Janssen voluntary admission: Stelara journal insert ran with outdated prescribing information (AUTH/2801/11/15)

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Key facts

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Case number	AUTH/2801/11/15
Company	Janssen-Cilag Ltd
Product	Stelara (ustekinumab)
Material / activity	Two-page bound insert journal advertisement (ref PHGB/STE/0415/0010)
Publication(s)	Annals of Rheumatic Disease (ARD) October 2015 (advert at issue); BMJ Clinical Research 5 September 2015 (additional placement noted by Panel)
Issue	Outdated prescribing information (November 2014 PI used after June 2015 PI update)
PI update details	Added paediatric plaque psoriasis indication (≥12 years), paediatric dosing info, and availability of a 45mg vial; November 2014 PI said not recommended under 18; June 2015 PI said not recommended under 12
Applicable Code year	2015
Complaint type	Voluntary admission treated as a complaint (per Constitution and Procedure Paragraph 5.6)
Complaint received	02 November 2015
Completed	21 December 2015
Appeal	No appeal
Breach clauses	Clause 4.1 and Clause 9.1
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 voluntarily admitted that a two-page bound insert advertisement for Stelara (ustekinumab) in the Annals of Rheumatic Disease (ARD) October 2015 issue contained outdated prescribing information (PI).
The insert had been prepared, approved and certified in April 2015 and included PI dated November 2014.
Stelara PI was updated in June 2015 (including a paediatric plaque psoriasis indication from age 12, paediatric dosing information, and availability of a 45mg vial).
The publishing group reportedly overprinted the June 2015 ARD insert and, without Janssen’s knowledge or consent, inserted it into the October 2015 ARD issue.
After the voluntary admission, Janssen learned the publisher had also placed another double-page insert (prepared March 2015; also with November 2014 PI) in BMJ Clinical Research on 5 September 2015, again without Janssen’s consent/knowledge.
Janssen stated the June 2015 PI contained no additional/different safety information vs November 2014 and therefore patient safety was not put at risk.
The Panel noted the ad’s psoriasis side did not clearly restrict the promoted population to adults; readers might assume it applied to all indicated patients (including adolescents from age 12), so the PI should have reflected the updated SPC (including paediatric indication/dosing).
Janssen had an SOP for withdrawal of materials; while withdrawals were done within timelines, a teleconference briefing to the media booking agency was not followed up in writing, so the withdrawal briefing was not formally documented as required by the SOP.

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Outcome

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Breach of Clause 4.1 was ruled (as acknowledged by Janssen) because the prescribing information in the advertisement was out of date and not consistent with the SPC at time of publication.
Breach of Clause 9.1 was ruled (as acknowledged by Janssen) because high standards were not maintained, including lack of formal documentation of the agency briefing and the fact that another outdated insert also appeared in a different publication.
No appeal.

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Key facts

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