Anonymous GP v Lilly (AUTH/2301/3/10): alleged pre-licence promotion of exenatide once-weekly (Byetta) – no breach | PMCPA Case

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Key facts

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Case number	AUTH/2301/3/10
Parties	Anonymous general practitioner v Eli Lilly and Company Limited
Product	Byetta (exenatide); exenatide once-weekly (long-acting formulation) referenced
Allegation	Alleged promotion/misleading statements about UK launch timing of an unlicensed long-acting exenatide
Complaint received	02 March 2010
Case completed	25 March 2010
Applicable Code	2008
Clauses considered	3.1 and 7.2
Panel decision	No breach (complaint not proven on balance of probabilities)
Appeal	No appeal
Notable Panel comment	Queried whether HDM advance-notification activity met Clause 3.1 supplementary information (cost/budgetary implications and significance)

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

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An anonymous, uncontactable GP alleged that two different Lilly representatives said a long-acting version of exenatide (Byetta) would be launched in the UK “within the next couple of months”.
The GP said their own research suggested there had been no European product licence application and felt the statements were deliberately misleading.
The PMCPA asked Lilly to comment in relation to Clauses 3.1 and 7.2 (Code 2008).
Lilly stated exenatide once-weekly was not licensed; an EMEA application was submitted in March 2010 and a European licence was anticipated in 2011.
Lilly said its sales force was instructed to promote only licensed products (including Byetta) and had not been given materials about exenatide once-weekly.
Lilly described a specific conference briefing (Diabetes UK Conference, Liverpool, 3–5 March 2010): all staff attending were briefed on 2 March 2010 to state reactively that exenatide once-weekly was not licensed and to refer enquiries to clinical research physicians or medical information; other staff were instructed not to engage in conversation about it.
Lilly also said health development managers (HDMs) were trained mid-February to provide advance notification because of potential NHS budget impact, in line with Clause 3.1 supplementary information.
The Panel noted it could not determine whether the individuals were sales representatives or HDMs, and the complainant provided no identifying details, dates or venues.

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No breach ruled: the complaint was not proven on the balance of probabilities.
No breach of Clauses 3.1 and 7.2 was ruled.
The Panel nevertheless queried whether HDM activities met the supplementary information to Clause 3.1 on advance notification (particularly around indicating likely cost and budgetary implications) and asked that Lilly be advised of its concerns.

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