AUTH/2137/6/08: Consultant dermatologist v Ranbaxy Europe Ltd – Co-Cyprindiol ‘Dear Sir or Madam’ letter | PMCPA Case

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Key facts

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Case number	AUTH/2137/6/08
Case reference	Consultant dermatologist v Ranbaxy
Complainant	Consultant dermatologist
Respondent/company	Ranbaxy Europe Ltd
Product(s)	Co-Cyprindiol (cyproterone acetate and ethinyloestradiol); isotretinoin 20mg capsules; erythromycin 250mg tablets
Material/channel	‘Dear Sir or Madam’ promotional letter (sent to consultant dermatologists)
Key issue	Whether the letter misleadingly implied Co-Cyprindiol was a combination of isotretinoin and erythromycin; clarity of ingredient presentation and placement of non-proprietary name
Dates (received/completed if stated)	Complaint received 30 June 2008; case completed 30 July 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	No breach of Clause 7.2; Clause 4.3 discussed but no ruling made
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A consultant dermatologist complained about a ‘Dear Sir or Madam’ letter from Ranbaxy Europe Ltd about Co-Cyprindiol (cyproterone acetate and ethinyloestradiol).
The complainant believed the letter stated Co-Cyprindiol was a combination of isotretinoin 20mg and erythromycin 250mg, and was concerned given NICE guidance referenced Co-Cyprindiol for acne in women prior to referral.
The Authority asked Ranbaxy to respond in relation to Clause 7.2.
Ranbaxy said the letter stated Co-Cyprindiol would be a new addition to its dermatology portfolio, which consisted of isotretinoin 20mg capsules (30 pack) and erythromycin 250mg tablets (28 pack), and that it did not state Co-Cyprindiol contained those products.
Ranbaxy stated the letter had prescribing information on the back.

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The Panel found the letter did not state that Co-Cyprindiol contained isotretinoin and erythromycin.
No breach of Clause 7.2 was ruled.
The Panel nonetheless considered the complainant had been misled and that the drafting of the letter could have been clearer.
The Panel noted the letter did not state the active ingredients of Co-Cyprindiol in the letter itself; the only reference to cyproterone acetate and ethinyloestradiol was in prescribing information on the reverse.
The Panel noted Clause 4.3 required the non-proprietary name to appear immediately adjacent to the most prominent display of the brand name, and considered failure to comply with Clause 4.3 was the root cause of confusion, but no allegation had been made so it could make no ruling.
The Panel further considered prescribing information should have been provided for both isotretinoin and erythromycin.
The Panel asked that Ranbaxy be advised of its views on these points.

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Clause 7.2: No breach (Panel ruled the letter did not state Co-Cyprindiol contained isotretinoin and erythromycin).
Clause 4.3: Discussed by the Panel as relevant to the confusion (non-proprietary name adjacent to the most prominent brand name), but no ruling made because no allegation was raised under this clause.

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