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AUTH/2442/10/11

Case number:AUTH/2442/10/11
Case ref:Pharmacosmos v Vifor
Description:Breach of undertaking
Breach:Breaches Clauses 2, 9.1 and 25
Appeal:No appeal
Review:Published in the May 2012 Review
Received:11/10/2011
Completed:18/11/2011
Case Summary:

​Pharmacosmos AS alleged that Vifor Pharma UK had breached its undertaking given in Case AUTH/2422/7/11 by using the claim ‘Ferinject avoids dextran-induced hypersensitivity reactions’ in two press releases which were available on the company’s website in October 2011.

Pharmacosmos noted that the claim had been ruled in breach of the Code because it wrongly implied that Ferinject was free of hypersensitivity reactions. The undertaking given in Case AUTH/2422/7/11 was dated 30 August 2011. One press release, dated 13 June, was about the approval by the Scottish Medicines Consortium (SMC) for the use of Ferinject for the treatment of iron deficiency anaemia. The other was about the Medicines and Healthcare products Regulatory Agency (MHRA) approval for a simplified dosing regimen for the treatment of iron deficiency.

The case was taken up by the Director as the Authority was responsible for ensuring compliance with undertakings.

The detailed response from Vifor is given below.

The Panel noted that an undertaking was an important document. It included an assurance that all possible steps would be taken to avoid similar breaches of the Code in future. It was very important for the reputation of the industry that companies complied with undertakings.

In Case AUTH/2422/7/11 the claim at issue, ‘Ferinject avoids dextran-induced hypersensitive reactions’ had appeared in a leavepiece. In that case, the Panel noted that Section 4.4 of the Ferinject SPC, Special warnings and precautions for use, stated that ‘Parenterally administered iron preparations can cause hypersensitivity reactions including anaphylactoid reactions, which may be potentially fatal …. Therefore, facilities for cardio-pulmonary resuscitation must be available’. Section 4.8, Undesirable effects listed hypersensitivity including anaphylactoid reactions as an uncommon side effect. The only reference to this possible side effect to Ferinject in the leavepiece at issue was in the prescribing information. The Panel did not accept Vifor’s submission that the prescribing information on the back page of the leavepiece provided all the relevant safety information about hypersensitivity reactions. Claims in promotional material had to be capable of standing alone without reference to, inter alia, prescribing information to correct an otherwise misleading impression.

The Panel did not accept Vifor’s submission in Case AUTH/2422/7/11 that the potential for hypersensitivity reactions with Ferinject per se was a separate issue. The claim at issue highlighted theissue of hypersensitivity reactions and in the Panel’s view, without a counter-balancing statement with regard to the possibility of hypersensitivity reactions with Ferinject, sought to minimise the prescriber’s concerns about such reactions and in that regard might compromise patient safety. A breach of the Code was ruled.

Turning to Case AUTH/2442/10/11, the Panel considered that the claim that Ferinject was ‘…not associated with dextran-induced hypersensitivity reactions’ in the MHRA approval press release was covered by the undertaking in Case AUTH/2422/7/11 although unlike the leavepiece, the press release was not aimed solely at prescribers. The claim highlighted the issue of hypersensitivity reactions and in the Panel’s view, without a counter-balancing statement with regard to the possibility of hypersensitivity reactions with Ferinject, sought to minimise the concerns about such reactions. A breach of the Code was ruled as acknowledged by Vifor.

Although the claim in the SMC approval press release that Ferinject was ‘…not associated with dextran-induced hypersensitivity reactions since it is free of dextran and dextran derivatives…’ gave more details it again implied that there was no need to be concerned about hypersensitivity reactions with Ferinject. In the Panel’s view this was similarly covered by the undertaking in Case AUTH/2422/7/11. A breach of the Code was ruled as acknowledged by Vifor.

The Panel considered that high standards had not been maintained and ruled a breach of the Code. The Panel considered that failing to comply with the undertaking brought discredit upon and reduced confidence in the pharmaceutical industry. A breach of Clause 2 was ruled.