AUTH/2137/6/08: Consultant dermatologist v Ranbaxy – Co-Cyprindiol ‘Dear Sir or Madam’ letter (no breach)

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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	Allegation that the letter implied Co-Cyprindiol was a combination of isotretinoin and erythromycin; assessment of whether the information was misleading
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 complainant also said Ranbaxy’s response when contacted was not concerned about potential misinformation, and she presumed the letter had been sent to all practising doctors.
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 prescribing information was on the back of the letter and maintained the information was correct and not misleading.

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The Panel ruled there was no breach of Clause 7.2 because the letter did not state that Co-Cyprindiol contained isotretinoin and erythromycin.
Despite no breach, the Panel considered the complainant had been misled and that the drafting of the letter could have been clearer.
The Panel noted the letter itself did not state the active ingredients of Co-Cyprindiol; the only reference to cyproterone acetate and ethinyloestradiol was in the prescribing information on the reverse.
The Panel considered that failure to comply with Clause 4.3 (non-proprietary name adjacent to the most prominent display of the brand name) was the root cause of the confusion, but no allegation had been made under Clause 4.3 so the Panel made no ruling on it.
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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