Public reprimand for Astrazeneca
Identifying patients suitable for Forxiga treatment and failing to provide an accurate response to the Panel
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Date posted01 May 2016
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SanctionPublic reprimand,
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Case number/s
AstraZeneca UK Limited has been publicly reprimanded by the Code of Practice Appeal Board for providing inaccurate information to the Code of Practice Panel (Case AUTH/2793/9/15).
In Case AUTH/2793/9/15, the Panel ruled breaches of the Code with regard to a leavepiece which provided misleading instructions on how to use the EMIS Web clinical system such that controlled (based on HbA1c levels) type 2 diabetic patients might be inappropriately treated with Forxiga (dapagliflozin). AstraZeneca accepted the Panel’s rulings and provided the requisite undertaking. When informed of the outcome of the case, the complainant noted that AstraZeneca’s response to the Panel was inaccurate with regard to how EMIS could be searched. AstraZeneca initially stood by the information it had submitted but on the provision of further and better particulars from the complainant, it subsequently accepted that the information it had provided was incorrect.
The Panel reported AstraZeneca to the Appeal Board. On consideration of that report the Appeal Board noted that AstraZeneca had relied wholly on the expertise of an agency when drawing up the leavepiece and had demonstrated extremely poor governance in the matter. This was not acceptable. The Appeal Board noted that AstraZeneca had taken full responsibilities for its failings but, nonetheless, considered that it was fundamental for effective self-regulation that companies provide accurate information to the Panel.