Janssen v Boehringer Ingelheim & Lilly: Jardiance EMPA‑REG letter ruled off‑label promotion and disguised promotion

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Key facts

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Case numbers	AUTH/2825/3/16 and AUTH/2826/3/16
Complainant	Janssen-Cilag
Respondents	Boehringer Ingelheim Ltd and Eli Lilly and Company Ltd (the Alliance)
Medicine	Jardiance (empagliflozin)
Material/channel	“Dear UK Healthcare Professional” letter stapled to EMPA-REG reprint and prescribing information; handed out by reps after 1:1 calls
Main issue	Promoted cardiovascular risk reduction outcomes inconsistent with SPC; letter appearance made promotional intent not immediately obvious (disguised promotion)
Complaint received	03 March 2016
Applicable Code year	2016
Breaches	Clauses 2, 3.2, 9.1, 12.1
No breach	Clause 1.12
Scale noted	2,687 health professionals received the material (per Appeal Board)
Corrective statement	Issued 29 July 2016
Case completed	12 October 2017

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

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Janssen-Cilag complained about a two-sided A4 “Dear UK Healthcare Professional” letter (ref UK/EMP/00241) about Jardiance (empagliflozin) cardiovascular outcomes.
The letter was stapled to a reprint of Zinman et al (2015) (EMPA-REG OUTCOME) and a one-sided A4 sheet of Jardiance prescribing information, placed in an envelope and handed out by Alliance representatives after 1:1 Jardiance calls.
Page 1 of the letter had no company name/logo/address and no prominent medicine branding; the envelope was plain.
The most prominent section on page 1 (“Recent Cardiovascular Outcomes Data”) took ~75% of the page and presented efficacy-style CV outcome bullet points (eg 14% relative risk reduction in the primary composite endpoint vs placebo).
The Jardiance SPC at the time only stated in Section 5.1 that empagliflozin “did not increase cardiovascular risk”.
The Alliance had submitted an application to extend the indication to include prevention of cardiovascular events; CHMP had not yet decided.
Representatives were briefed to distribute the pack but not discuss the EMPA-REG study beyond mandatory verbatim, and to direct queries to medical information/medical advisors.

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Breach rulings (upheld on appeal): Clauses 2, 3.2, 9.1 and 12.1.
No breach: Clause 1.12.
The Panel reported the Alliance to the Appeal Board to consider further sanctions due to seriousness (including Clause 2).
The Appeal Board required corrective action, recovery of materials, and audits of both companies’ Code procedures with emphasis on Alliance activities.
Re-audits occurred; ultimately the Appeal Board decided no further action was required after follow-up and improvements.

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