AUTH/2268/9/09: Cephalon/Director v ProStrakan — Abstral ad re-published despite undertakings (BMJ) | PMCPA Case

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Key facts

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Case number	AUTH/2268/9/09
Parties	Cephalon/Director v ProStrakan
Product	Abstral (sublingual fentanyl citrate)
Material	Advertisement (ref MO17/0134) in the BMJ (12 September 2009)
Issue	Re-publication of an advertisement previously subject to undertakings; insufficiently robust withdrawal process
Applicable Code year	2008
Complaint received	16 September 2009
Case completed	30 October 2009
Appeal	No appeal
Breach clauses	Clause 9.1 and Clause 25
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Cephalon complained that a ProStrakan advertisement for Abstral (sublingual fentanyl citrate) appeared in the BMJ on 12 September 2009, despite undertakings given in earlier cases (AUTH/2207/2/09 and AUTH/2235/5/09).
Because the complaint alleged breach of undertakings, it was taken up by the Director (PMCPA responsibility to ensure compliance with undertakings).
ProStrakan said it used multiple agencies (media buying and advertising agencies) and had instructed withdrawal after the AUTH/2235/5/09 ruling, including emailing journals on 26 June 2009 to delete the ad and related materials.
ProStrakan discovered on 16 September 2009 that the withdrawn ad had nevertheless been used in the 12 September BMJ issue; it immediately notified the PMCPA and initiated an investigation via its buying agency.
The BMJ acknowledged the ad was out of date and stated the incorrect use was due to an issue at the BMJ (human error).
The Panel noted the withdrawal email did not state why the ad was being withdrawn and (with one exception) ProStrakan/its agent did not request written confirmation of receipt, withdrawal, and destruction/deletion of file copies.

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Breach of Clause 25 ruled (failure to comply with an undertaking).
Breach of Clause 9.1 ruled (procedures for withdrawing material not sufficiently robust; high standards not maintained in that regard).
No breach of Clause 2 ruled in this case (Panel considered ProStrakan made some effort and was badly let down by the BMJ; circumstances did not warrant Clause 2).
No appeal.

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