Anonymous v Bayer: ‘Prescribing Policy’ mailer for Levitra ruled promotional and missing prescribing information (AUTH/2333/7/10)

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Key facts

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Case number	AUTH/2333/7/10
Company	Bayer Schering Pharma
Complainant	Anonymous (non contactable)
Medicine	Levitra (vardenafil)
Material	Four-page document: ‘Prescribing Policy: Vardenafil as first choice for erectile dysfunction’
Audience	Medicines managers in primary care organisations (PCOs)
Distribution	Bayer distributed to 1,665 medicines managers (later found circulated more widely than previously indicated)
Main issue	Promotional material sent without prescribing information
Applicable Code year	2008
Breach clause(s)	Clause 4.1
Complaint received	15 July 2010
Undertaking received	8 September 2010
Appeal hearing	No appeal (Report from Panel to the Appeal Board)
Appeal Board consideration dates	22 September 2010; 10 November 2010; 17 March 2011
Interim case report published	29 October 2010
Case completed	17 March 2011
Sanctions applied	Undertaking received; Advertisement; Audit of company’s procedures; Recovery of items; Public reprimand; Re-audit

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous complainant received an unsolicited four-page document titled ‘Prescribing Policy: Vardenafil as first choice for erectile dysfunction’, stated as supported by an educational grant from Bayer Schering Pharma (marketer of Levitra (vardenafil)).
The complainant said no prescribing information was enclosed, despite the document referring to Levitra and its licensed indication.
Bayer said a third-party consultancy initiated and coordinated the document for medicines managers in primary care organisations (PCOs), and argued it was informational (not promotional), not certified, and therefore did not include prescribing information.
The Panel reviewed the arrangements and found the consultancy effectively acted as Bayer’s agent: Bayer accepted a commercial proposal to create guidance on Levitra, provided a vardenafil price list, requested and screened the mailing list, and distribution by Bayer “in the field” was envisaged.
The Panel considered the document clearly promotional (objectives included placing Levitra as first choice PDE5 inhibitor and advocating switches), so it should have included prescribing information.
The Panel also expressed serious concern about the document’s content (eg “first choice”, “safe option”, and an implication that NICE recommended vardenafil), although the formal allegation was about missing prescribing information.

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Breach ruled: Clause 4.1 (absence of prescribing information on promotional material).
Case reported by the Panel to the Code of Practice Appeal Board under Paragraph 8.2 of the Constitution and Procedure due to concerns about judgement, understanding of the Code, and control of promotional material.
Appeal Board required an Authority audit of Bayer’s procedures and required Bayer to attempt recovery of the document from recipients.
Following the October 2010 audit report, the Appeal Board publicly reprimanded Bayer for failing to provide comprehensive/accurate information about the extent of circulation.
A further re-audit was required (February 2011). After reviewing the February 2011 audit report, the Appeal Board decided no further action was required.

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