Janssen voluntary admission: Zytiga ad ran twice with out-of-date prescribing information (AUTH/3106/10/18)

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Key facts

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Case number	AUTH/3106/10/18
Company	Janssen-Cilag Limited
Product	Zytiga (abiraterone)
Issue	Advertisement published with out-of-date prescribing information (November 2016 PI used instead of current November 2017 PI)
Where published	The Journal of Clinical Oncology (September 2018 issue; October 2018 issue)
How identified	Voluntary admission (self-report) after Janssen received file copies in late September 2018
Complaint received	24 October 2018
Case completed	28 January 2019
Applicable Code year	2016
Breach clauses	Clause 4.1
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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What happened

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Janssen-Cilag Limited made a voluntary admission that a Zytiga (abiraterone) advertisement (ref PHGB/ZYT/0716/0009(1)) was published twice with out-of-date prescribing information (PI).
The ad appeared in The Journal of Clinical Oncology in September 2018 (Volume 30, Issue 9) with PI dated November 2016, which had been superseded.
Zytiga PI had been updated in September 2017 and again in November 2017; the November 2017 PI was current and should have been used.
Janssen had instructed its media buyer (4 September 2017) to withdraw and destroy all ads bearing the November 2016 PI and provided updated PI (September 2017). Confirmations of deletion/destruction were received from the media buyer (11 September 2017) and publisher deletion confirmation followed (13 September 2017).
On 22 November 2017 Janssen issued a further withdrawal/destruction notification relating to materials containing the September 2017 PI and provided the November 2017 PI.
On 31 July 2018 the publisher asked the media buyer to confirm the correct print ad and attached the withdrawn ad. Although the media buyer checked with Janssen and received confirmation of the correct ad, the media buyer approved the incorrect (withdrawn) ad to the publisher.
Janssen said it was not party to the communication chain between the media buyer and the publisher and only became aware when file copies were received in late September 2018, triggering an internal investigation and self-report.
The publisher then independently re-ran the same non-compliant ad in the October 2018 issue without Janssen’s or the media buyer’s knowledge/authorisation; it was too late to halt production.
Changes missing from the November 2016 PI (vs later PI) included: removal of 250mg tablet availability and related pack/NHS cost info; addition of allergic alveolitis; addition of a new indication (newly diagnosed high risk metastatic hormone sensitive prostate cancer with ADT); steroid dose clarification; liver function test abnormalities reclassified from common to very common; addition of ‘other arrhythmias’.

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Outcome

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Breach found: Clause 4.1 (for September 2018 publication).
Breach found: Clause 4.1 (for October 2018 re-run), despite the publisher acting independently.
The Panel noted an established principle: companies are responsible for third parties even if those third parties act outside company instructions.
The Panel expressed concern about Janssen’s view that the failure had no significant patient safety implications, noting that missing/reclassified side effects could have potential patient safety implications, and requested Janssen be advised of these concerns.
No appeal.

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Key facts

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