AUTH/2263/9/09: Bristol-Myers Squibb v Boehringer Ingelheim — Viramune ‘Have you heard?’ journal ad and ArTEN study (unlicensed dosing) | PMCPA Case

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Key facts

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Case number	AUTH/2263/9/09
Complainant	Bristol-Myers Squibb Pharmaceuticals Limited
Respondent	Boehringer Ingelheim Limited
Product	Viramune (nevirapine)
Material	Journal advertisement (ref NVP3846) in HIV Medicine, July 2009
Main issue	Promotion linked to ArTEN study that included an unlicensed once-daily Viramune arm
Applicable Code year	2008
Complaint received	09 September 2009
Case completed	27 October 2009
Appeal	No appeal
Breach clauses	Clause 3.2
No breach findings	Clause 9.1
Sanctions	Undertaking received

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

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Bristol-Myers Squibb complained about a Boehringer Ingelheim journal advertisement for Viramune (nevirapine) in HIV Medicine, July 2009.
The ad used “Have you heard?” and “New Viramune data will be coming soon”, referenced the ArTEN study, described treatment regimens, and ended “With results expected soon, you will have more reasons than ever to talk about Viramune”.
ArTEN included Viramune 200mg twice daily (licensed) and Viramune 400mg once daily (unlicensed), each with Truvada, plus an atazanavir/ritonavir arm.
The ad did not state Viramune doses, but was designed to raise awareness of forthcoming ArTEN results.
Boehringer Ingelheim said the ad was withdrawn before ArTEN results were published/presented and argued it did not promote once-daily dosing.

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Breach of Clause 3.2: the Panel considered the ad effectively promoted a study that included an unlicensed dosing regimen and was therefore inconsistent with the Viramune SPC.
No breach of Clause 9.1: the Panel did not consider the ad a “teaser” because it provided information about Viramune and included prescribing information.
The Panel also noted that any requests for ArTEN information generated by the ad would not be “unsolicited” (so responses could not rely on the Clause 1.2 exemption), and asked that Boehringer Ingelheim be advised of this view.

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