AUTH/2698/1/14: Astellas – misleading sponsorship declaration in BMJ supplement (Vesomni launch) | PMCPA Case

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Key facts

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Case number	AUTH/2698/1/14
Company	Astellas Pharma
Case type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Complaint received	30 January 2014
Case completed	16 April 2014
Appeal	No appeal
Material	Lower Urinary Tract Symptoms (LUTS) Consensus Statement (“Medicine matters” supplement)
Channel/distribution	Distributed as a supplement with the BMJ
Product(s) referenced	Vesomni (tamsulosin HCl/solifenacin succinate); prescribing information also included for Betmiga (mirabegron)
Main issue	Front-cover sponsorship declaration understated Astellas’ involvement and was not sufficiently prominent/unambiguous; created impression of independent consensus
Process issue	Certified and sent to print before MHRA pre-vetting comments were received
Breach clauses	9.1, 9.10, 12.1
Sanctions	Undertaking received; additional sanctions not stated

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

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What happened

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Astellas Pharma voluntarily admitted an error in the declaration of sponsorship on the front cover of a promotional item: a “Lower Urinary Tract Symptoms (LUTS) Consensus Statement” linked to the launch of Vesomni (tamsulosin HCl/solifenacin succinate).
The item was distributed as a supplement with the BMJ.
The front cover sponsorship line stated: “This edition is funded and has been checked for factual accuracy by Astellas Pharma Ltd”.
In the acknowledgements (page 7), the document stated the consensus group meeting was organised and funded by Astellas; editorial support was provided by a communications agency; and final content was reviewed by Astellas.
MHRA pre-vetting applied: a cessation of vetting notice (2 December 2013) required the consensus statement to be submitted to MHRA before use.
Due to human error, the item was certified (13 January 2014) and sent to print before submission to MHRA (17 January 2014) and before MHRA comments were received (22 January 2014).
MHRA requested the front-page acknowledgement be expanded to state Astellas had been fully involved in initiation, meeting organisation and author nomination.
Astellas attempted a recall, but the supplement had already been distributed with the BMJ; Astellas agreed a corrective statement letter to be circulated with the BMJ on 8 February and to contact individuals who had been handed a copy.
The Panel also criticised Astellas’ submission that MHRA had “no objection to the actual consensus statement”; MHRA had not carried out a detailed review and only stated it would not object in principle, with accuracy remaining Astellas’ responsibility.

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Outcome

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Breach of Clause 12.1 ruled: the presentation and sponsorship wording created the impression of independent clinical consensus and amounted to disguised promotion.
Breach of Clause 9.10 ruled: the sponsorship declaration was not sufficiently prominent/unambiguous and misleadingly implied only arm’s-length funding.
Breach of Clause 9.1 ruled: high standards were not maintained, including certification/printing before MHRA pre-vetting comments.
No appeal.
Undertaking received.

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AUTH/2698/1/14: Astellas – misleading sponsorship declaration in BMJ supplement (Vesomni launch)

Key facts

What happened

Outcome

Clauses

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