Accord: representative provided Methofill training devices without flagging paediatric Crohn’s use was off-label (AUTH/3682/8/22)

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Key facts

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Case number	AUTH/3682/8/22
Parties	Complainant v Accord
Medicine	Methofill (methotrexate) prefilled injector
Main issue	Representative conduct leading to off-licence promotion (paediatric Crohn’s Disease context)
Complaint received	05 August 2022
Case completed	14 July 2023
Applicable Code year	2021
Breach clauses	Clause 11.2; Clause 17.2
No breach clauses	Clause 5.1; Clause 2
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal
Notable SPC point cited	“There is not sufficient experience in the paediatric population to recommend methotrexate for the treatment of Crohn’s disease in this population.”

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

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An anonymous, non-contactable complainant alleged an Accord representative had been selling/promoting Methofill (methotrexate) off-licence to nurses.
In July 2022, a Specialist Nurse for Children’s Gastroenterology emailed requesting training material and trainer devices for the Methofill prefilled injector, noting intended use in a child with Crohn’s Disease.
The representative agreed and delivered the materials/devices the same day and demonstrated use, but did not immediately highlight that paediatric Crohn’s Disease use was outside the marketing authorisation.
The SPC stated: “There is not sufficient experience in the paediatric population to recommend methotrexate for the treatment of Crohn’s disease in this population.”
In early August 2022, during an internal weekly teleconference, a senior employee interrupted to remind the team Methofill was not licensed for paediatric Crohn’s Disease and instructed the representative to contact the nurse promptly.
The representative contacted the nurse the same day to clarify the off-label position and followed up by email a few days later.
Accord investigated, reviewed CRM entries, and found no evidence of a broader pattern, though the Panel noted another CRM entry where a nurse raised paediatric use and the representative made no comment.

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Breach found: the representative promoted Methofill outside the terms of its marketing authorisation by failing to immediately inform the nurse that paediatric Crohn’s Disease use was off-label when responding to the request and providing training devices.
No breach found for company-level high standards/discredit: the Panel considered Accord had been let down by one employee and acted promptly once aware.
No appeal.

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Breach of Clause 11.2 Promoting a medicine outside the terms of its marketing authorisation
Breach of Clause 17.2 Representative failing to maintain a high standard of ethical conduct
No Breach of Clause 5.1 Requirement to maintain high standards
No Breach of Clause 2 Requirement that activities must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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