Bayer guilty of multiple Code breaches
Bayer Healthcare has admitted to 12 breaches of the ABPI Code after one of its staff developed and distributed drug information without the company’s knowledge.
In a highly embarrassing move, Bayer revealed that three documents relating to Bayer’s oral anticogulant Xarelto (rivaroxaban) were not submitted for review and certification (breaching clause 14.1).
The first the company knew of the imbroglio was when a service improvement manager for an NHS heart and stroke network wrote to Bayer with her concerns about a proposal for joint working she had received.
In essence, she thought it was promotional, contained costs and claims information was not accurate, and had comparative claims which were not accurate, fair or based on data (thus falling foul of clauses 7.2, 7.3 and 7.4).
As if this were not enough, there was also reference in the documents to future indications and ‘out of licence claims’ (in direct contravention of clause 3.1).
A panel of the PMCPA, which enforces the Code, said the circulation of such “poor quality documents which contained multiple errors, including misleading statements with regard to patient safety” was enough to breach clause 2 (bringing discredit upon or reducing confidence in, the pharma industry) – the most serious charge under the Code.
One document, a draft patient pathway, even referred to ‘arterial’ fibrillation rather than atrial fibrillation – the condition for which Xarelto is indicated, demonstrating the shoddy state of the documents.
Bayer investigates own practice
Bayer’s subsequent investigation found that the employee in question had worked on two projects: the first was with the medicines management team to develop a business case for Xarelto’s inclusion on a PCT’s formulary.
The second was on the development of a patient access pathway for introducing the new non-vitamin K antagonist oral anticoagulants.
The content of the business case, the project initiation document and the draft pathway prompted the complainant’s letter to Bayer – the PMCPA panel thought these were in effect an inducement to prescribe Xarelto.
The documents also contained no prescribing information (as they should according to clause 4.1), no reference to adverse event reporting (4.10) and no inverted black triangle (4.11).
It was not clear that Bayer had originated the documents, thus making the company guilty of disguised promotion (12.1).
While it was true that the documents had not been approved by Bayer, a draft of the business case had in fact been seen by a line manager in October last year – but no action to ensure it was approved was taken.
The panel felt this meant the employee who distributed the information and Bayer itself had both failed to maintain high standards (clauses 15.2 and 9.1).
Bayer did not appeal – the judgment is to be published in next month’s PMCPA review.
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