AUTH/2172/10/08: Bayer Schering Pharma – pre-licence promotion of Xarelto via UK congress stand and JBJS supplement | PMCPA Case

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Key facts

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Case number	AUTH/2172/10/08
Parties	Boehringer Ingelheim v Bayer Schering Pharma
Product	Xarelto (rivaroxaban)
Comparator mentioned	Pradaxa (dabigatran)
Main issue	Pre-licence promotion; misleading/disparaging messaging; unacceptable promotional quiz/prize; inadequate sponsorship disclosure; misleading “currently available” graph
Key activities	Exhibition stand at Belfast meeting (June 2008); JBJS insert/supplement distributed in UK (September 2008)
UK marketing authorisation date (Xarelto)	1 October 2008
Complaint received	9 October 2008
Case completed	23 December 2008
Applicable Code	2006 (using 2008 Constitution and Procedure)
Breach clauses	2, 3.1 (x2), 7.2 (x2), 7.3, 8.1, 9.10, 18.2
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

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

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What happened

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Boehringer Ingelheim complained that Bayer Schering Pharma promoted Xarelto (rivaroxaban) before it received a UK marketing authorisation (MA granted 1 October 2008).
At the Irish Orthopaedic Association meeting in Belfast (19–20 June 2008), Bayer Schering had a VTE-themed exhibition stand with panels including: “Great Clinical Need for New Anticoagulants Providing: effective anticoagulation; low risk of bleeding; oral delivery; wide therapeutic window; fixed dosing; no monitoring; low risk of food and drug interactions and predictable pharmacology”.
The stand was manned by sales representatives and marketing team members from the Republic of Ireland affiliate; the UK company said it only learned of the meeting after the event.
A leaflet/quiz card invited delegates to “Test your knowledge on VTE and enter a draw to win a book voucher”.
A supplement on rivaroxaban was distributed with the British Volume of the Journal of Bone and Joint Surgery (available 4 September 2008), before the UK MA. The Panel considered it a paid-for insert linked closely to Bayer Schering (not an arm’s length journal supplement), and not formally peer reviewed by JBJS.
The supplement’s front cover did not clearly acknowledge Bayer Schering’s sponsorship at the outset (disclosures within articles were not considered sufficient).
A graph titled “Efficacy of currently available options for venous thromboembolism prophylaxis” used older data (Geerts et al 2001) and did not include dabigatran, which was available in the UK at the time.

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Outcome

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The exhibition panel at the Belfast meeting was ruled to be pre-licence promotion of Xarelto in a promotional exhibition context.
The “Great Clinical Need…” heading was ruled misleading and disparaging because it implied no anticoagulant was available with the listed attributes (when Pradaxa/dabigatran was already available), and the claimed broader “unmet need” context was not made clear on the panel.
The prize draw quiz was ruled an unacceptable promotional method.
The JBJS insert was ruled promotional and to have promoted Xarelto to UK health professionals prior to MA.
The “currently available options” graph was ruled misleading because it was not up-to-date and omitted dabigatran.
Failure to clearly state sponsorship on the front cover was ruled a breach.
Overall, repeated pre-licence promotion and poor control (including overseas affiliate activity in the UK) brought the industry into disrepute.
No breach was ruled for certain wording allegations (eg, “An introduction to rivaroxaban…” implying availability; and some “offers/will offer” statements being misleading/exaggerated), though the Panel noted that where such statements promoted Xarelto, this was covered by the Clause 3.1 breach.

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AUTH/2172/10/08: Bayer Schering Pharma – pre-licence promotion of Xarelto via UK congress stand and JBJS supplement

Key facts

What happened

Outcome

Clauses

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