting	Diabetes UK Annual Professional Conference (Liverpool, 3–5 March 2010) and Lilly symposium on eve of conference
Complaint received	07 April 2010
Case completed	02 November 2010
Applicable Code year	2008
Key issues	Whether symposium was promotional; pre-licence promotion of exenatide LAR/once-weekly; misleading regulatory status; misleading exhibition claims based on completer population
Breach clauses (as published)	2, 3.1 (x2), 7.2 (x2) and 9.1 (x2)
Sanctions (as published)	Undertaking received; Additional sanctions: Advertisement
Appeal	Appeal by respondent; key rulings upheld by the Appeal Board

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

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Novo Nordisk complained about Lilly’s activities around the Diabetes UK Annual Professional Conference (Liverpool, 3–5 March 2010), including a Lilly-sponsored symposium held on the eve of the conference and Lilly exhibition panels.
The symposium was invitation-only, controlled by Lilly, and included travel and overnight accommodation for some attendees (36 reimbursed travel; 25 provided accommodation). The event included drinks/canapés, a scientific session, pre-dinner drinks and dinner.
The invitation included prescribing information for Byetta and stated the emphasis would be on how information might enhance attendees’ current and future clinical practice.
Presentation 1 (external speaker): ABCD Nationwide Exenatide Audit Update. Complaint alleged off-licence Byetta + insulin use was presented without clear disclosure.
Presentation 2 (external speaker): Comparison of incretin-based therapies. Included multiple slides on exenatide long-acting release (LAR) / once-weekly dosing (not licensed at the time) without slide statements about licence status.
Presentation 3 (Lilly employee): Overview of future GLP-1 receptor agonists. Included positive overview and data on exenatide once-weekly (not licensed at the time), with two slides stating it was not currently licensed.
Exhibition panels (promotional stand): Included graphs and claims derived from Klonoff et al (2008), including “Almost half (46%) of patients achieved HbA1c ≤7%” based on a 3-year completer population.

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Presentation 1: No breach of Clauses 3.2 and 7.2 (Panel did not find, on balance of probabilities, that reserve slides about exenatide + insulin were used; presentation not misleading about licensed use and did not promote Byetta with insulin).
Presentation 2: Breach of Clause 3.1 and Clause 7.2 (pre-licence promotion of exenatide LAR and misleading regulatory status). Upheld on appeal.
Presentation 3: Breach of Clause 3.1 (pre-licence promotion of exenatide once-weekly). No breach of Clause 7.2 for misleading regulatory status. Breach of Clause 9.1 and Clause 2 (high standards not maintained; Clause 2 as particular censure). Upheld on appeal.
Exhibition panels: No breach for the shortened y-axis/suppressed zero allegation (Clauses 7.2, 7.8, 9.1 not breached on that point). However, breach of Clause 7.2 and Clause 9.1 for omission of important context leading to misleading impressions (eg “46%” claim applied only to completers). No breach of Clause 2 for the exhibition panel.
Overall case (as listed on PMCPA page): Breach Clause(s) 2, 3.1 (x2), 7.2 (x2) and 9.1 (x2).

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