AUTH/3312/2/20: Anonymous v Johnson & Johnson (Nicorette) — no breach over ‘out of date’ prescribing information | PMCPA Case

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Key facts

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Case number	AUTH/3312/2/20
Complainant	Anonymous (concerned UK health professional)
Company	Johnson & Johnson (complaint taken up with Johnson & Johnson Limited; ad placed by McNeil Products Ltd)
Product	Nicorette (nicotine) — 15mg inhalator PI referenced
Material	Journal advertisement (ref UK/NI/19-14927a) in Guidelines in Practice (January 2020 edition)
Issue alleged	Prescribing information dated June 2016 allegedly out of date due to SPC updates (section 4.4), with potential patient safety impact
Ad certified	November 2019
First printed	16 December 2019
SPC update (MHRA approval)	30 December 2019
SPC uploaded to eMC	14 January 2020
Company notified of SPC changes	7 January 2020
Applicable Code year	2019
Clauses considered	Clauses 2, 4.1, 9.1
Panel decision	No breach
Complaint received	19 February 2020
Case completed	29 May 2020
Appeal	No appeal

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

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An anonymous UK health professional complained about a journal advertisement for Nicorette (nicotine) (ref UK/NI/19-14927a) placed in Guidelines in Practice (January 2020 edition).
The ad’s prescribing information (PI) for the Nicorette 15mg inhalator was dated June 2016, while the advertisement was certified in November 2019 and first printed on 16 December 2019.
The complainant alleged the PI was out of date because the Nicorette inhalator SPC had been updated (they said twice) with significant changes to SPC section 4.4 (Special warnings and precautions for use), potentially affecting patient safety.
Johnson & Johnson said there was only one SPC update in that period: MHRA approved an update on 30 December 2019, uploaded to eMC on 14 January 2020; notification was received on 7 January 2020.
Johnson & Johnson said it assessed the SPC changes per SOP: if changes were critical, materials would be withdrawn; it concluded changes were not critical, drew up updated PI for future materials, and did not withdraw existing materials.
The Panel reviewed the December 2019 SPC changes (including wording changes around risk-benefit assessment, diabetes monitoring wording, and “danger in children” wording) and compared them with the June 2016 PI content.

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No breach of the Code was ruled.
The Panel found the complainant did not establish that the December 2019 SPC section 4.4 changes required consequential changes to the June 2016 prescribing information used in the ad.
The Panel found no evidence that high standards had not been maintained.

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