Boehringer Ingelheim Pradaxa website: prescribing information not signposted on first HCP landing page (Clause 4.6)

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Key facts

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Case number	AUTH/2444/10/11
Complainant	General practitioner
Company	Boehringer Ingelheim Limited
Product	Pradaxa (dabigatran)
Material	Pradaxa.co.uk website (HCP and patient/public sections)
Complaint received	19 October 2011
Case completed	19 January 2012
Applicable Code year	2011
Breach clauses	Clause 4.6
No breach clauses	Clauses 7.2, 22.1, 22.2, 24.1
Appeal	Yes (by complainant); unsuccessful (no breach of 22.1 and 22.2 upheld)
Sanctions	Undertaking received

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

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A general practitioner complained about Boehringer Ingelheim’s Pradaxa (dabigatran) website (Pradaxa.co.uk).
The complaint alleged the HCP section was not sufficiently access-restricted and effectively facilitated promotion of a prescription-only medicine to the public.
The complaint also alleged the stroke prevention in atrial fibrillation (SPAF) section was misleading because it did not reference the 75mg dose.
The complaint further alleged that the location of prescribing information was only clarified after prominent promotional content appeared.

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No breach of Clause 22.1 (advertising POMs to the public) regarding the open-access HCP material; upheld on appeal.
No breach of Clause 22.2 (information to the public) regarding the access arrangements; upheld on appeal.
No breach of Clause 24.1 in relation to the access arrangements (Panel ruling; Appeal Board did not need to consider after upholding no breach of 22.1/22.2).
No breach of Clause 7.2 regarding omission of the 75mg dose in the SPAF section.
Breach of Clause 4.6 because the first HCP page (after confirming HCP status) referred to licensed indications but did not indicate where prescribing information could be found.

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