Ferring voluntary admission: uncertified Pentasa conference programme ad with misleading indication and “excellent efficacy” claim

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Key facts

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Case	AUTH/2293/1/10
Company	Ferring Pharmaceuticals Ltd
Product	Pentasa (mesalazine)
Material	Abbreviated advertisement in Gastro 2009 conference programme
Conference	Gastro 2009 (independent gastroenterology conference), London, 21–25 November 2009
How issue arose	Placed by Swiss global marketing; draft sent as “place holder”; agency handover lapse; not tracked; printed without UK certification
Key problematic claims/text	“the power of five in ulcerative colitis”; “Celebrate PODIUM – a study demonstrating excellent clinical efficacy”; AE statement missing company-reporting sentence
Complaint received / proceedings commenced	11 January 2010
Completed	24 February 2010
Applicable Code year	2008
Breach clauses	3.2, 5.6, 7.2 (x2), 7.4, 7.10, 9.1
Clause 2	Not breached
Sanction	Undertaking received
Appeal	No appeal

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

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Ferring voluntarily admitted an abbreviated advertisement for Pentasa (mesalazine) in the Gastro 2009 conference programme (London, 21–25 Nov 2009) breached the Code.
The ad was placed by global marketing colleagues in Switzerland and was not put through the UK approval/certification procedure.
A draft version was sent as a “place holder” by a UK advertising agency; a personnel change and handover lapse meant the draft was printed without UK final sign-off.
The headline “the power of five in ulcerative colitis” did not adequately describe the UK licensed indications (generally mild to moderate ulcerative colitis; plus specific indications for tablets/enema), and was considered misleading/inconsistent with the SPCs.
The adverse event reporting statement omitted the required final sentence to report AEs to the company.
The claim “Celebrate PODIUM – a study demonstrating excellent clinical efficacy” was considered ambiguous, exaggerated and not substantiated.

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The voluntary admission was treated as a complaint because it involved serious matters (failure to certify and promotion inconsistent with the SPC).
Breaches were ruled for Clauses 3.2, 5.6, 7.2 (x2), 7.4, 7.10 and 9.1.
No breach was ruled for Clause 2 (the Panel did not consider the circumstances warranted particular censure).
Proceedings commenced: 11 January 2010.
Case completed: 24 February 2010.
No appeal.

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