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Bayer faces ABPI audit after "shocking" Levitra error

Published on 05/11/10 at 01:35pm
Bayer's Levitra
The document discussed Levitra in relation to national clinical guidelines, its evidence base and comparative cost savings

Bayer has been accused of a “shocking error of judgement” after promotional material for its erectile dysfunction brand Levitra (vardenafil) breached the ABPI Code of Practice.

In a damning interim report, Code regulator the PMCPA said the company “demonstrated a fundamental lack of understanding of the relevant requirements”. 

Bayer is still awaiting its fate while the PMCPA carries out an audit of its procedures, but the investigating panel said it was “very concerned” and has ordered Bayer to recall as much of the offending material as it can.

The problem stems from a four-page prescribing policy document called “Vardenafil as first choice for erectile dysfunction”, which was sent to medicines managers.

The complainant said he received this unsolicited with no prescribing information enclosed. That falls foul of clause 4.1 of the Code, which states that prescribing information must be on promotional items.

Perhaps more alarming was Bayer’s response to the PMCPA when challenged on the issue: the company said that, as it was sent to medicines managers who were not health professionals per se, the material was not promotional. 

Since promotion is defined in the Code as anything a pharma company does which promotes the prescription, supply, sale or administration of its medicines, this defence did not cut much ice.

The panel pointed out that the Code applied to material directed at “appropriate” administrative staff as well as doctors – and that the status of the intended audience did not in itself determine whether or not the material was promotional.

In addition to this “fundamental lack of understanding”, the appeal board said: “Bayer’s failure to recognise that the document was in fact wholly unacceptable promotional material was a shocking error of judgement.” 

After “briefly” going into the treatment of erectile dysfunction, the document discusses Levitra in relation to national clinical guidelines, its evidence base and comparative cost savings.

The mailing was sent by a third party consultancy, but the panel ruled Bayer had editorial control of its content – and had provided a price list for the drug. 

Bayer had also accepted the consultancy’s proposal to write, secure named authors for, and publish guidance on the use of Levitra – and an agreement between the two parties showed that the document had to be acceptable to Bayer. 

This agreement listed two objectives: to place Levitra as first choice phosphodiesterase inhibitor with primary care organisations and to advocate switches from other such drugs to Levitra. 

Bayer countered that the document was simply distributed on behalf of the authors but the panel’s view was that it was always intended to be distributed by Bayer in the field – thus implying promotional use. 

The PMCPA appeal board is to decide whether further sanctions are necessary when it receives the audit report.

Adam Hill

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