AUTH/3408/10/20: Anonymous non-contactable v Amgen (Blincyto) – No breach (prescribing information alleged out of date) | PMCPA Case

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Key facts

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Case number	AUTH/3408/10/20
Complainant	Anonymous, non-contactable (stated they were an employee of Amgen Ltd)
Company	Amgen
Product	Blincyto (blinatumomab)
Material	Detail aid (interactive digital sales aid), ref UKIE-P-103-1115-117947(1)
Allegation	Prescribing information incorrect and not the most up to date version
Applicable Code year	2019
Clauses considered	Clause 4.1; Clause 4.2
Panel decision	No breach
Complaint received	29 October 2020
Case completed	22 April 2021
Appeal	No appeal
Withdrawal/replacement of material	Withdrawn 27 May 2020 and replaced with a new detail aid

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

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An anonymous, non-contactable complainant (stating they were an Amgen employee) alleged the prescribing information (PI) on a Blincyto (blinatumomab) detail aid (ref UKIE-P-103-1115-117947(1)) was incorrect and not the most up to date.
The Authority asked Amgen to consider the requirements of Clause 4.1.
Amgen said the interactive digital sales aid promoted Blincyto for adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B‑precursor acute lymphoblastic leukaemia (ALL), and included PI dated August 2018; the aid was certified on 23 November 2018.
Amgen assumed the complaint related to a new Blincyto indication licensed in January 2019 (MRD setting) and argued the PI in the aid did not need updating because changes related to the new indication/dosing schedule and there were no new safety changes relevant to the promoted indication.
The detail aid was withdrawn on 27 May 2020 and replaced with a new detail aid.
The Panel noted the complainant provided no detail explaining why the PI was allegedly incorrect/out of date and could not be contacted for more information.

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No breach of the Code.
The Panel ruled the complainant had not discharged the burden of proof that the PI failed to meet the requirements of Clauses 4.1 and 4.2.
No appeal.

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