AUTH/2231/5/09: Bayer v Boehringer Ingelheim – medical information letter and congress stand promoted Pradaxa off-label | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/2231/5/09
Complainant	Bayer plc
Respondent	Boehringer Ingelheim Limited
Product	Pradaxa (dabigatran)
Competitor product referenced	Xarelto (rivaroxaban)
Issue(s)	Medical information letter content (including unlicensed indication reference, comparative bleeding statements, epidural catheter wording) and congress stand content about clinical trial programme/unlicensed indications; prescribing information availability
Meeting/setting	British Society for Haematology, 49th Annual Scientific Meeting, 27–29 April 2009 (stand)
Complaint received	18 May 2009
Case completed	14 September 2009
Applicable Code year	2008
Appeal	No appeal
Breach clause(s)	3.2 (x3), 4.1, 7.2 (x2), 8.1 and 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

Bayer complained about Boehringer Ingelheim’s promotion of Pradaxa (dabigatran).
Two items were at issue: (1) a medical information letter sent by Boehringer Ingelheim’s medical information department to a health professional; and (2) information provided on a Boehringer Ingelheim stand at the British Society for Haematology (BSH) meeting (April 2009).
Pradaxa was licensed for primary prevention of venous thromboembolic events (VTE) in adults after elective total hip or knee replacement surgery; Bayer’s Xarelto (rivaroxaban) was similarly licensed.
The letter’s opening framed the topic as “available oral agents for VTE thromboprophylaxis” in hip/knee replacement, but later included an “Ongoing studies” section referencing stroke prevention in atrial fibrillation (SPAF) and other development areas (unlicensed for Pradaxa at the time).
The letter included comparative commentary about Xarelto and bleeding risk (including wording that pooled bleed data “shows significance”), and guidance about epidural catheters that did not match the Pradaxa SPC wording.
At BSH, Boehringer operated a separate stand (manned by medical affairs/medical information) presenting the REVOLUTION clinical trial programme (including unlicensed indications such as acute VTE treatment, secondary VTE prevention, SPAF, and secondary prevention of cardiac events in acute coronary syndrome). The stand stated medical information was available “on request” and displayed trial logos/panels.

⚖️

⌄

The Panel ruled that parts of the medical information letter constituted promotion outside the marketing authorisation and contained misleading/disparaging content.
The Panel ruled that the BSH stand solicited enquiries and promoted Pradaxa for unlicensed indications; prescribing information should have been provided or made available.
No breach of Clause 2 was ruled (for either the letter or the stand), despite the Panel being seriously concerned about the stand.
No breach of Clause 25 was ruled (inter-company dialogue undertakings are not undertakings to the Authority under Clause 25).
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access