AstraZeneca and Genzyme have been named and shamed in advertisements for separate breaches of the Association of the British Pharmaceutical Industry’s Code of Practice.
The ABPI’s policing arm, the Prescription Medicines Code of Practice Authority, ruled that AZ breached three clauses of the Code by producing a leavepiece which provided misleading instructions on how to use the EMIS Web clinical system – which allows healthcare professionals to record, share and use vital information – such that controlled type 2 diabetic patients might be inappropriately treated with its Forxiga (dapagliflozin).
In its actions, the company breached Clause 3.2 – making claims inconsistent with the SPC, Clause 7.2 – making misleading claims, and clause 9.1 – failing to maintain high standards, the PMCPA said.
“The Appeal Board considered that it was fundamental for effective self-regulation for companies to provide accurate information to the Panel and for failing to do so, and for exercising poor governance, it publicly reprimanded AstraZeneca, and also required the firm to issue a corrective statement to recipients of the leavepiece to clarify the position”, the regulator noted.
Elsewhere, Genzyme was found be in breach of a stream of Code clauses after making a presentation about Fabrazyme (agalsidase beta) to an expert advisory group, that the PMCPA says was, “misleading, inconsistent with the Fabrazyme SPC and disparaging of a competitor product”.
The complaint was logged by rival drugmaker Shire, which took issue over material used by Genzyme compared Fabrazyme with its Replagal (agalsidase alfa), both of which were indicated for long-term enzyme replacement therapy in patients with confirmed diagnosis of Fabry Disease.
“The Code of Practice Appeal Board was so concerned about the content of the presentation, its potential effects and impression given including the disregard for patient safety, that it decided to require Genzyme to issue a corrective statement to all of those who had been at the meeting or had received a pre-meeting copy of the material.
The advertisements will appear in the British Medical Journal on 2 July, the Nursing Standard on 6 July and The Pharmaceutical Journal on 30 July.
Last week Astellas’ membership of the ABPI was suspended for one year following “serious breaches” of the Code relating to its conduct surrounding an advisory group meeting and related complaint.
