Lundbeck found in breach over public-facing product webpage and co-promotion certification failures (AUTH/3059/8/18)

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Key facts

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Case number	AUTH/3059/8/18
Complainant	Anonymous, non-contactable (appeared to be a Lundbeck employee)
Company	Lundbeck
Co-promotion partner	Otsuka
Product(s)	Abilify Maintena (aripiprazole prolonged-release suspension for injection); webpage also referenced Lundbeck products including Cipramil (citalopram) and Ebixa (memantine)
Main issues	Public-facing product webpage ruled to advertise POMs; certification failures for co-promoted promotional materials and lack of required prior notification to MHRA/PMCPA
Applicable Code year	2016
Breach clauses	14.1, 14.4, 26.1, 26.2, 28.3
Clause 14.3	No ruling (Panel considered complaint only referred to promotional material)
Complaint received	20 August 2018
Case completed	19 December 2018
Appeal	No appeal
Sanctions applied	Undertaking received; Additional sanctions: Not stated
Published	May 2019 Code of Practice Review

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

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What happened

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An anonymous, non-contactable complainant (appearing to be a Lundbeck employee) complained about: (1) the product section of Lundbeck’s UK website and (2) certification of promotional materials under a co-promotion agreement with Otsuka.
Lundbeck and Otsuka co-promoted Abilify Maintena (aripiprazole prolonged-release suspension for injection), indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
The website page listed Lundbeck prescription-only medicines in a table including brand name, non-proprietary name, dosage/formulation and indication, with wording aimed at consumers and a link to the eMC homepage.
Lundbeck could not provide a certificate/job bag summary for the webpage because it had not gone through certification when last updated (2015).
Lundbeck acknowledged discrepancies between the webpage and updated SPCs for Cipramil (citalopram) and Ebixa (memantine), attributing this to the webpage predating 2016 SPC updates.
Lundbeck stated it suspended the Lundbeck UK website and put up a holding page with obligatory medical information and pharmacovigilance contacts while it reviewed/updated/amended and certified the site.
On certification, the Panel reviewed Abilify Maintena materials/activities from Feb 2017 onwards and considered evidence including lists/spreadsheets of job bags (790 items after exclusions).
Multiple promotional items were certified by only one company, or via a medical signatory from one company plus a commercial signatory from the other (commercial signatories no longer being acceptable as final signatories under the 2016 Code).
There was no prior notification to the MHRA and PMCPA that a single signatory would certify on behalf of both companies, as required if using a single final signatory approach under co-promotion arrangements.

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Outcome

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The product webpage was ruled to advertise prescription-only medicines to the public and to be likely (on the balance of probabilities) to encourage the public to ask a health professional to prescribe a specific POM.
Multiple breaches were ruled in relation to certification and notification requirements for co-promoted promotional materials.
No ruling was made with regard to Clause 14.3 (the Panel considered the complaint only referred to promotional material).
No appeal.

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Lundbeck found in breach over public-facing product webpage and co-promotion certification failures (AUTH/3059/8/18)

Key facts

What happened

Outcome

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