AUTH/2758/5/15: Galen v Stirling Anglian — CosmoCol abbreviated ad and leavepiece breaches (pack/cost info and missing active ingredients) | PMCPA Case

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Key facts

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Case number	AUTH/2758/5/15
Parties	Galen v Stirling Anglian Pharmaceuticals
Product	CosmoCol (Macrogol 3350 plus electrolytes)
Indication (as stated)	Treatment of chronic constipation and faecal impaction
Materials	MIMS advertisement (March 2015; ref 00010010005 1.0) and leavepiece (February 2015; ref 00010010006 1.0)
Main issues	Abbreviated ad contained pack size/cost and other claims so should have included prescribing information; ad and leavepiece did not list active ingredients as per SPC
Applicable Code	2015
Breach clauses	Clause 4.3, Clause 5.2, Clause 5.4
Complaint received	12 May 2015
Case completed	12 August 2015
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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Galen complained about Stirling Anglian’s promotion of CosmoCol (Macrogol 3350 plus electrolytes) via (1) an “abbreviated advertisement” in MIMS (March 2015) and (2) a one-page leavepiece (prepared February 2015).
The MIMS ad (ref 00010010005 1.0) showed pack shots and included pack size and cost details, plus claims such as “lowest cost”, taste claims, and a dosage-related claim (“highly versatile half-dose”).
Both the ad and leavepiece used the heading “CosmoCol Macrogol 3350. Powder for oral solution”.
Galen alleged the ad could not qualify as an abbreviated advertisement because it included pack size/cost, and that “macrogol 3350” alone did not meet the requirement to provide the non-proprietary name/list of active ingredients (which per SPC included macrogol 3350 plus electrolytes).
Galen also alleged the leavepiece failed to include the non-proprietary name/list of active ingredients adjacent to the brand name.
Stirling Anglian argued pack size/cost were part of the “reason why the medicine was recommended” and said the wording used had been approved by the MHRA at licensing; it also revised materials to list all active ingredients.

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The Panel ruled the MIMS material went beyond what is permitted for an abbreviated advertisement; it therefore required prescribing information and breached the Code.
The Panel ruled both the abbreviated advertisement and the leavepiece failed to list the active ingredients as reflected in the SPC.
No appeal.

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