Shire v Procter & Gamble: Asacol strapline “confidence in colitis” ruled inconsistent with SPC; unqualified HCP quote on switching also misleading (AUTH/2267/9/09)

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Key facts

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Case number	AUTH/2267/9/09
Parties	Shire Pharmaceuticals Ltd v Procter & Gamble Pharmaceuticals UK, Limited
Product	Asacol (modified release mesalazine)
Materials	Dosing leavepiece (AS7709/56655); Journal advertisement (AS7965/58698.02); Prescribing leavepiece (AS7927/58854.04)
Main issues	Unqualified strapline “confidence in colitis” implying broader use than SPC; unqualified HCP quote implying patients should not be switched
Applicable Code year	2008
Complaint received	15 September 2009
Case completed	04 November 2009
Appeal	No appeal
Breach clauses	Clauses 3.2 and 7.2
Sanction	Undertaking received

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

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Shire complained about Procter & Gamble promotional materials for Asacol (modified release mesalazine): two leavepieces and a journal advertisement.
Asacol’s indications included treatment of mild to moderate acute exacerbations of ulcerative colitis and maintenance of remission; also maintenance of remission in Crohn’s ileocolitis.
A dosing leavepiece and a journal advertisement used the strapline “confidence in colitis” beneath/within the product logo; Shire argued this was insufficiently qualified and implied use across all “colitis”.
A separate prescribing leavepiece included a named doctor’s quote stating patients “should not be switched” and should be kept on their existing brand of mesalazine; Shire argued this was misleading and not balanced.
Shire also challenged the journal ad claims “Back to normal everyday life… sooner” and “Great news” as unsubstantiable/exaggerated/poor taste.

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Breach: Clause 3.2 (strapline “confidence in colitis” implied broader use than the SPC; insufficient qualification of the disease state).
No breach: Clause 7.10 in relation to the word “confidence” implying special merit/superlative (Panel did not agree it implied special merit).
No breach: Journal ad claims “Back to normal everyday life… sooner” and “Great news” (no breach of Clauses 7.2, 7.3, 7.10 and 9.1 as considered by the Panel in this context).
Breach: Clause 7.2 (unqualified doctor quote about not switching was misleading; did not reflect balance of evidence and omitted the caveat about switching for clinical reasons).

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