Stiefel: Duac promotion—misleading indication via acne grading chart, unsubstantiated “within a week” claim, and disguised journal insert (AUTH/2244/6/09)

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Key facts

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Case number	AUTH/2244/6/09
Complainant	A general practitioner and a pharmacist
Company	Stiefel Laboratories Ltd
Medicine	Duac Once Daily Gel (clindamycin 1% and benzoyl peroxide 5%)
Indication (as stated)	Treatment of mild to moderate acne vulgaris, particularly inflammatory lesions
Materials	GP leavepiece (DU:7076UK); pharmacist leavepiece (DU:E7156UK); journal ads (DU:E7121UK, DU:E7232UK); abbreviated ads (DU:E7233UK, DU:E7168UK); GP Review Jan 2008 insert (DU:E7120UK)
Complaint received	17 June 2009
Case completed	17 September 2009
Applicable Code year	2008
Breach clauses	3.2, 7.2 (x3), 7.4, 7.10, 9.1, 9.10, 12.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	Appeal by complainants (some points upheld as no breach; reference provision and “works fast” no-breach rulings upheld)

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

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A GP and a pharmacist complained about Stiefel’s promotion of Duac Once Daily Gel (clindamycin 1%/benzoyl peroxide 5%).
Materials included: GP leavepiece (DU:7076UK), pharmacist leavepiece (DU:E7156UK), two journal ads (DU:E7121UK, DU:E7232UK), two abbreviated ads (DU:E7233UK, DU:E7168UK), and a GP Review January 2008 insert (DU:E7120UK).
Complainants also raised concerns about provision of references requested from medical information.
Key issues assessed: (1) acne grading chart potentially implying use in severe acne, (2) speed-of-action claims (“works fast” vs “starts working within a week”), (3) “can be worn under make-up”, and (4) whether the GP Review insert was promotional/disguised promotion and whether sponsorship was adequately described.

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Breach found for the GP leavepiece acne grading chart: inconsistent with SPC/indication and misleading about licensed indication; did not encourage rational use.
No breach for provision of references (Clause 7.7): references were posted within seven working days; address error did not constitute a breach; upheld on appeal.
No breach for “Duac Once Daily Gel works fast”: considered substantiated and not misleading/exaggerated; upheld on appeal.
Breach found for “can be worn under make-up”: misleading as it did not reflect evidence; no clinical data supported concomitant use.
No breach for “No need to keep it in the fridge” (in GP leavepiece for non-dispensing prescribers): interpreted as patient-use storage context.
Breach found for “Duac… starts working within a week”: misleading and unsubstantiated because evidence showed effects at week 1, not <7 days.
Breach found for GP Review insert: inadequate description of company involvement (“Provided as a service to medicine by Stiefel” not accurate), held to be disguised promotion, and high standards not maintained.

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