Roche voluntary admission: Avastin BMJ ad published before final certification (AUTH/2271/10/09)

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Key facts

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Case number	AUTH/2271/10/09
Company	Roche Products Limited
Product	Avastin (bevacizumab)
Material	Journal advertisement (AVAB00055a)
Channel	BMJ (published throughout September)
Issue	Advertisement published before final certification due to misunderstanding of certification procedure
Complaint received	02 October 2009
Case completed	04 November 2009
Applicable Code year	2008
Breach clauses	9.1 and 14.1
No breach	Clause 2
Sanctions	Undertaking received
Appeal	No appeal

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

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Roche voluntarily admitted that an advertisement for Avastin (bevacizumab) was published in the BMJ throughout September before it had been fully certified.
The failure occurred because a single employee misunderstood the final certification process for journal advertisements after returning from a leave of absence.
A line manager identified the issue when asked to sign the job bag containing the published advertisement.
Roche explained that for journal ads the colour PDF proof sent to printers (including cutter guide and exact dimensions) should be finally certified, not the final printed journal.
Once identified, Roche certified the advertisement, added the certification form and a file note to the job bag, and reported the matter to the compliance team and head of medical affairs.
Roche briefed marketing teams (presentation at a marketing meeting; email from the medical director) and planned a journal advertising guideline with agencies to prevent recurrence.

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The Director treated the voluntary admission as a complaint because failure to certify was considered a serious matter.
Breach of Clause 14.1 was ruled (acknowledged by Roche).
Breach of Clause 9.1 was ruled because publishing prior to certification meant high standards had not been maintained.
No breach of Clause 2 was ruled; the Panel did not consider the circumstances warranted that level of censure.
No appeal.

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