Case Summary
A consultant dermatologist complained that a 'Dear Sir or Madam' letter about Co-Cyprindiol (cyproterone acetate and ethinyloestradiol), sent by Ranbaxy, stated that Co-Cyprindiol was a combination of isotretinoin 20mg with erythromycin 250mg. Bearing in mind that Co- Cyprindiol was specifically named in the National Institute for Health and Clinical Excellence (NICE) guidelines for the treatment of acne in women prior to referral to a consultant dermatologist, the complainant was worried if it really did contain isotretinoin and erythromycin.
The Panel noted that the letter stated that Co- Cyprindiol was an addition to Ranbaxy's dermatology portfolio which consisted of isotretinoin 20mg capsules (30 pack) and erythromycin 250mg tablets (28 pack). It did not state that Co-Cyprindiol contained isotretinoin and erythromycin. Although the Panel ruled that there had been no breach of the Code it nonetheless considered that the letter could have been clearer.
CASE AUTH/2137/6/08 CONSULTANT DERMATOLOGIST v RANBAXY
No breach of the Code
Co-Cyprindiol ‘Dear Sir or Madam’ letter
A consultant dermatologist complained that a ‘Dear Sir or Madam’ letter about Co-Cyprindiol (cyproterone acetate and ethinyloestradiol), sent by Ranbaxy, stated that Co-Cyprindiol was a combination of isotretinoin 20mg with erythromycin 250mg. Bearing in mind that CoCyprindiol was specifically named in the National Institute for Health and Clinical Excellence (NICE) guidelines for the treatment of acne in women prior to referral to a consultant dermatologist, the complainant was worried if it really did contain isotretinoin and erythromycin.
The Panel noted that the letter stated that CoCyprindiol was an addition to Ranbaxy’s dermatology portfolio which consisted of isotretinoin 20mg capsules (30 pack) and erythromycin 250mg tablets (28 pack). It did not state that Co-Cyprindiol contained isotretinoin and erythromycin. Although the Panel ruled that there had been no breach of the Code it nonetheless considered that the letter could have been clearer.
A consultant dermatologist complained about a ‘Dear Sir or Madam’ letter about Co-Cyprindiol (cyproterone acetate and ethinyloestradiol) which she had received from Ranbaxy Europe Ltd.
COMPLAINT
The complainant stated that the letter said that CoCyprindiol was a combination of isotretinoin 20mg with erythromycin 250mg. Bearing in mind that CoCyprindiol was specifically named in the National Institute for Health and Clinical Excellence (NICE) guidelines for the treatment of acne in women prior to referral to a consultant dermatologist, the complainant thought it was very worrying if it really did contain isotretinoin and erythromycin.
Perhaps this was a typographical error but the complainant found Ranbaxy’s attitude, which she contacted first, very worrying in that it was not in the least bit concerned that there might be some gross misinformation in the letter, which the complainant presumed had been sent to all practising doctors.
When writing to Ranbaxy, the Authority asked it to respond in relation to Clause 7.2 of the Code.
RESPONSE
Ranbaxy stated that the letter, which had been sent to consultant dermatologists, stated that ‘CoCyprindiol will be a new addition to our dermatology portfolio, which consists of Isotretinoin 20mg capsules (30 pack) and Erythromycin 250mg tablets (28 pack)’. Ranbaxy currently had these two products on the market for treatment of dermatological conditions, and was simply notifying physicians about the additional availability of Co-Cyprindiol. The letter did not state that Co-Cyprindiol was a combination of isotretinoin and erythromycin, as it clearly was not. The letter had prescribing information on the back of it.
Ranbaxy believed that the information was correct and not misleading, and did not breach Clause 7.2.
PANEL RULING
The Panel noted that the letter stated that CoCyprindiol was an addition to Ranbaxy’s dermatology portfolio which consisted of isotretinoin 20mg capsules (30 pack) and erythromycin 250mg tablets (28 pack). It did not state that Co-Cyprindiol contained isotretinoin and erythromycin.
The Panel accordingly ruled that there had been no breach of Clause 7.2.
Nonetheless, the complainant had been misled and the Panel considered that the drafting of the letter could have been clearer. The letter 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. In that regard the Panel noted that Clause 4.3 of the Code required the non-proprietary name of a medicine to appear immediately adjacent to the most prominent display of the brand name.
The supplementary information stated that in a promotional letter the most prominent display of the brand name would usually be that in the letter itself, rather than in the prescribing information on the reverse of the letter. The Panel considered that the failure to comply with Clause 4.3 had been the root cause of the confusion caused by the letter. No allegation had been made in this regard and thus the Panel could make no ruling. The Panel further considered that prescribing information should have been provided for both isotretinoin and erythromycin. The Panel asked that Ranbaxy be advised of its views on these points.
Complaint received 30 June 2008
Case completed 30 July 2008
